1. Naziv propisa Evropske unije : Direktiva 98/79/EC Evropskog parlamenta i Saveta od 27. oktobra 1998 o in vitro dijagnostičkim medicinskim sredstvima 2. „CELEX” oznaka EU propisa1998L0079 3. Organ državne uprave, odnosno drugi ovlašćeni predlagač propisa: Ministarstvo zdravlja 4. Datum izrade tabele: 5. Naziv (nacrta, predloga) propisa čije odredbe su predmet analize usklađenosti sa propisom Evropske unije:Nacrt zakona o medicinskim sredstvima 6. Brojčane oznake (šifre) planiranih propisa iz baze NPAA: 2016-477 7. Usklađenost odredbi propisa sa odredbama propisa EU:
a) |a1) |b) |b1) |v) |g) |d) | |Odredba propisa EU |Sadržina odredbe |Odredbe propisa R. Srbije |Sadržina odredbe |Usklađenost |Razlozi za delimičnu usklađenost, neusklađenost ili neprenosivost |Napomena o usklađenosti | |1.1. |This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices. |član 1. st. 2. i 4. |Odredbe ovog zakona primenjuju se na medicinska sredstva za humanu upotrebu (u daljem tekstu: medicinska sredstva), uključujući in vitro dijagnostička medicinska sredstva i aktivna implantabilna medicinska sredstva.
Odredbe ovog zakona primenjuju se i na pomoćna sredstva za medicinska sredstva (pribor). |PU | | | |1.2.a. |For the purposes of this Directive, the following definitions shall apply:
(a) ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; |član 2. tačka 1)
| Izrazi upotrebljeni u ovom zakonu, ako nije drukčije određeno, imaju sledeće značenje:
1) medicinsko sredstvo (opšte) je svaki instrument, aparat, uređaj, softver, materijal i drugi proizvod koji se koristi samostalno ili u kombinaciji, uključujući i softver koji je proizvođač namenio za dijagnostičke ili terapeutske svrhe i koji je programska podrška neophodna za njegovu pravilnu primenu kod ljudi namenjenu od proizvođača, a koristi se radi:
(1) utvrđivanja dijagnoze, prevencije, praćenja, lečenja ili ublažavanja bolesti;
(2) utvrđivanja dijagnoze, praćenja, lečenja, kontrole, ublažavanja ili otklanjanja povreda ili invaliditeta,
(3) ispitivanja, zamene ili modifikacije anatomskih ili fizioloških funkcija,
(4) kontrole začeća,
i koje ne ispunjava svoju osnovnu namenu u ili na ljudskom organizmu farmakološkom, imunološkom ili metaboličkom aktivnošću, ali može u svojoj funkciji biti potpomognuto takvim sredstvima; |PU | | | |1.2.b |‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; |član 2. tačka 3) |3) in vitro dijagnostičko medicinsko sredstvo je svako medicinsko sredstvo koje je reagens, proizvod reagensa, kalibrator, kontrolni materijal, komplet reagenasa (,,kit“), instrument, aparatura, oprema ili sistem koji se koristi samostalno ili u kombinaciji, namenjen od proizvođača za upotrebu u in vitro uslovima za ispitivanje uzoraka, uključujući donacije krvi i tkiva humanog porekla, samo ili uglavnom da bi se dobile informacije za:
(1) određivanje fiziološkog ili patološkog stanja,
(2) određivanje kongenitalne anomalije,
(3) određivanje sigurnosti i kompatibilnosti sa potencijalnim primaocem,
(4) praćenje terapijskih postupaka,
Posude za uzorke smatraju se in vitro dijagnostičkim medicinskim sredstvom.
Posude za uzorke su medicinska sredstva vakuumskog ili nevakuumskog tipa koja je proizvođač izričito namenio za primarno držanje i čuvanje uzoraka dobijenih od ljuskog tela u svrhu in vitro dijagnostičkog ispitivanja.
Proizvodi za opštu laboratorijsku upotrebu ne smatraju se in vitro dijagnostičkim medicinskim sredstvom, osim ako je te proizvode, zbog svojih karakteristika, proizvođač izričito nameno za upotrebu u in vitro dijagnostičkim ispitivanjima; |PU | | | |1.2.c |‘accessory’ means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.
For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices; |član 2. tačka 2) |2) pomoćno sredstvo (pribor) je proizvod koje nije medicinsko sredstvo, a koje je proizvođač izričito namenio da se koristi u kombinaciji s medicinskim sredstvom kako bi omogućilo upotrebu tog medicinskog sredstva u skladu sa njegovom namenom određenom od proizvođača.
Invazivno sredstvo za uzorkovanje ili ono koje se direktno primenjuje na ljudsko telo u svrhu uzimanja uzoraka ne smatra se pomoćnim sredstvom za in vitro dijagnostičko medicinsko sredstvo, već se smatra opštim medicinskim sredstvom; |PU | | | |1.2.d. |‘device for self-testing’ means any device intended by the manufacturer to be able to be used by lay persons in a home environment; |član 2. tačka 10) |10) sredstvo za samotestiranje je svako in vitro dijagnostičko medicinsko sredstvo čija je namena da ga koriste nestručna lica u kućnom okruženju; |PU | | | |1.2.e. |‘device for performance evaluation’ means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises; |član 2. tačka 11) |11) sredstvo za procenu performanse je svako in vitro dijagnostičko medicinsko sredstvo koje je proizvođač namenio da bude predmet jednog ili više ispitivanja za procenu performansi u laboratorijama za medicinske analize ili u bilo kom drugom odgovarajućem okruženju van njegovih sopstvenih prostorija; |PU | | | |1.2.f. |‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devicesalready on the market to their intended purpose for an individual patient; |član 2. tačka 20) i član 1. stav 3. |20) proizvođač medicinskog sredstva (u daljem tekstu: proizvođač) je pravno ili fizičko lice odgovorno za njegov dizajn, proizvodnju, pakovanje i obeležavanje pre nego što ga stavi na tržište pod svojim imenom, bez obzira da li je ove aktivnosti izvršio samostalno ili ih je u njegovo ime izvršilo drugo lice;
Odredbe ovog zakona koje se odnose na proizvođače primenjuju se i na pravna i fizička lica koja sastavljaju sistem ili komplet, pakuju, dorađuju, potpuno obnavljaju i/ili obeležavaju jedan ili više gotovih proizvoda i određuje im namenu medicinskog sredstva u svrhu stavljanja na tržište Republike Srbije pod svojim imenom. Odredbe ovog zakona ne primenjuju se na lice koje, iako nije proizvođač, sastavlja ili prilagođava medicinsko sredstvo određene namene, koje se već nalazi na tržištu i namenjeno je određenom korisniku. |PU | | | |1.2.g. |‘authorised representative’ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive; |član 2. tačka 21) |21) ovlašćeni predstavnik proizvođača medicinskog sredstva (u daljem tekstu: ovlašćeni predstavnik proizvođača) je pravno ili fizičko lice sa sedištem u Republici Srbiji koje je inostrani proizvođač pisanim putem jedinog ovlastio da postupa u njegovo ime i da vodi postupke propisane ovim zakonom i koje je odgovorno za sigurnost i performanse određenog medicinskog sredstva na isti način kao i proizvođač tog medicinskog sredstva; |PU | | | |1.2.h. |‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials; |član 2. tačka 22) |22) namena je upotreba za koju je medicinsko sredstvo namenjeno u skladu sa podacima koje je proizvođač naveo prilikom obeležavanja, u uputstvu za upotrebu i/ili u promotivnom materijalu; |PU | | | |1.2.i. |‘placing on the market’ means the first making available in return for payment or free of charge of a device other than a device intended for performance evaluation with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished; |član 2. tačka 25) |25) stavljanje na tržište je prvo stavljanje na raspolaganje medicinskog sredstva sa ili bez naknade, u cilju distribucije i/ili upotrebe na tržištu Republike Srbije, bez obzira da li je novo ili potpuno obnovljeno, osim medicinskog sredstva namenjenog za kliničko ispitivanje; |PU | | | |1.2.j. |‘putting into service’ means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose. |član 2. tačka 26) |26) stavljanje u upotrebu je faza u kojoj je medicinsko sredstvo na raspolaganju krajnjem korisniku, spremno za upotrebu na tržištu Republike Srbije po prvi put i za njegovu predviđenu namenu; |PU | | | |1.3. |For the purposes of this Directive, calibration and control materials refer to any substance, material or article intended by their manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended use of that device. |član 2) tačka 12) |12) kalibrator i kontrolni materijal odnose se na svaku supstancu, materijal ili proizvod namenjen za određivanje mernih odnosa ili za proveru karakteristika performanse medicinskog sredstva u odnosu na njegovu namenu; |PU | | | |1.4. |For the purposes of this Directive, the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine and by any Member States regulations on this matter. | | |NP | |oblast ćelija i tkiva uređena je posebnim zakonom | |1.5. |This Directive shall not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity. This does not affect the right of Member State to subject such activities to appropriate protection requirements. |Član 22.
