natgillin/translations-raw huggingface dataset:
The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.
1882/2003 Europskog parlamenta i Vijeća od 29. rujna 2003.
SECTION IV
(SL L 284, 31.10.2003., str.
Special rules relating to the designation of conformity assessment bodies
1.)
For the designation of conformity assessment bodies under this Chapter, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and, as laid down in Implementing Regulation (EU) No 920/2013, the assessment criteria set out in Annex XI to Directive 93/42/EEC, in Annex 8 to Directive 90/385/EEC and in Annex IX to Directive 98/79/EC.
Direktiva Vijeća 93/42/EEZ od 14. lipnja 1993. o medicinskim proizvodima, kako je zadnje izmijenjena Uredbom (EZ) br.
Switzerland shall make available assessors for the pool established under Implementing Regulation (EU) No 920/2013.
1882/2003 Europskog parlamenta i Vijeća od 29. rujna 2003.
SECTION V
(SL L 284, 31.10.2003., str.
Supplementary provisions
1.)
Registration of the person responsible for placing devices on the market
Direktiva 98/79/EZ Europskog parlamenta i Vijeća od 27. listopada 1998. o in vitro dijagnostičkim medicinskim proizvodima (SL L 331, 7.12.1998., str.
Any manufacturer or his authorised representative who places on the market of one of the Parties the medical devices referred to in Article 14 of Directive 93/42/EEC or Article 10 of Directive 98/79/EC shall inform the competent authorities of the Party in which he has his registered place of business of the particulars referred to in those Articles.
1.), kako je zadnje izmijenjena Uredbom (EZ) br.
The Parties shall reciprocally recognise that registration.
1882/2003 Europskog parlamenta i Vijeća od 29. rujna 2003.
The manufacturer shall not be obliged to designate a person responsible for placing devices on the market established in the territory of the other Party.
(SL L 284, 31.10.2003., str.
Labelling of medical devices
1.) i ispravljena ispravcima (SL L 22, 29.1.1999., str.
Manufacturers of both Parties shall indicate their name or trade name and address on the label of medical devices specified in Annex 1, point 13.3(a) to Directive 93/42/EEC and in vitro diagnostic medical devices specified in Annex 1, point 8.4(a), to Directive 98/79/EC.
75. i SL L 6, 10.1.2002., str.
They shall not be obliged to indicate the name and address of the person responsible for placing the device on the market, of the representative or of the importer established within the territory of the other Party on the label, outer packaging or instructions for use.
70.)
For devices imported from third countries, in view of their distribution in the Union and Switzerland, the label, or the outer packaging, or instructions for use, shall contain the name and address of the single authorised representative of the manufacturer established within the Union or Switzerland, as appropriate.
4.
Information exchange
Odluka Komisije 2002/364/EZ od 7. svibnja 2002. o zajedničkim tehničkim specifikacijama za in vitro dijagnostičke medicinske proizvode (SL L 131, 16.5.2002., str.
In accordance with Article 9 of the Agreement, the Parties shall in particular exchange the information referred to in Article 8 of Directive 90/385/EEC, Article 10 of Directive 93/42/EEC, Article 11 of Directive 98/79/EC and Article 3 of Implementing Regulation (EU) No 920/2013.
17.).
European databases
Direktiva Komisije 2003/12/EZ od 3. veljače 2003. o ponovnoj klasifikaciji implantata za dojke u okviru Direktive 93/42/EEZ u pogledu medicinskih proizvoda (SL L 28, 4.2.2003., str.
The competent Swiss authorities shall have access to the European databases established under Article 12 of Directive 98/79/EC, Article 14a of Directive 93/42/EEC and Article 3 of Implementing Regulation (EU) No 920/2013.
43).
They shall transmit to the Commission and/or body responsible for managing the databases the data provided for in those Articles collected in Switzerland for entry into the European databases.’
Uredba Komisije (EU) br.
ATTACHMENT B
722/2012 od 8. kolovoza 2012. o posebnim zahtjevima u vezi sa zahtjevima utvrđenim u direktivama Vijeća 90/385/EEZ i 93/42/EEZ s obzirom na aktivne medicinske proizvode za ugradnju i medicinske proizvode proizvedene korištenjem tkiva životinjskog podrijetla (SL L 212, 9.8.2012., str.
In Annex 1, Product Sectors, Chapter 6, Pressure vessels should be deleted and replaced by the following one:
3.)
