natgillin/translations-raw huggingface dataset:
WHEREAS Decision (EU) 2017/1324 of the European Parliament and of the Council [3] regulates the terms and conditions for the participation of the Member States of the Union and third countries associated to Horizon 2020 - the Framework Programme for Research and Innovation 2014-2020 (‘Horizon 2020’) which are Participating States of the initiative, in particular their financial obligations and participation in the governing structures of the initiative;
12.
WHEREAS in accordance with Decision (EU) 2017/1324 Egypt is to become a Participating State in the Partnership for Research and Innovation in the Mediterranean Area (‘PRIMA’) subject to the conclusion of an international agreement for scientific and technological cooperation with the Union setting out the terms and conditions for the participation of Egypt in PRIMA;
Odluka (EU) 2017/1324 Europskog parlamenta i Vijeća od 4. srpnja 2017. o sudjelovanju Unije u Partnerstvu za istraživanja i inovacije na mediteranskom području (PRIMA), koje zajednički poduzima više država članica (SL L 185, 18.7.2017., str. 1.).
Decision No 1/2017 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment
Odluka br.
of 28 July 2017
1/2017 Odbora osnovanog u okviru Sporazuma između Europske zajednice i Švicarske konfederacije o uzajamnom priznavanju u vezi s ocjenom sukladnosti
on the amendment of Chapter 4 on medical devices, Chapter 6 on pressure vessels, Chapter 7 on radio equipment and telecommunication terminal equipment, Chapter 8 on equipment and protective systems intended for use in potentially explosive atmosphere, Chapter 9 on electrical equipment and electromagnetic compatibility, Chapter 11 on measuring instruments, Chapter 15 on medicinal products, GMP inspection and batch certification, Chapter 17 on lifts, and Chapter 20 on explosives for civil use, and the update of legal references listed in Annex 1 [2017/2118]
od 28. srpnja 2017.
THE COMMITTEE,
o izmjeni poglavlja 4. o medicinskim proizvodima, poglavlja 6. o tlačnim posudama, poglavlja 7. o radijskoj opremi i opremi telekomunikacijskih terminala, poglavlja 8. o opremi i zaštitnim sustavima za upotrebu u eksplozivnoj atmosferi, poglavlja 9. o električnoj opremi i elektromagnetskoj kompatibilnosti, poglavlja 11. o mjernim instrumentima i pretpakiranjima, poglavlja 15. o nadzoru dobre proizvodne prakse (DPP) lijekova i certificiranju serije, poglavlja 17. o dizalima i poglavlja 20. o eksplozivima za civilnu uporabu i o ažuriranju pravnih osnova navedenih u Prilogu I. [2017/2118]
Having regard to the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (‘the Agreement’) and in particular Articles 10(4), 10(5) and 18(2) thereof;
ODBOR,
Whereas:
uzimajući u obzir Sporazum između Europske zajednice i Švicarske Konfederacije o uzajamnom priznavanju u vezi s ocjenom sukladnosti („Sporazum”), a posebno njegov članak 10. stavke 4. i 5. te članak 18. stavak 2.,
The Parties to the Agreement have agreed to adapt Chapter 4, Medical devices, of Annex 1 in order to foster the cooperation among the regulators in the area of medical devices;
budući da:
The European Union has adopted a new Directive on simple pressure vessels [1] and a new Directive on pressure equipment [2] and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Stranke sporazuma suglasile su se prilagoditi poglavlje 4. o medicinskim proizvodima iz Priloga I. u cilju poticanja suradnje među regulatorima u području medicinskih proizvoda.
Chapter 6, Pressure vessels, of Annex 1 should be amended to reflect these developments;
Europska unija donijela je novu direktivu o jednostavnim tlačnim posudama [1] i novu direktivu o tlačnoj opremi [2], a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
The European Union has adopted a new Directive on radio equipment [3] and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
Chapter 7, Radio equipment and Telecommunications terminal equipment, of Annex 1 should be amended to reflect these developments;
Poglavlje 6.
The European Union has adopted a new Directive on equipment and protective systems intended for use in potentially explosive atmosphere [4] and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Tlačne posude Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
Chapter 8, Equipment and protective systems intended for use in potentially explosive atmosphere, of Annex 1 should be amended to reflect these developments;
Europska unija donijela je novu direktivu o radijskoj opremi [3], a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
The European Union has adopted a new Directive on electrical equipment [5] and a new Directive on electromagnetic compatibility [6] and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
Chapter 9, Electrical equipment and Electromagnetic compatibility, of Annex 1 should be amended to reflect these developments;
Poglavlje 7.
The European Union has adopted a new Directive on non-automatic weighing instruments [7] and a new Directive on measuring instruments [8] Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Radijska oprema i oprema telekomunikacijskih terminala Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
Chapter 11, Measuring instruments and prepackages, of Annex 1 should be amended to reflect these developments;
Europska unija donijela je novu direktivu o opremi i zaštitnim sustavima namijenjenima za uporabu u potencijalno eksplozivnim atmosferama [4],a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
The Parties to the Agreement have agreed to amend Chapter 15, Medicinal products GMP Inspection and Batch Certification, of Annex 1 in order to enable the recognition of results of GMP inspections carried out by the relevant inspection services of the other Party in third countries;
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
The European Union has adopted a new Directive on lifts [9] and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Poglavlje 8.