|Odredbe ovog zakona, osim odredbi kojima se uređuju opšti zahtevi za sigurnost i performanse medicinskog sredstva, ne primenjuju se na medicinsko sredstvo koje se izrađuje u zdravstvenoj ustanovi radi upotrebe samo u toj zdravstvenoj ustanovi, ako su ispunjeni sledeći uslovi:
1) medicinsko sredstvo nije na bilo koji način, sa ili bez naknade, dato drugom pravnom ili fizičkom licu;
2) izrada i upotreba medicinskog sredstva se obavlja u skladu sa odgovarajućim sistemom upravljanja kvalitetom;
3) zdravstvena ustanova utvrdi u svojoj evidenciji da specifične potrebe pacijenta ili grupe pacijenta ne mogu biti ispunjene ili ne mogu biti ispunjene na odgovarajućem nivou performansi ekvivalentnim medicinskim sredstvom koje je dostupno na tržištu;
4) zdravstvena ustanova na godišnjem nivou dostavi informacije o upotrebi ovih medicinskih sredstava ministarstvu, sa obrazloženjem o njihovoj proizvodnji, modifikaciji i upotrebi;
5) zdravstvena ustanova sačini izjavu da će učiniti javno dostupnim: naziv i adresu zdravstvene ustanove koja izrađuje medicinsko sredstvo, detalje neophodne za identifikaciju medicinskog sredstva, izjavu kojom garantuje da medicinsko sredstvo ispunjava opšte zahteve za sigurnost i performanse u skladu sa ovim zakonom i propisima donetim za njegovo sprovođenje, odnosno, po potrebi, informaciju koji zahtevi nisu ispunjeni, sa obrazloženjem;
6) zdravstvena ustanova izradi dokumentaciju o prostoru, opremi, kadru i, procesu izrade, dizajnu i performansama medicinskog sredstva, uključujući i namenu, a koja je dovoljno detaljna da omogući ministarstvu da utvrdi da su opšti zahtevi za sigurnost i performanse ispunjeni, u skladu sa ovim zakonom i propisima donetim za njegovo sprovođenje;
7) zdravstvena ustanova preduzme sve neophodne mere kako bi obezbedila da je medicinsko sredstvo izrađeno u skladu sa dokumentacijom iz tačke 6) ovog stava;
8) zdravstvena ustanova na osnovu iskustva stečenog od kliničke upotrebe medicinskog sredstva preduzme sve neophodne korektivne mere.
Dozvolu za izradu medicinskog sredstva iz stava 1. ovog člana zdravstvenoj ustanovi izdaje ministarstvo.
Medicinsko sredstvo koje je izrađeno u zdravstvenoj ustanovi može da se stavi u upotrebu u toj zdravstvenoj ustanovi i ne sme da se stavi na tržište Republike Srbije.
Ministarstvo može da zabrani ili ograniči izradu i/ili upotrebu medicinskog sredstva iz stava 1. ovog člana, ako zdravstvena ustanova ne ispunjava, odnosno prestane da ispunjava uslove propisane ovim zakonom i propisma donetim za njegovo sprovođenje.
Ministar propisuje uslove i postupak izdavanja dozvole za izradu, kao i opšte zahteve za sigurnost i performanse medicinskog sredstva iz stava 1. ovog člana. |PU | | | |1.6. |This Directive shall not affect national laws which provide for the supply of devices by a medical prescription | | |NP | |predmet posebnog zakona kojim se uređuje zdravstveno osiguranje | |1.7. |This Directive is a specific directive within the meaning of Article 2(2) of Directive 89/336/EEC, which shall cease to apply to devices which have complied with this Directive. | | |NP | | | |2. |Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. This involves the obligation of Member States to monitor the security and quality of these devices. This Article applies also to devices made available for performance evaluation. |član 12. stav 1. |Medicinsko sredstvo može da bude stavljeno na tržište i u upotrebu u Republici Srbiji samo ako je usaglašeno sa osnovnim zahtevima (ako je njegova usaglašenost ocenjena propisanim postupkom, ako je obeleženo u skladu sa ovim zakonom i propisima donetim za njegovo sprovođenje, ako mu je izdata odgovarajuća isprava o usaglašenosti i druga dokumentacija propisana ovim zakonom i propisima donetim za njegovo sprovođenje) i kada je pravilno nabavljeno i instalirano, održavano i upotrebljavano u skladu sa svojom namenom. | | | | |3. |Devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.
Article |član 13. stav 1. |Za medicinsko sredstvo usaglašeno sa propisanim tehničkim standardima Evropske unije ili harmonizovanim standardima Republike Srbije, kojima su prihvaćeni usglašeni tehnički standardi EU pretpostavlja se da je usaglašeno sa odgovarajućim osnovnim zahtevima propisanim ovim zakonom i i propisima donetim za njegovo sprovođenje. | | | | |4.1. |Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 16 if these devices have undergone conformity assessment in accordance with Article 9. |član 17. stav 1. |Medicinsko sredstvo može da bude stavljeno na tržište i/ili upotrebu u Republici Srbiji samo ako je obeleženo SE znakom ili srpskim znakom usaglašenosti u skladu sa zakonom (u daljem tekstu: znak usaglašenosti) kojim se dokazuje da je izvršeno ocenjivanje usaglašenosti. | | | | |4.2. |Member States shall not create any obstacle to devices intended for performance evaluation being made available for that purpose to the laboratories or other institutions listed in the statement referred to in Annex VIII if they meet the conditions laid down in Article 9(4) and Annex VIII. |član 19. stav 1.