‘CHAPTER 6
Direktiva Komisije 2005/50/EZ od 11. kolovoza 2005. o ponovnoj kategorizaciji zglobnih proteza kuka, koljena i ramena u okviru Direktive 93/42/EEZ o medicinskim proizvodima (SL L 210, 12.8.2005., str.
PRESSURE VESSELS
41.)
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.
Uredba Komisije (EZ) br.
45)
2007/2006 od 22. prosinca 2006. o provedbi Uredbe (EZ) br. 1774/2002 Europskog parlamenta i Vijeća s obzirom na uvoz i provoz određenih međuproizvoda dobivenih od materijala kategorije 3. namijenjenih za tehničku upotrebu u medicinskim proizvodima, in vitro dijagnostici i laboratorijskim reagensima te o izmjeni te Uredbe (SL L 379, 28.12.2006., str.
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.
98.)
164)
Direktiva 2007/47/EZ Europskog parlamenta i Vijeća od 5. rujna 2007. o izmjeni Direktive Vijeća 90/385/EEZ o usklađivanju zakonodavstava država članica u odnosu na aktivne medicinske proizvode za ugradnju, Direktive Vijeća 93/42/EEZ o medicinskim proizvodima i Direktive 98/8/EZ o stavljanju biocidnih pripravaka na tržište (SL L 247, 21.9.2007., str.
Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p.
21.)
1), hereinafter referred to as “Directive 2010/35/EU”
10.
Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p.
Odluka Komisije 2011/869/EU od 20. prosinca 2011. o izmjeni Odluke 2002/364/EZ o zajedničkim tehničkim specifikacijama za in vitro dijagnostičke medicinske proizvode (SL L 341, 22.12.2011., str.
13)
63.)
Federal Law of 12 June 2009 on product safety (RO 2010 2573)
Direktiva Komisije 2011/100/EU od 20. prosinca 2011. o izmjeni Direktive 98/79/EZ Europskog parlamenta i Vijeća o in vitro dijagnostičkim medicinskim proizvodima (SL L 341, 22.12.2011., str.
Ordinance of 19 May 2010 on product safety (RO 2010 2583), as last amended on 15 June 2012 (RO 2012 3631)
50.)
Ordinance of 25 November 2015 on the safety of simple pressure vessels (RO 2016 227)
Direktiva 2011/65/EU Europskog parlamenta i Vijeća od 8. lipnja 2011. o ograničenju uporabe određenih opasnih tvari u električnoj i elektroničkoj opremi (SL L 174, 1.7.2011., str.
Ordinance of 25 November 2015 on the safety of pressure equipment (RO 2016 233)
88.)
Ordinance of 31 October 2012 relating to the placing on the market of dangerous goods receptacles and the market surveillance (RO 2012 6607)
13.
Ordinance of 29 November 2002 on the transport of dangerous goods by road (RO 2002 4212), as last amended on 31 October 2012 (RO 2012 6535 and 6537)
Odluka Komisije 2010/227/EU od 19. travnja 2010. o Europskoj bazi podataka za medicinske proizvode (Eudamed) (SL L 102, 23.4.2010., str.
Ordinance of 31 October 2012 on the transport of dangerous goods by rail and cableway (RO 2012 6541)
45.)
Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 25 November 2015 (RO 2016 261)
Uredba Komisije (EU) br.
For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter 4 of Directive 2014/29/EU, Chapter 4 of Directive 2014/68/EU or Chapter 4 of Directive 2010/35/EU.
207/2012 od 9. ožujka 2012. o elektronskim uputama za uporabu medicinskih proizvoda (SL L 72, 10.3.2012., str.
Economic operators
28).
Specific obligations of economic operators pursuant to the legislation under Section I
Provedbena uredba Komisije (EU) br.
Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.
920/2013 оd 24. rujna 2013. o imenovanju i nadziranju prijavljenih tijela na temelju Direktive Vijeća 90/385/EEZ o aktivnim medicinskim proizvodima za ugradnju i Direktive Vijeća 93/42/EEZ o medicinskim proizvodima (SL L 253, 25.9.2013., str.
In order to avoid unnecessary duplication of obligations:
8.)
for the purpose of the obligations in Article 6(3) of Directive 2010/35/EU, respectively Articles 6(6) and 8(3) of Directive 2014/29/EU, or Articles 6(6) and 8(3) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted.