Chapter 17, Lifts, of Annex 1 should be amended to reflect these developments;
Oprema i zaštitni sustavi za uporabu u eksplozivnoj atmosferi Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
The European Union has adopted a new Directive on explosives for civil use [10] and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Europska unija donijela je novu direktivu o električnoj opremi [5] i novu direktivu o elektromagnetskoj kompatibilnosti [6], a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
Chapter 20, Explosives for civil use, of Annex 1 should be amended to reflect these developments;
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
It is necessary to update the legal references in Chapters 3, 12, 14, 16, 18 and 19 of Annex 1 to the Agreement;
Poglavlje 9.
Article 10(5) of the Agreement provides that the Committee may, on a proposal from one of the Parties, modify the Annexes to the Agreement,
Električna oprema i elektromagnetska kompatibilnost Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
HAS DECIDED AS FOLLOWS:
Europska unija donijela je novu direktivu o neautomatskim vagama [7] i novu direktivu o mjernim instrumentima [8], a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
Chapter 4, Medical devices, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment A annexed to this Decision.
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
Chapter 6, Pressure vessels, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment B annexed to this Decision.
Poglavlje 11.
Chapter 7, Radio equipment and Telecommunication terminal equipment, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment C annexed to this Decision.
Mjerni instrumenti i pretpakiranja Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
Chapter 8, Equipment and protective systems intended for use in potentially explosive atmosphere, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment D to this Decision.
Stranke Sporazuma suglasile su se oko izmjene poglavlja 15.
Chapter 9, Electrical equipment and electromagnetic compatibility, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment E to this Decision.
Nadzor dobre proizvodne prakse (DPP) lijekova i certificiranje serije Priloga 1. kako bi omogućile priznavanje rezultata nadzora dobre proizvodne prakse koji provode nadležne inspekcijske službe druge stranke u trećim zemljama.
Chapter 11, Measuring instruments and prepackages, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment F to this Decision.
Europska unija donijela je novu direktivu o dizalima [9], a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
Chapter 15, Medicinal products, GMP inspection and batch certification, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment G to this Decision.
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
Chapter 17, Lifts, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment H to this Decision.
Poglavlje 17.
Chapter 20, Explosives for civil use, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment I to this Decision.
Dizala Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment J annexed to this Decision.
Europska unija donijela je novu direktivu o eksplozivima za civilnu upotrebu [10], a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
This Decision, done in duplicate, shall be signed by representatives of the Committee who are authorised to act on behalf of the Parties.
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
This Decision shall be effective from the date of the later of these signatures.
(16) Poglavlje 20.
On behalf of the Swiss Confederation
Eksplozivi za civilnu upotrebu Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
Signed in Bern on 28 July 2017
Potrebno je ažurirati pravnu osnovu u poglavljima 3., 12., 14., 16., 18. i 19.
On behalf of the European Union
Priloga 1.
Signed in Brussels on 27 July 2017
Sporazumu.
Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45).
Člankom 10. stavkom 5.
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164).
Sporazuma predviđa se da Odbor smije, na prijedlog jedne od stranaka, izmijeniti priloge Sporazumu,
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
ODLUČIO JE: 1.
Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309).
Poglavlje 4.
Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).
Medicinski proizvodi Priloga 1.
Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79).
Sporazumu mijenja se u skladu s odredbama iz Dodatka A priloženog ovoj Odluci.
Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107).
2.
Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149).
Poglavlje 6.
Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).
Tlačne posude Priloga 1.
Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1).
Sporazumu mijenja se u skladu s odredbama iz Dodatka B priloženog ovoj Odluci.
ATTACHMENT A
3.
In Annex 1, Product Sectors, Chapter 4, Medical devices should be deleted and replaced by the following one:
Poglavlje 7.
‘CHAPTER 4
Radijska oprema i oprema telekomunikacijskih terminala Priloga 1.
MEDICAL DEVICES
Sporazumu mijenja se u skladu s odredbama iz Dodatka C priloženog ovoj Odluci.
SECTION I
3.
Legislative, regulatory and administrative provisions
Poglavlje 8.
Provisions covered by Article 1(2)
Oprema i zaštitni sustavi za upotrebu u eksplozivnoj atmosferi Priloga 1.
European Union
Sporazumu mijenja se u skladu s odredbama iz Dodatka D priloženog ovoj Odluci.
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p.
4.
1)
Poglavlje 9.
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003, p.
Električna oprema i elektromagnetska kompatibilnost Priloga 1.
1)
Sporazumu mijenja se u skladu s odredbama iz Dodatka E priloženog ovoj Odluci.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p.
5.
1), as last amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003, p.
Poglavlje 11.
1) and corrected by Corrigenda (OJ L 22, 29.1.1999, p.
Mjerni instrumenti i pretpakiranja Priloga 1.
75 and OJ L 6, 10.1.2002, p.