član 2. tačka 3)
i 69. stav 5. |Medicinsko sredstvo namenjeno kliničkom ispitivanju i medicinsko sredstvo proizvedeno po narudžbini za određenog pacijenta (custom made device) na tržištu mora da prati izjava proizvođača, odnosno ovlašćenog predstavnika proizvođača o posebnoj nameni medicinskog sredstva, u skladu sa ovim zakonom i propisima donetim za njegovo sprovođenje.
Proizvodi za opštu laboratorijsku upotrebu ne smatraju se in vitro dijagnostičkim medicinskim sredstvom, osim ako je te proizvode, zbog svojih karakteristika, proizvođač izričito nameno za upotrebu u in vitro dijagnostičkim
ispitivanjima;
Upotreba medicinskog sredstva u zdravstvenoj ustanovi ne smatra se prometom medicinskog sredstva u smislu ovog zakona. | | | | |4.3. |At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devicescannot be marketed or put into service until they have been made to comply. |član 19. stav 2. |Medicinsko sredstvo namenjeno izlaganju na poslovnim sajmovima, izložbama, przentacijama i sl. ne mora da ispunjava uslove propisane ovim zakonom i propisima donetim za njegovo sprovođenje, pod uslovom da je na vidnom mestu označeno upozorenje da to medicinsko sredstvo nije usaglašeno sa osnovnim zahtevima i da je zabranjen njegov promet ili upotreba u bilo koje svrhe, dok se ne usaglasi sa osnovnim zahtevima. |PU | | | |4.4. |Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user.
Provided that safe and correct use of the device is ensured, Member States may authorise the information referred to in the first subparagraph to be in one or more other official Community language(s).
In the application of this provision, Member States shall take into account the principle of proportionality and, in particular:
(a) whether the information can be supplied by
harmonised symbols or recognised codes or other measures;
(b) the type of user anticipated for the device. |član 19. stav 3. |Informacije koje su neophodne za sigurnu upotrebu medicinskog sredstva za predviđenu namenu, a koje prate medicinsko sredstvo na tržištu i/ili u upotrebi u Republici Srbiji, moraju da budu na srpskom jeziku i napisane na razumljiv način koji uzima u obzir znanje potencijalnog korisnika, osim pakovanja medicinskog sredstva za profesionalnu upotrebu u skladu sa ovim zakonom. |PU | | | |4.5. |Where the devices are subject to other directives concerning other aspects which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other directives. However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such device |član 19. stav 4. |Kada se na medicinsko sredstvo primenjuju i drugi propisi koji nalažu stavljanje znaka usaglašenosti, taj znak je dokaz da to medicinsko sredstvo ispunjava odredbe tih propisa. |PU | | | |5.1. |Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards transposing the harmonised standards the reference numbers of which have been published in the Official Journal of the European Communities; Member States shall publish the reference numbers of such national standards. |član 13. st. 1. do 3. |Za medicinsko sredstvo usaglašeno sa propisanim tehničkim standardima Evropske unije ili harmonizovanim standardima Republike Srbije, kojima su prihvaćeni usglašeni tehnički standardi EU pretpostavlja se da je usaglašeno sa odgovarajućim osnovnim zahtevima propisanim ovim zakonom i i propisima donetim za njegovo sprovođenje.
Ministar objavljuje objedinjeni spisak harmonizovanih standarda Republike Srbije, kojima su prihvaćeni usaglašeni standardi EU iz stava 1. ovog člana.
Spisak standarda iz stava 2. ovog člana objavljuje se u ,,Službenom glasniku Republike Srbijeˮ, na obrascu čiju sadržinu propisuje ministar nadležan za poslove standardizacije. |PU | | | |5.2. |If a Member State or the Commission considers that the harmonised standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6(2). | | |NP | | | |5.3. |Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices designed and manufactured in conformity with common technical specifications drawn up for the devices in List A of Annex II and, where necessary, the devices in List B of Annex II. These specifications shall establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials. The common technical specifications shall be adopted in accordance with the procedure mentioned in Article 7(2) and be published in the Official Journal of the European Communities. Manufacturers shall as a general rule be required to comply with the common technical specifications; if for duly justified reasons manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto. Where, in this Directive, reference is made to harmonised standards, this is also meant to refer to the common technical specifications. | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |6.1. |The Commission shall be assisted by the Committee set up by Article 5 of Directive 98/34/EC (hereinafter referred to as ‘the Committee’). | | |NP | | | |6.2. |Where reference is made to this Article, Articles 3 and 7 of Decision 1999/468/EC ( 1 ) shall apply, having regard to the provisions of Article 8 thereof. | | |NP | | | |6.3. |The Committee shall adopt its rules of procedure. | | |NP | | | |7.1. |The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC. | | |NP | | | |7.2. |Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC ( 1 ) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. | | |NP | | | |7.3. |Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. | | |NP | | | |7.4. |Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. | | |NP | | | |8.1. |Where a Member State ascertains that the devices referred to in Article 4(1), when correctly installed, maintained and used for their intended purpose may compromise the health and/or safety of patients, users or, where applicable, other persons, or the safety of property, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:
(a) failure to meet the essential requirements referred to in Article 3;
(b) incorrect application of the standards referred to in Article 5, insofar as it is claimed that the standards have been applied;
(c) shortcomings in the standards themselves. |član 21. st. 1. i 2. |Ako se utvrdi da medicinsko sredstvo koje je usaglašeno sa osnovnim zahtevima, kada je ispravno instalirano, održavano i upotrebljavano u skladu sa svojom namenom, može da ugrozi zdravlje i/ili sigurnost pacijenta, korisnika ili drugog lica, ministarstvo, po prijavi ili po službenoj dužnosti, nalaže sledeće mere:
1) povlačenje sa tržišta;
2) zabranu ili ograničenje stavljanja na tržište i/ili u upotrebu;
Ministarstvo, bez odlaganja, obaveštava Agenciju i imenovano telo o preduzetim merama iz stava 1. ovoga člana, navodeći razloge, a posebno:
1) da medicinsko sredstvo ne ispunjava osnovne zahteve iz čl. 12. i 13. ovog zakona;
2) zbog nepravilne primene odredbi člana 13. ovog zakona;
3) zbog nedostataka samih tehničkih standarda.
Ako se utvrdi da medicinsko sredstvo ne ispunjava osnovne zahteve, a nosi znak usaglašenosti, ministarstvo preduzima odgovarajuće mere i o tome obaveštava Agenciju i, po potrebi, telo za ocenjivanje usaglašenosti. |PU | | | |8.2. |The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:
— the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6; where the measure referred to in paragraph 1 is attributed to problems related to the contents or to the application of the common technical specifications, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 7(1) within two months,
— the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative. | | |NP | | | |8.3. |Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever affixed the marking and shall inform the Commission and the other Member States thereof. |član 21. stav 3. |Ako se utvrdi da medicinsko sredstvo ne ispunjava osnovne zahteve, a nosi znak usaglašenosti, ministarstvo preduzima odgovarajuće mere i o tome obaveštava Agenciju. |član 21. stav 3. | | | |8.4. |The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure. | | |NP | | | |9.1. |For all devices other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before placing the devices on the market.
For all devices for self-testing other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, prior to the drawing up of the aforementioned declaration of conformity, fulfil the supplementary requirements set out in Annex III, point 6. Instead of applying this procedure, the manufacturer may follow the procedure referred to in paragraphs 2 or 3. |član 15.