Švicarska
In cases where the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted;
Savezni zakon od 15. prosinca 2000. o lijekovima i medicinskim proizvodima (RO 2001.
for the purpose of the obligations in Articles 4(3) and 6(6) of Directive 2010/35/EU, respectively Articles 6(3) and 8(8) of Directive 2014/29/EU or Articles 6(3) and 8(8) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the product has been placed on the market in either the European Union or Switzerland.
2790), kako je zadnje izmijenjen 1. siječnja 2014.
In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keep a copy of the EU declaration of conformity or, where applicable, the attestation of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request for 10 years after the product has been placed on the market in either the European Union or Switzerland;
(RO 2013.
for the purpose of the obligations in Articles 6(4), second subparagraph, and 8(6) of Directive 2014/29/EU or Articles 6(4), second subparagraph, and 8(6) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.
4137)
Authorised representative
Savezni zakon od 24. lipnja 1902. o električnim instalacijama sa slabom i jakom strujom (RO 19252 i RS 4798), kako je zadnje izmijenjen 20. ožujka 2008.
For the purpose of the obligation in Article 5(2) of Directive 2010/35/EU, respectively Article 7(2) of Directive 2014/29/EU, or Article 7(2) of Directive 2014/68/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 5(1) of Directive 2010/35/EU, respectively Article 7(1) of Directive 2014/29/EU, or Article 7(1) of Directive 2014/68/EU or the corresponding Swiss provisions.
(RO 2008.
Cooperation with market surveillance authorities
3437)
The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a product with the legislation in Section I.
Savezni zakon od 9. lipnja 1977. o mjeriteljstvu (RO 1977.
That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party.
2394), kako je zadnje izmijenjen 17. lipnja 2011.
It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority.
(RO 2012.
It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the product.
6235)
Exchange of experience
Savezni zakon od 22. ožujka 1991. o zaštiti od zračenja (RO 1994.
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 28 of Directive 2010/35/EU, Article 32 of Directive 2014/29/EU and Article 37 of Directive 2014/68/EU.
1933), kako je zadnje izmijenjen 10. prosinca 2004.
Coordination of conformity assessment bodies
(RO 2004.
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 29 of Directive 2010/35/EU, Article 33 of Directive 2014/29/EU and Article 38 of Directive 2014/68/EU, directly or by means of designated representatives.
5391)
Mutual assistance of market surveillance authorities
Pravilnik od 17. listopada 2001. o medicinskim proizvodima (RO 2001.
Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities.
3487), kako je zadnje izmijenjen 15. travnja 2015.
The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information.
(RO 2015.
They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.
999)
Procedure for dealing with products presenting a risk not restricted to the national territory
Pravilnik od 18. travnja 2007. o uvozu, provozu i izvozu životinja i životinjskih proizvoda (RO 2007.
Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a product covered by this chapter presents a risk to the health or safety of persons or to other aspects of public interest protection referred to in the relevant legislation in Section I of this Chapter and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:
1847), kako je zadnje izmijenjen 4. rujna 2013.
the results of the evaluation and of the actions which they have required the economic operator to take,
(RO 2013.
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the product being made available on their national market, to withdraw the product from that market or to recall it.
3041)
This information shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
Pravilnik od 17. lipnja 1996. o akreditaciji i imenovanju tijela za ocjenjivanje sukladnosti (RO 1996.
In particular, it shall be indicated whether the non-compliance is due to either:
1904), kako je zadnje izmijenjen 15. lipnja 2012.
failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection in the legislation in Section I, or
(RO 2012.
shortcomings in the harmonised standards referred to in the legislation in Section I.
3631)
Switzerland or Member States other than the Member State initiating the procedure shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned.
Savezni zakon o zaštiti podataka od 19. lipnja 1992.
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.
(RO 1992.
Safeguard procedure in case of objections against national measures
1945), kako je zadnje izmijenjen 30. rujna 2011.
Should it disagree with the notified national measure in paragraph 5, Switzerland or a Member State shall inform the European Commission of its objections within three months of the receipt of the information.
ODJELJAK II.
Where, on completion of the procedure set out in paragraph 5, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States and Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measure, in order to determine whether the national measure is justified or not.
Tijela za ocjenjivanje sukladnosti
If the national measure is considered:
Odbor osnovan člankom 10. ovog Sporazuma izrađuje i ažurira, u skladu s postupkom iz članka 11.