Sporazumu mijenja se u skladu s odredbama iz Dodatka F priloženog ovoj Odluci.
70)
6.
Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p.
Poglavlje 15.
17)
Nadzor dobre proizvodne prakse (DPP) lijekova i certificiranje serije Priloga 1.
Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p.
Sporazumu mijenja se u skladu s odredbama iz Dodatka G priloženog ovoj Odluci.
43)
Poglavlje 17.
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p.
Dizala Priloga 1.
3)
Sporazumu mijenja se u skladu s odredbama iz Dodatka H priloženog ovoj Odluci.
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p.
Poglavlje 20.
41)
Eksplozivi za civilnu upotrebu Priloga 1.
Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation (OJ L 379, 28.12.2006, p.
Sporazumu mijenja se u skladu s odredbama iz Dodatka I priloženog ovoj Odluci.
98)
10.
Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L 247, 21.9.2007, p.
Prilog 1.
21)
Sporazumu mijenja se u skladu s odredbama iz Dodatka J priloženog ovoj Odluci.
Commission Decision 2011/869/EU of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (OJ L 341, 22.12.2011, p.
Ovu Odluku, sastavljenu u dva primjerka, potpisuju predstavnici Odbora koji su ovlašteni djelovati u ime stranaka.
63)
Ova Odluka stupa na snagu od datuma zadnjeg potpisa.
Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and the Council on in-vitro diagnostic medical devices (OJ L 341, 22.12.2011, p.
U ime Švicarske Konfederacije
50)
Potpisano u Bernu 28. srpnja 2017.
Directive 2011/65/EU of the European Parliament and the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p.
U ime Europske unije
88)
Potpisano u Bruxellesu 27. srpnja 2017.
Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p.
Direktiva 2014/29/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje na tržištu jednostavnih tlačnih posuda (SL L 96, 29.3.2014., str. 45.).
45)
Direktiva 2014/68/EU Europskog parlamenta i Vijeća od 15. svibnja 2014. o usklađivanju zakonodavstava država članica o stavljanju na raspolaganje na tržištu tlačne opreme (SL L 189, 27.6.2014., str. 164.).
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p.
Direktiva 2014/53/EU Europskog parlamenta i Vijeća od 16. travnja 2014. o usklađivanju zakonodavstava država članica o stavljanju na raspolaganje radijske opreme na tržištu i stavljanju izvan snage Direktive 1999/5/EZ (SL L 153, 22.5.2014., str. 62.).
28)
Direktiva 2014/34/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na opremu i zaštitne sustave namijenjene za uporabu u potencijalno eksplozivnim atmosferama (SL L 96, 29.3.2014., str. 309.).
Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p.
Direktiva 2014/35/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje na tržištu električne opreme namijenjene za uporabu unutar određenih naponskih granica (SL L 96, 29.3.2014., str. 357.).
8)
Direktiva 2014/30/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na elektromagnetsku kompatibilnost (SL L 96, 29.3.2014., str. 79.).
Switzerland
Direktiva 2014/31/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje neautomatskih vaga na tržište (SL L 96, 29.3.2014., str. 107.).
Federal Law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended 1 January 2014 (RO 2013 4137)
Direktiva 2014/32/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje mjernih instrumenata na tržištu (SL L 96, 29.3.2014., str. 149.).
Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 et RS 4 798), as last amended on 20 March 2008 (RO 2008 3437)
Direktiva 2014/33/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na dizala i sigurnosne komponente za dizala (SL L 96, 29.3.2014., str. 251.).
Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2011 (RO 2012 6235)
Direktiva 2014/28/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje eksploziva za civilnu upotrebu na tržištu i nadzoru nad njima (SL L 96, 29.3.2014., str. 1.).
Federal law of 22 March 1991 on radiation protection (RO 1994 1933), as last amended on 10 December 2004 (RO 2004 5391)
U Prilogu 1.
Ordinance of 17 October 2001 on medical devices (RO 2001 3487), as last amended on 15 April 2015 (RO 2015 999)
Proizvodni sektori poglavlje 4.
Ordinance of 18 April 2007 on import, transit and export of animals and animal products (RO 2007 1847), as last amended on 4 September 2013 (RO 2013 3041)
Medicinski proizvodi treba izbrisati i zamijeniti sljedećim:
Ordinance of 17 June 1996 on Accreditation and Designation of Conformity Assessment Bodies (RO 1996 1904), as last amended on 15 June 2012 (RO 2012 3631)
„POGLAVLJE 4.
Federal Act on Data Protection of 19 June 1992 (RO 1992 1945), as last amended on 30 September 2011 (RO 2013 3215)
MEDICINSKI PROIZVODI
SECTION II
ODJELJAK I.
Conformity assessment bodies
Zakoni i drugi propisi
The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.
Odredbe obuhvaćene člankom 1. stavkom 2.
SECTION III
Europska unija
Designating authorities
Direktiva Vijeća 90/385/EEZ od 20. lipnja 1990. o usklađivanju zakonodavstva država članica koji se odnose na aktivne medicinske proizvode za ugradnju, kako je zadnje izmijenjena Uredbom (EZ) br.