član 17. |Ocenjivanje usaglašenosti u skladu sa osnovnim zahtevima, pre stavljanja na tržište vrši proizvođač, odnosno telo za ocenjivanje usaglašenosti, a tehničku procenu vrši telo za ocenjivanje usaglašenosti kontrolisanjem finalnog proizvoda prema tehničkoj specifikaciji, u skladu sa ovim zakonom i propisima donetim za njegovo sprovođenje.
Postupak ocenjivanja usaglašenosti je postupak kojim se utvrđuje i ocenjuje da li medicinsko sredstvo, odnosno njegova proizvodnja ispunjava osnovne zahteve.Postupak ocenjivanja usaglašenosti sa osnovnim zahtevima sprovodi se u zavisnosti od klase rizika medicinskog sredstva. Ako postupak ocenjivanja usaglašenosti zahteva uključivanje tela za ocenjivanje usaglašenosti, proizvođač je dužan da odabere telo za ocenjivanje usaglašenosti odgovarajućeg obima nadležnosti sa sedištem u državi članici EEA ili državi sa kojom je Evropska komisija zaključila ugovor o međusobnom priznavanju postupaka ocenjivanja usaglašenosti – notifikovano telo ili sa sedištem u Republici Srbiji – imenovano, odnosno ovlašćeno telo.
Medicinsko sredstvo može da bude stavljeno na tržište i/ili upotrebu u Republici Srbiji samo ako je obeleženo SE znakom ili srpskim znakom usaglašenosti u skladu sa zakonom (u daljem tekstu: znak usaglašenosti) kojim se dokazuje da je izvršeno ocenjivanje usaglašenosti. Pre stavljanja medicinskog sredstva na tržište i/ili u upotrebu u Republici Srbiji, ocenjivanje usaglašenosti može da sprovede, odnosno u njemu učestvuje:
1) proizvođač; 2) notifikovano telo ili imenovano, odnosno ovlašćeno telo za ocenjivanje usaglašenosti po izboru proizvođača, odnosno ovlašćenog predstavnika proizvođača.
Ministar propisuje postupke ocenjivanja usaglašenosti i vrstu isprave o usaglašenosti koju je lice iz stava 2. ovog člana dužno da obezbedi, odnosno izda za medicinsko sredstvo pre njegovog stavljanja na tržište i/ili u upotrebu. |PU | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |9.2. |For all devices referred to in List A in Annex II other than those intended for performance evaluation, the manufacturer shall, in order to affix the CE marking either:
(a) follow the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance), or
(b) follow the procedure relating to EC type-examination set out in Annex V coupled with the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |9.3. |For all devices referred to in List B in Annex II other than those intended for performance evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either:
(a) the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or
(b) the procedure relating to EC type-examination set out in Annex V couplet with:
(i) the procedure relating to EC verification set out in Annex VI, or
(ii) the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |9.4. |In the case of devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before such devices are made available.
This provision does not affect national regulations relating to the ethical aspects of carrying out performance evaluation studies using tissues or substances of human origin. | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |9.5. |During the conformity assessment procedure for a device, the manufacturer and, if involved, the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate state of manufacture. |član 27. stav 2. |U postupku ocenjivanja usaglašenosti medicinskog sredstva proizvođača i/ili imenovano telo dužno je da uzme u obzir rezultate svih operacija ocenjivanja i verifikacije koji su, po potrebi, sprovedeni u skladu sa ovim zakonom i propisima donetim za njegovo sprovođenje u fazi proizvodnje međuproizvoda. |PU | | | |9.6. |The manufacturer may instruct his authorised representative to initiate the procedures provided for in Annexes III, V, VI and VIII. | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |9.7. |The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates, established by notified bodies, and make it available to the national authorities for inspection purposes for a period ending five years after the last product has been manufactured. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorised representative. |član 15. stav 6. |Proizvođač, odnosno ovlašćeni predstavnik proizvođača dužan je da čuva izjavu o usaglašenosti, tehničku dokumentaciju propisanu ovim zakonom i propisima donetim za njegovo sprovođenje, kao i odluke, izveštaje i sertifikate izdate od tela za ocenjivanje usaglašenosti i učini ih dostupnim inspekciji ministarstva u periodu od pet godina, a u slučaju implantabilnih medicinskih sredstava najmanje 15 godina od dana proizvodnje poslednjeg medicinskog sredstva.. |PU | | | |9.8. |Where the conformity assessment procedure involves intervention of a notified body, the manufacturer, or authorised representative, may apply to a body of his choice within the framework of tasks for which the body has been notified. |član 15. stav 4. |Ako postupak ocenjivanja usaglašenosti zahteva uključivanje tela za ocenjivanje usaglašenosti, proizvođač je dužan da odabere telo za ocenjivanje usaglašenosti odgovarajućeg obima nadležnosti sa sedištem u državi članici EEA ili državi sa kojom je Evropska komisija zaključila ugovor o međusobnom priznavanju postupaka ocenjivanja usaglašenosti – notifikovano telo ili sa sedištem u Republici Srbiji – imenovano, odnosno ovlašćeno telo. |PU | | | |9.9. |The notified body may require, where duly justified, any information or data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure. |član 27. stav 8. |Imenovano telo može, kada je to opravdano, da zahteva od proizvođača, odnosno ovlašćenog predstavnika proizvođača sve informacije i podatke koji su potrebni za uspostavljanje i održavanje potvrđene usaglašenosti u odnosu na izabranu proceduru ocenjivanja usaglašenosti. |PU | | | |9.10. |Decisions taken by the notified bodies in accordance with Annexes III, IV, and V shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of up to five years. | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |9.11. |The records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body. | | |NP | | | |9.12. |By way of derogation from paragraphs 1 to 4, the competent authorities may authorise, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 4 have not been carried out and the use of which is in the interest of protection of health. |član 10. |Radi prevencije i/ili sprečavanja nastanka teških posledica po zdravlje stanovništva u slučaju epidemije, kao i u drugim vanrednim situacijama, Vlada na predlog ministra može da propiše i drugačiji način, postupak i uslove za stavljanja na tržište i registraciju medicinskih sredstava, za kliničko ispitivanje, proizvodnju, promet, kontrolu kvaliteta medicinskih sredstava, obeležavanje, vigilancu, oglašavanje, kao i primenu, odnosno upotrebu medicinskih sredstava, od uslova koji su propisani ovim zakonom i propisima donetim za njegovo sprovođenje. |PU | | | |9.13. |The provisions of this Article shall apply accordingly to any natural or legal person who manufacturers devices covered by this Directive and, without placing them on the market, puts them into service and uses them in the context of his professional activity. |Član 1.
|Ovim zakonom uređuju se uslovi za proizvodnju i promet medicinskih sredstava, odnosno njihovo stavljanje na tržište i/ili upotrebu u Republici Srbiji, klinička ispitivanja medicinskih sredstava, vigilanca, kontrola kvaliteta i praćenje medicinskih sredstava na tržištu, ocenjivanje usaglašenosti medicinskih sredstava sa osnovnim zahtevima, oglašavanje, obeležavanje medicinskih sredstava i nadzor u ovim oblastima, kao i druga pitanja od značaja za medicinska sredstva.