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant product is withdrawn from their markets, and shall inform the Commission accordingly,
Sporazuma, popis tijela za ocjenjivanje sukladnosti.
unjustified, the Member State concerned or Switzerland shall withdraw that measure.
ODJELJAK III.
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.
Tijela nadležna za imenovanje
Compliant products which nevertheless present a risk
Odbor osnovan člankom 10. ovog Sporazuma izrađuje i ažurira popis tijela nadležnih za imenovanje koja su stranke prijavile.
Where a Member State or Switzerland finds that, although a product that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to other aspects of public interest protection referred to in the relevant legislation in Section I of this Chapter, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
ODJELJAK IV.
That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.
Posebna pravila za imenovanje tijela za ocjenjivanje sukladnosti
The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary propose appropriate measures.
Za imenovanje tijela za ocjenjivanje sukladnosti u okviru ovog poglavlja, tijela nadležna za imenovanje pridržavaju se općih načela iz Priloga 2. ovom Sporazumu, kako je propisano u Provedbenoj uredbi (EU) br.
Safeguard clause in case of remaining disagreement between the Parties
920/2013, kriterija ocjenjivanja utvrđenih u Prilogu XI.
In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.
Direktivi 93/42/EEZ, Prilogu 8.
Where the Committee considers that the measure is:
Direktivi 90/385/EEZ ili u Prilogu IX.
justified, the Parties shall take the measures necessary to ensure that the product is withdrawn from their market;
Direktivi 98/79/EZ.
unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.’
Švicarska stavlja na raspolaganje skupinu ocjenjivača uspostavljenu u skladu s Provedbenom uredbom (EU) br. 920/2013.
ATTACHMENT C
ODJELJAK V.
In Annex 1, Product Sectors, Chapter 7, Radio equipment and telecommunications terminal equipment should be deleted and replaced by the following one:
Dodatne odredbe
‘CHAPTER 7
Registracija osobe nadležne za stavljanje medicinskih proizvoda na tržište
RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT
Svaki proizvođač ili njegov ovlašteni predstavnik koji stavlja na tržište jedne od stranaka medicinske proizvode iz članka 14.
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the 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.
Direktive 93/42/EEZ ili članka 10.
62)
Direktive 98/79/EZ obavješćuje nadležna tijela stranke u kojoj je registriran o pojedinostima iz tih članaka.
Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p.
Stranke uzajamno priznaju tu registraciju.
13) [1]
Proizvođač nije dužan odrediti osobu nadležnu za stavljanje proizvoda na uvedeno tržište na državnom području druge stranke.
Commission Decision 2000/637/EC of 22 September 2000 on the application of Article 3(3)(e) of Directive 1999/5/EC to radio equipment covered by the regional arrangement concerning radiotelephone service on inland waterways (OJ L 269, 21.10.2000, p. 50)
Označivanje medicinskih proizvoda
Commission Decision 2001/148/EC of 21 February 2001 on the application of Article 3(3)(e) of Directive 1999/5/EC to avalanche beacons (OJ L 55, 24.2.2001, p. 65)
Proizvođači obiju stranaka navode svoje ime ili trgovačko ime i adresu na oznaci medicinskih proizvoda kako je određeno u točki 13.3. podtočki (a) Priloga 1.
Commission Decision 2005/53/EC of 25 January 2005 on the application of Article 3(3)(e) of Directive 1999/5/EC of the European Parliament and of the Council to radio equipment intended to participate in the Automatic Identification System (AIS) (OJ L 22, 26.1.2005, p. 14)
Direktivi 93/42/EEZ i in vitro dijagnostičkih medicinskih proizvoda kako je određeno u točki 8.4. podtočki (a) Priloga 1.
Commission Decision 2005/631/EC of 29 August 2005 concerning essential requirements as referred to in Directive 1999/5/EC of the European Parliament and of the Council ensuring access of Cospas-Sarsat locator beacons to emergency services (OJ L 225, 31.8.2005, p.
Direktivi 98/79/EZ.
28)
Oni nisu dužni na oznaci, vanjskom pakiranju ili uputama za upotrebu navesti ime i adresu osobe nadležne za stavljanje proizvoda na tržište, predstavnika ili uvoznika s poslovnim nastanom na državnom području druge stranke.