Odredbe ovog zakona primenjuju se na medicinska sredstva za humanu upotrebu (u daljem tekstu: medicinska sredstva), uključujući in vitro dijagnostička medicinska sredstva i aktivna implantabilna medicinska sredstva.
Odredbe ovog zakona koje se odnose na proizvođače primenjuju se i na pravna i fizička lica koja sastavljaju sistem ili komplet, pakuju, dorađuju, potpuno obnavljaju i/ili obeležavaju jedan ili više gotovih proizvoda i određuje im namenu medicinskog sredstva u svrhu stavljanja na tržište Republike Srbije pod svojim imenom. Odredbe ovog zakona ne primenjuju se na lice koje, iako nije proizvođač, sastavlja ili prilagođava medicinsko sredstvo određene namene, koje se već nalazi na tržištu i namenjeno je određenom korisniku. | | | | |10.1. |Any manufacturer who places devices on the market under his own name shall notify the competent authorities of the Member State in which he has his registered place of business:
— of the address of the registered place of business,
— of information relating to the reagents, reagent products and calibration and control materials in terms of common technological characteristics and/or analytes and of any significant change thereto including discontinuation of placing on the market; for other devices, the appropriate indications,
— in the case of devices covered by Annex II and of devices for self- testing, of all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Annex I, part A, section 3, the outcome of performance evaluation pursuant to Annex VIII, certificates and any significant change thereto, including discontinuation of placing on the market. |član 63. st. 1. do 3. |Agencija je dužan da u roku od 7 dana od dana izdavanja rešenja o registraciji medicinskog sredstva izvrši registraciju proizvođača, odnosno ovlašćenog predstavnika proizvođača (u daljem tekstu: Registar proizvođača).
Za medicinsko sredstvo iz člana 59. stav 1. ovog zakona, podatke o proizvođaču, odnosno ovlašćenom predstavniku proizvođača Agenciji dostavlja ministarstvo radi registracije u Registru proizvođača.
Za proizvođača koji pod sopstvenim imenom stavlja na tržište, odnosno u upotrebu u Republici Srbiji medicinska sredstva klase I, kao i ostala in vitro dijagnostička medicinska sredstva, osim medicinskog sredstva proizvedenog po narudžbini za određenog pacijenta (custom made device) i medicinskog sredstva namenjenog za klinička ispitivanja, u skladu ovim zakonom i propisima donetim za njegovo sprovođenje, kao i za svako pravno ili fizičko lice koje obavlja delatnosti iz člana 25. ovog zakona, Agencija unosi u Registar proizvođača podatke o adresi mesta proizvodnje medicinskog sredstva i o klasama i kategorijama tih medicinskih sredstava. | | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |10.2. |For devices covered by Annex II and for devices for self-testing, Member States may request to be informed of the data allowing identification together with the label and the instructions for use when such devices are placed on the market and/or put into service within their territory.
These measures cannot constitute a precondition for the placing on the market and/or putting into service of devices which are in conformity with this Directive. | | | | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |10.3. |Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorised representative. The authorised representative shall notify the competent authorities of the Member State in which he has his registered place of business of all particulars as referred to in paragraph 1. |član 2. tačka 21)
i član 63. st. 4. do 6. |21) ovlašćeni predstavnik inostranog proizvođača medicinskog sredstva (u daljem tekstu: ovlašćeni predstavnik proizvođača) je pravno ili fizičko lice sa sedištem u Republici Srbiji koje je inostrani proizvođač pisanim putem jedinog ovlastio da postupa u njegovo ime i da vodi postupke propisane ovim zakonom i koje je odgovorno za sigurnost i performanse određenog medicinskog sredstva na isti način kao i proizvođač tog medicinskog sredstva;
Pravna ili fizička lica na teritoriji Republike Srbije koja za potrebe proizvođača van teritorije Republike Srbije obavljaju proizvodnju ili deo proizvodnje medicinskog sredstva (uslužna proizvodnja), kao i lica koja obavljaju proizvodnju ili deo proizvodnje medicinskog sredstva isključivo radi izvoza dužna su da ministarstvu prijave delatnost proizvodnje.
Podaci iz st. 2, 3. i 4. ovog člana unose se u elektronsku bazu podataka koju vodi Agencija.
Sadržaj i način vođenja Registra proizvođača, kao i podatke iz Registra proizvođača koji se objavljuju na zvaničnoj internet stranici Agencije propisuje ministar. |PU | | | |10.4. |The notification referred to in paragraph 1 shall also include any new device. In addition, where, in the context of such notification, a device notified, bearing the CE marking, is a ‘new product’, the manufacturer shall indicate this fact on his notification.
For the purposes of this Article, a device is ‘new’ if:
(a) there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter;
(b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years. | | | | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |10.5. |Member States shall take all necessary measures to ensure that the notifications referred to in paragraphs 1 and 3 are registered immediately in the databank described in Article 12.
The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the regulatory procedure referred to in Article 7(2). | | |NP | | | |10.6. |Transitionally, pending the establishment of a European databank accessible to the competent authorities of the Member States and containing the data relating to all devices available on the territory of the Community, the manufacturer shall give such notification to the competent authorities of each Member State concerned by the placing on the market. | | |NP | | | |11.1. |Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally:
(a) any malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health;
(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer. |član 98. stav 1. |Agencija evidentira, procenjuje i preduzima mere iz svoje nadležnosti u slučaju incidenta medicinskog sredstva, i to:
1) svaku neispravnost ili izmenu karakteristika i/ili performansi medicinskog sredstva, kao i nepravilnosti u obeležavanju ili uputstvima za upotrebu koje su dovele ili ili su mogle da dovedu do smrti pacijenta ili korisnika ili do ozbiljnog pogoršanja njegovog zdravstvenog stanja;
2) svaki tehnički ili medicinski uzrok u vezi s performansama medicinskog sredstva iz tačke 1) ovog stava koji su razlog da proizvođač, odnosno ovlašćeni predstavnik proizvođača povuče sa tržišta medicinsko sredstvo istog tipa |PU | | | |11.2. |Where a Member State requires medical practitioners, the medical institutions or the organisers of external quality assessment schemes to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident. |član 98. stav 2. |O incidentu iz stava 1. ovog člana, zdravstveni radnik ili zdravstvena ustanova, odnosno koordinator za vigilancu dužan je da obavesti Agenciju i proizvođača, odnosno ovlašćenog predstavnika proizvođača. |PU | | | |11.3. |After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated. |član 98. stav 3. |O incidentu iz stava 1. ovog člana Agencija obaveštava ministarstvo i predlaže odgovarajuće mere u skladu sa ovim zakonom i propisima donetim za njegovo sprovođenje. |PU | | | |11.4. |Where, in the context of notification referred to in Article 10, a device notified, bearing the CE marking, is a ‘new’ product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience gained with the device subsequent to its being placed on the market. | | | | |Aneksi ove direktive biće implementirani kroz pravilnik, pa će osnovni zahtevi za medicinsko sredstvo biti detaljnije regulisani – prevedeni i objavljeni kroz pravilnik | |11.5. |Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2). | | |NP | | | |12.1. |Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well- informed basis.
The databank shall contain the following:
(a) data relating to registration of manufacturers and devices in accordance with Article 10;
(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;
(c) data obtained in accordance with the vigilance procedure as defined in Article 11. | | |NP | | | |12.2. |Data shall be forwarded in a standardised format. | | |NP | | | |12.3. |The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2). | | |NP | | | |13. |Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or made subject to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States, giving the reasons for its decision. The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 7(4). |član 84.
član 100. stav 4.
i
član 103. |Ministarstvo je dužno da zabrani promet i naloži da se medicinsko sredstvo povuče sa tržišta:
1) ako je određeno medicinsko sredstvo štetno pri uobičajenim uslovima primene, na predlog Agencije ili na osnovu obaveštenja dobijenog od imenovanog tela;
2) ako ne ispunjava performanse, na predlog Agencije ili na osnovu obaveštenja dobijenog od imenovanog tela;
3) ako odnos rizika i koristi nije povoljan pri odobrenim uslovima primene, na predlog Agencije;
4) ako njegov kvalitativni i kvantitativni sastav ne odgovara deklarisanom, na predlog Agencije, ili na osnovu obaveštenja dobijenog od imenovanog tela;
5) ako propisani postupci ocenjivanje usaglašenosti nisu sprovedeni po službenoj dužnosti, odnosno na predlog imenovanog tela;
6) ako je proizveden od pravnog, odnosno fizičkog lica koje nije registrovano u Registru proizvođača, odnosno kome ministarstvo nije izdalo dozvolu za proizvodnju;
7) ako za medicinsko sredstvo nije podnet zahtev za registraciju;
8) ako nema odgovarajuću ispravu o usaglašenosti;
9) ako je medicinsko sredstvo koje je na tržištu falsifikovano ili postoji sumnja da je falsifikovano, na predlog Agencije ;
10) ako je medicinskom sredstvu istekao rok upotrebe;
11) u drugim slučajevima kada je medicinsko sredstvo na tržištu suprotno uslovima propisanim ovim zakonom i propisima donetim za njegovo sprovođenje.
Radi obezbeđivanja sistema vigilance , Agencija sarađuje sa nadležnim organima zemalja „EEA“ i Evropskom Komisijom, kao i sa „EUDAMED”, „CAMD“, Svetskom zdravstvenom organizacijom, nadležnim organima drugih zemalja odgovornih za javno zdravlje ili profesionalna oboljenja, notifikovanim i imenovanim telima, fondovima zdravstvenog osiguranja, profesionalnim udruženjima, distributerima, kao i drugim telima koja raspolažu podacima o riziku povezanom sa medicinskim sredstvom.
XIV. PROCEDURE ZA ZAŠTITU OD OZBILJNE PRETNJE PO JAVNO ZDRAVLJE Član 103.
Agencija i ministarstvo preduzimaju sve potrebne mere za zaštitu javnog zdravlja i sigurnosti pacijenata, korisnika i drugih lica uključujući i zdravstvene radnike od rizika koje može izazvati medicinsko sredstvo.
Ministarstvo u cilju zaštite javnog zdravlja može da zabrani proizvodnju ili promet medicinskog sredstva.
Ako ministarstvo proceni da medicinsko sredstvo predstavlja neprihvatljiv rizik po javno zdravlje ili sigurnost pacijenata, korisnika ili drugih lica, ili u drugim aspektima zaštite javnog zdravlje, kao i ako ne ispunjava uslove propisane ovim zakonom i propisima donetim za njegovo sprovođenje, bez odlaganja će naložiti proizvođaču, odnosno ovlašćenom predstavniku proizvođača da preduzme sve odgovarajuće i opravdane preventivne i/ili korektivne mere, da zabrani ili ograniči stavljanje medicinskog sredstva na tržište, da stavljanje medicinskog sredstva na tršište uslovi specifičnim zahtevima, da naloži povlačenje ili povlačenje medicinskog sredstva u razumnom roku sa tržišta, a proporcionalno prirodi rizika, odnosno neusaglašenosti sa odredbama ovog zakona i propisa donetih za njegovo sprovođenje. Ministarstvo može preduzeti i sve druge neophodne i opravdane mere u skladu sa zakonom.
Ako Agencija utvrdi da medicinsko sredstvo ili medicinsko sredstvo proizvedeno po narudžbini za određenog pacijenta, iako je pravilno instalirano, održavano i korišćeno u skladu sa predviđenim načinom upotrebe, može da ugrozi zdravlje i sigurnost pacijenata, korisnika, ili drugih lica ili njihovu imovinu, Agencija predlaže ministarstvu da obustavi, zabrani promet ili upotrebu medicinskog sredstva, ili da naloži povlačenje medicinskog sredstva sa tržišta.
Agencija blagovremeno i na odgovarajući način, informiše sva lica koja mogu biti izložena opasnosti od medicinskog sredstva.
Zvanično upozorenje javnosti, pored obaveštenja na zvaničnoj internet stranici Agencije, daje se samo u slučaju nastupajuće opasnosti kada druge jednako efikasne mere ne mogu da se preduzmu ili ne mogu da se preduzmu blagovremeno.. |PU | | | |14.1. |Where a Member State considers that:
(a) the list of devices in Annex II should be amended or extended; or
(b) the conformity of a device or category of devices should be established, by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9,
it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.
Where those measures concern matters referred to in point (a), designed to amend non-essential elements of this Directive, they shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
Where those measures concern matters referred to in point (b), they shall be adopted in accordance with the regulatory procedure referred to in Article 7(2). | | |NP | | | |14.2. |When a measure is to be taken in accordance with paragraph 1, due consideration shall be given to:
(a) any relevant information available from the vigilance procedures and from external quality assessment schemes as referred to in Article 11;
(b) the following criteria:
(i) whether total reliance has to be placed on the result obtained with a given device, this result having a direct impact on subsequent medical action, and
(ii) whether action taken on the basis of an incorrect result obtained using a given device could prove to be hazardous to the patient, to a third party or to the public, in particular as a consequence of false positive or false negative results, and
(iii) whether the involvement of a notified body would be conducive to establishing the conformity of the device. | | |NP | | | |14.3. |The Commission shall inform the Member States of the measures taken and, where appropriate, publish these measures in the Official Journal of the European Communities. | | |NP | | | |15.1. |Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 9 and the specific tasks for which the bodies have been designated. The Commission shall assign identification numbers to these bodies, hereinafter referred to as ‘notified bodies’.
The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It shall ensure that the list is kept up to date.
Member States shall not be obliged to designate a notified body. | | |NP | |Registar imenovanih tela vodi ministartsvo nadležno za polove privrede | |15.2. |Member States shall apply the criteria set out in Annex IX for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the relevant criteria. |član 26. |Telo za ocenjivanje usaglašenosti sa sedištem u Republici Srbiji mora da bude akreditovano od akreditacionog tela Republike Srbije u skladu sa zakonom i imenovano od ministra za obavljanje određenih poslova ocenjivanja usaglašenosti.
Telo za ocenjivanje usaglašenosti mora da ispuni osnovne zahteve u odnosu na obim poslova sadržanih u aktu o akreditaciji iz stava 1. ovog člana, a naročito u pogledu:
1) stručne osposobljenosti zaposlenih i drugih angažovanih lica;
2) prostora i opreme;
3) nezavisnosti i nepristrasnosti u odnosu na lica povezana sa medicinskim sredstvom koje je predmet ocenjivanja usaglašenosti;
4) postupanja sa prigovorima na njegov rad i donete odluke;
5) čuvanja poslovne tajne;
6) osiguranja od odgovornosti za štetu.
Akt o akreditaciji iz stava 1. ovog člana smatra se dokazom da je telo za ocenjivanje usaglašenosti kompetentno za ocenjivanje usaglašenosti sa osnovnim zahtevima u odnosu na poslove iz obima akreditacije koji je sastavni deo akta o akreditaciji, odnosno u odnosu na postupak ocenjivanja usaglašenosti medicinskog sredstva određene vrste i klase. Akreditaciono telo Republike Srbije može da zatraži mišljenje ministarstva u pogledu predloženog obima akreditacije. Ministarstvo može da učestvuje u postupku akreditacije tela za ocenjivanje usaglašenosti u svojstvu posmatrača, na predlog akreditacionog tela Republike Srbije uz saglasnost podnosioca zahteva.
Rešenje o imenovanju tela za ocenjivanje usaglašenosti donosi ministar u skladu sa zakonom kojim se uređuje opšti upravni postupak. U postupku imenovanja tela za ocenjivanje usaglašenosti može učestvovati akreditaciono telo Republike Srbije u svojstvu posmatrača, na predlog ministarstva, uz saglasnost podnosioca zahteva.
Ako ministarstvo utvrdi da je imenovano telo prestalo da ispunjava uslove iz st. 1. i 2. ovog člana ili da ne izvršava svoje obaveze u skladu sa zakonom, ministar donosi rešenje o ukidanju rešenja iz stava 4. ovog člana u skladu sa zakonom kojim se uređuje opšti upravni postupak.
Pre donošenja rešenja iz stava 5. ovog člana, ministar može, uzimajući u obzir vrstu nedostataka u pogledu ispunjavanja osnovnih zahteva ili izvršavanja obaveza, u pisanoj formi da upozori imenovano telo i odredi rok za otklanjanje tih nedostataka koji ne može biti duži od 60 dana.
Rešenje iz stava 5. ovog člana konačno je u upravnom postupku i protiv njega se može pokrenuti upravni spor.
U slučaju donošenja rešenja iz stava 5. ovog člana ili u slučaju da imenovano telo prestane sa radom, ministar nalaže tom telu da u određenom roku izvrši prenos dokumentacije koja se odnosi na ocenjivanje usaglašenosti drugom imenovanom telu, po izboru proizvođača, odnosno omogući dostupnost te dokumentacije nadležnim organima.
Registar imenovanih tela vodi ministarstvo nadležno za poslove privrede u skladu sa zakonom.
Ministarstvo objavljuje i ažuruira spisak imenovanih tela na svojoj zvaničnoj internet stranici. |PU | | | |15.3. |Member States shall apply continual surveillance of notified bodies to ensure ongoing compliance with the criteria set out in Annex IX. A Member State that has notified a body shall withdraw or restrict that notification if it finds that the body no longer meets the criteria referred to in Annex IX. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it. |član 26.. stav 6. |Ako ministarstvo utvrdi da je imenovano telo prestalo da ispunjava uslove iz st. 1. i 2. ovog člana ili da ne izvršava svoje obaveze u skladu sa zakonom, ministar donosi rešenje o ukidanju rešenja iz stava 4. ovog člana u skladu sa zakonom kojim se uređuje opšti upravni postupak. |NP | | | |15.4. |The notified body and the manufacturer, or his authorised representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII. |član 27. stav 1. |Imenovano telo i proizvođač ili ovlašćeni predstavnik proizvođača sporazumno određuju rokove za izvršenje postupaka ocenjivanja usaglašenosti i verifikaciju usaglašenosti propisane ovim zakonom i propisima donetim za njegovo sprovođenje, koji se odnose na ispitivanje tipa, verifikaciju, obezbeđenje kvaliteta proizvodnje i obezbeđenje kvaliteta medicinskog sredstva. |PU | | | |15.5. |The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. It shall also make available, on request, all additional relevant information. | | | | | | |15.6. |Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission |član 27. stav 5. |Kad imenovano telo ustanovi da osnovni zahtevi nisu ispunjeni ili da ih proizvođač više ne ispunjava ili da sertifikat nije trebao da bude izdat, u odnosu na vrstu i obim neusaglašenosti imenovano telo je dužno da obustavi, povuče ili ograniči izdati sertifikat, osim ako proizvođač primenom odgovarajućih korektivnih mera obezbedi usaglašenost sa osnovnim zahtevima. U slučaju obustavljanja, povlačenja, odnosno ograničenja sertifikata imenovano telo obaveštava ministarstvo i Agenciju. |PU | | | |15.7. |The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with Annex IX requirements. |član 27. stav 6. |Imenovano telo, na zahtev ministarstva dostavlja relevantne informacije i dokumentaciju, uključujući finansijsku dokumentaciju potrebnu da ministarstvo proveri poštovanje osnovnih zahteva u odnosu na obeležavanje srpskim znakom usaglašenosti. |PU | | | |16.1. |Devices, other than devices for performance evaluation, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market. |član 18. stav 1 . |Medicinsko sredstvo koje se smatra usaglašenim sa osnovnim zahtevima, osim medicinskog sredstva proizvedenog po narudžbini za određenog pacijenta (custom made device) ili namenjenog kliničkom ispitivanju, mora da nosi znak usaglašenosti kada se stavlja na tržište Republike Srbije. |PU | | | |16.2. |The CE marking of conformity, as shown in Annex X, must appear in a visible, legible and indelible form on the device, where practicable and appropriate, and on the instructions for use. The CE marking of conformity must also appear on the sales packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes III, IV, VI and VII. |član 18. stav 2. |Znak usaglašenosti mora da bude vidljiv, čitljiv i neizbrisiv na samom medicinskom sredstvu ili na pakovanju koje obezbeđuje sterilnost, kad je to izvodljivo i primenljivo, kao i na uputstvu za upotrebu. Ako je primenjivo, znak usaglašenosti mora da bude i na prodajnom, odnosno komercijalnom pakovanju. |PU | | | |16.3. |It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced. |član 18. stav 3. |Zabranjeno je isticati oznake ili natpise koji bi treća lica mogli da dovedu u zabludu u odnosu na značenje ili grafički izgled znaka usaglašenosti. Druga oznaka može da se stavi na medicinsko sredstvo, pakovanje ili uputstvo za upotrebu samo ako se time ne umanjuje vidljivost i čitljivost znaka usaglašenosti. |PU | | | |17.1. |Without prejudice to Article 8:
(a) where a Member State establishes that the CE marking has been wrongly affixed, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;
(b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8. |član 20. st. 1. i 2. |Ako ministarstvo utvrdi da je znak usaglašenosti stavljen neopravdano ili nije stavljen, proizvođač ili ovlašćeni predstavnik proizvođača, odnosno uvoznik medicinskog sredstva koje nije registrovano iz člana 78. ovog Zakona dužan je da bez odlaganja preduzme odgovarajuće korektivne mere.
Ako proizvođač ili ovlašćeni predstavnik proizvođača, odnosno uvoznik ne preduzme odgovarajuće korektivne mere u slučaju iz stava 1. ovog člana, ministarstvo je dužno da ograniči ili zabrani stavljanje na tržište tog medicinskog sredstva, odnosno da preduzme mere za njegovo povlačenje u skladu sa članom 21. ovog zakona |PU | | | |17.2. |The provisions stated in paragraph 1 shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive |član 20. stav 3. |Odredbe st. 1. i 2. ovog člana primenjuju se i ako je znak usaglašenosti stavljen u skladu sa ovim zakonom na proizvode na koje se ovaj zakon ne primenjuje. | | | | |18.1. |Any decision taken pursuant to this Directive:
(a) to refuse or restrict the placing on the market or any making available or putting into service of a device, or
(b) to withdraw devices from the market,
shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the partyconcerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject. | | |NP | |Na donošenje i ukidanje rešenj koje donosi Agencija i Ministarstvo zdravlja primenjuje se Zakon o opštem upravnom postupku | |18.2. |In the event of a decision as referred to in paragraph 1, the manufacturer or his authorised representative shall have an opportunity to put forward his point of view in advance, unless such consultation is not possible because of the urgency of the measure to be taken as justified in particular by public health requirements. | | |NP | |Na donošenje i ukidanje rešenj koje donosi Agencija i Ministarstvo zdravlja primenjuje se Zakon o opštem upravnom postupku | |19. |Without prejudice to national law and practice on medical secrecy, Member States shall ensure that all the parties involved in the application of this Directive are bound to observe confidentiality with regard to information obtained in carrying out their tasks. This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law. |član 11. |Zaposleni u Agenciji, članovi organa i savetodavnih tela Agencije, stručnjaci sa liste stručnjaka, kao i zaposleni u ministarstvu dužni su da kao poslovnu tajnu čuvaju sve podatke iz dokumentacije koja se prilaže uz zahtev za registraciju medicinskog sredstva, kao i u drugim postupcima koji se vode pred Agencijom, odnosno u ministarstvu, naročito ako:
1) su podaci tajni, odnosno koji kao celina ili u preciznom obliku i skupu svojih komponenata nisu opšte poznati ili nisu lako dostupni licima koja se uobičajeno bave tom vrstom informacija;
2) podaci imaju komercijalnu vrednost zbog svoje tajnosti i to u periodu trajanja te tajnosti;
3) podaci za koje proizvođač, odnosno ovlašćeni predstavnik proizvođača preduzima, pod datim okolnostima, razumne korake da ih održi tajnim.
Lica iz stava 1. ovog člana kao poslovnu tajnu čuvaju i podatke iz dokumentacije za registraciju medicinskog sredstva, izmene i dopune, odnosno produženje registracije, koji se odnose na neotkrivena ispitivanja medicinskih sredstava.
Radi suzbijanja nelojalne konkurencije, zaposleni i lica iz stava 1. ovog člana ne smeju da otkrivaju informacije iz dokumentacije koja je podneta u postupku registracije medicinskog sredstva, kao i u drugim postupcima koji se vode pred Agencijom, odnosno ministarstvom, osim uz saglasnost proizvođača, odnosno ovlašćenog predstavnika proizvođača, odnosno podnosioca zahteva za druge postupke koji se vode pred Agencijom, odnosno ministarstvom, kao i osim podataka koji su dostupni stručnoj i opštoj javnosti radi davanja informacija o medicinskom sredstvu koje su neophodne za upotrebu, odnosno rukovanje, kao i zaštitu javnog zdravlja.
U slučaju povrede obaveze iz st. 1, 2. i 3. ovog člana primenjuju se propisi koji se odnose na zaštitu poslovne tajne.Na zaštitu podataka iz stava 2. ovog člana primenjuju se propisi o zaštiti intelektualne svojine. |PU | | | |20. |Member States shall take appropriate measures to ensure that competent authorities charged with the implementation of this Directive cooperate with each other and convey to each other the information necessary to ensure application in compliance with this Directive | | |NP | | | |21.1. |In Directive 98/37/EC, ◄ the second indent of Article 1(3), ‘machinery for medical use, used in direct contact with patients’ shall be replaced by the following:
‘— medical devices,’. | | |NP | | | |21.2. |Directive 93/42/EEC is hereby amended as follows:
(a) in Article 1(2):
— point (c) shall be replaced by the following:
‘(c) “in vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations,
derived from the human body, solely or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. “Specimen receptacles” are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;’
— point (i) shall be replaced by the following:
‘(i) “putting into service” means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose;’
— the following point shall be added:
‘(j) “authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive;’ (b) Article 2 shall be replaced by the following:
‘Article 2 Placing on the market and putting into service
Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied andproperly installed, maintained and used in accordance with their intended purpose.’
(c) the following paragraph shall be added to Article 14(1):
‘For all medical devices of classes IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.’ (d) the following Articles shall be inserted:
‘Article 14a European databank
1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.
The databank shall contain the following:
(a) data relating to registration of manufacturers and devices in accordance with Article 14;
(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Annexes II to VII;
(c) data obtained in accordance with the vigilance procedure as defined in Article 10;
2. Data shall be forwarded in a standardised format.
3. The procedures implementing this Article shall be adopted in accordance with the procedure laid down in Article 7(2).
Article 14b Particular health monitoring measures
Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States giving the reasons for its decision. The Commission shall, whenever possible, consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2).’
(e) the following paragraphs shall be added to Article 16:
‘5. The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. It shall also make available, on request, all additional relevant information.
6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission.
7. The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Member State to verify compliance with Annex XI requirements.’
(f) the following paragraph shall be added to Article 18:
‘Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.’
(g) in Article 22(4), the first subparagraph shall be replaced by the following:
‘4. Member States shall accept:
— devices which conform to the rules in force in their territory on 31 December 1994 being placed on the market during a period of five years following the adoption of this Directive, and
— the aforementioned devices being put into service until 30 June 2001 at the latest.’
(h) Annex II, section 6.2, Annex III, section 7.1, Annex V, section 5.2 and Annex VI, section 5.2 shall be deleted; (i) in Annex XI, section 3 the following sentence shall be inserted after the second sentence: ‘This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I.’ | | |NP | | | |22.1. |Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 7 December 1999. They shall immediately inform the Commission thereof. Member States shall apply these provisions with effect from 7 June 2000. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. | | |NP | | | |22.2. |Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. | | |NP | | | |22.3. |The Committee referred to in Article 7 may undertake its tasks from the date of entry into force of this Directive. The Member States may take the measures referred to in Article 15 as from the entry into force of this Directive | | |NP | | | |22.4. |Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 9 for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant test and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices. | | |NP | | | |22.5. |During a period of five years following the entry into force of this Directive, Member States shall accept the placing on the market of devices which conform to the rules in force in their territory on the date on which this Directive enters into force. For an additional period of two years, the said devices may be put into service. | | |NP | | | |23. |This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. | | |NP | | | |24. |This Directive is addressed to the Member States | | |NP | | | |ANNEX I
|ESSENTIAL REQUIREMENTS | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX II
|LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3) | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX III
|EC DECLARATION OF CONFORMITY | | |NI | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX IV
|EC DECLARATION OF CONFORMITY | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX V
|EC TYPE-EXAMINATION | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX VI
|EC VERIFICATION | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX VII
|EC DECLARATION OF CONFORMITY | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX VIII
|STATEMENT AND PROCEDURES CONCERNING DEVICES FOR PERFORMANCE EVALUATION | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX IX
|CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |ANNEX X
|CE MARKING OF CONFORMITY | | |NU | |Aneksi ove direktive biće implementirani kroz pravilnik- osnovni zahtevi prevedeni i objavljeni kroz pravilnik | |