natgillin/translations-raw huggingface dataset:
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 (EU) 2016/426 Europskog parlamenta i Vijeća od 9. ožujka 2016. o aparatima na plinovita goriva i stavljanju izvan snage Direktive 2009/142/EZ (SL L 81, 31.3.2016., str. 99.).
SECTION II
Uredba (EU) 2016/424 Europskog parlamenta i Vijeća od 9. ožujka 2016. o žičarama i stavljanju izvan snage Direktive 2000/9/EZ (SL L 81, 31.3.2016., str. 1.).
Conformity assessment bodies
DODATAK A
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.
U Prilogu 1.
SECTION III
Proizvodni sektori, poglavlje 2.
Designating authorities
Oprema za osobnu zaštitu trebalo bi izbrisati i zamijeniti sljedećim, koje stupa na snagu 21. travnja 2018., kada Uredba (EU) 2016/425 i odgovarajuće švicarsko zakonodavstvo postanu primjenjivi, osim odjeljka IV., koji stupa na snagu istoga dana kao i ova Odluka:
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.
„POGLAVLJE 2.
SECTION IV
OPREMA ZA OSOBNU ZAŠTITU
Special rules relating to the designation of conformity assessment bodies
ODJELJAK I.
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 V of Regulation (EU) 2016/425.
Zakoni i drugi propisi
SECTION V
Odredbe obuhvaćene člankom 1. stavkom 2.
Supplementary provisions
Europska unija
Economic operators
Uredba (EU) 2016/425 Europskog parlamenta i Vijeća od 9. ožujka 2016. o osobnoj zaštitnoj opremi i o stavljanju izvan snage Direktive Vijeća 89/686/EEZ (SL L 81, 31.3.2016., str. 51.)
Specific obligations of economic operators pursuant to the legislation under Section I
Švicarska
Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.
Savezni zakon od 12. lipnja 2009. o sigurnosti proizvoda (RO 2010.
In order to avoid unnecessary duplication of obligations:
2573)
for the purpose of the obligations in Articles 8(6) and 10(3) of Regulation (EU) 2016/425 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.
Pravilnik od 19. svibnja 2010. o sigurnosti proizvoda (RO 2010.
In case 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;
2583), kako je zadnje izmijenjen 25. listopada 2017.
for the purpose of the obligations in Article 8(3) and 10(8) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keeps the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market in either the European Union or Switzerland.
(RO 2017.
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 keeps a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensures that the technical documentation can be made available to those authorities upon request for 10 years after the PPE has been placed on the market in either the European Union or Switzerland;
5865)
for the purpose of the obligations in Article 8(4), second subparagraph, and 10(6) of Regulation (EU) 2016/425 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.
Pravilnik od 25. listopada 2017. o sigurnosti osobne zaštitne opreme (RO 2017.
Authorised representative
5859)
For the purpose of the obligation in Article 9(2) of Regulation (EU) 2016/425 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 9(1) of Regulation (EU) 2016/425 or the corresponding Swiss provisions.
Pravilnik od 17. lipnja 1996. o švicarskom sustavu akreditacije i imenovanju ispitnih laboratorija i tijela za ocjenjivanje usklađenosti (RO 1996.
Cooperation with market surveillance authorities
1904), kako je zadnje izmijenjen 25. studenoga 2015.
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 PPE with the legislation in section I.
(RO 2016.
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.
261)
It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority.
ODJELJAK II.
It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the PPE.
Tijela za ocjenjivanje sukladnosti
Exchange of experience
Odbor osnovan člankom 10. ovog Sporazuma izrađuje i ažurira, u skladu s postupkom iz članka 11.
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 35 of Regulation (EU) 2016/425.
Sporazuma, popis tijela za ocjenjivanje sukladnosti.
Coordination of conformity assessment bodies
ODJELJAK III.
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 36 of Regulation (EU) 2016/425, directly or by means of designated representatives.
Tijela nadležna za imenovanje
Mutual assistance of market surveillance authorities
Odbor osnovan člankom 10. ovog Sporazuma izrađuje i ažurira popis tijela nadležnih za imenovanje koja stranke prijave.
Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities.
ODJELJAK IV.
The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information.
Posebna pravila za imenovanje tijela za ocjenjivanje sukladnosti
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.
U pogledu imenovanja tijela za ocjenjivanje sukladnosti, tijela nadležna za imenovanje postupaju u skladu s općim načelima sadržanima u Prilogu 2. ovom Sporazumu i s kriterijima ocjenjivanja određenima u poglavlju V. Uredbe (EU) 2016/425.
Procedure for dealing with PPE presenting a risk not restricted to the national territory
ODJELJAK V.
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 PPE covered by this Chapter presents a risk to the health or safety of persons covered by the 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:
Dodatne odredbe
the results of the evaluation and of the actions which they have required the economic operator to take;
Gospodarski subjekti
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the PPE being made available on their national market, to withdraw the PPE from that market or to recall it.
Posebne obveze gospodarskih subjekata u skladu sa zakonodavstvom iz odjeljka I.
This information shall include all available details, in particular the data necessary for the identification of the non-compliant PPE, their origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
U skladu sa zakonodavstvom iz odjeljka I. gospodarski subjekti s poslovnim nastanom u EU-u ili Švicarskoj podliježu jednakovrijednim obvezama.
In particular, it shall be indicated whether the non-compliance is due to either:
Kako bi se izbjeglo nepotrebno udvostručivanje obveza:
failure of the PPE to meet requirements relating to the health or safety of persons referred to in the legislation in section I, or
za potrebe obveza iz članka 8. stavka 6. i članka 10. stavka 3.
shortcomings in the harmonised standards referred to in the legislation in Section I.
Uredbe (EU) 2016/425 i odgovarajućih švicarskih odredaba, dovoljno je navesti ime, registrirano trgovačko ime ili registrirani žig i poštansku adresu na kojoj je dostupan proizvođač s poslovnim nastanom na državnom području Europske unije ili Švicarske.
Switzerland or Member States 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 PPE concerned.
Ako proizvođač nema poslovni nastan na državnom području Europske unije ili Švicarske, dovoljno je navesti ime, registrirano trgovačko ime ili registrirani žig i poštansku adresu na kojoj je dostupan uvoznik s poslovnim nastanom na državnom području Europske unije ili Švicarske;
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the PPE concerned, such as withdrawal of the PPE from their market, without delay.
za potrebe obveza iz članka 8. stavka 3. i članka 10. stavka 8.
Safeguard procedure in case of objections against national measures
Uredbe (EU) 2016/425 i odgovarajućih švicarskih odredaba, dovoljno je da proizvođač s poslovnim nastanom na državnom području Europske unije ili Švicarske sačuva tehničku dokumentaciju i izjavu EU-a o sukladnosti 10 godina nakon što je oprema za osobnu zaštitu stavljena na tržište u Europskoj uniji ili Švicarskoj.
Should Switzerland or a Member State disagree with the national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.
Ako proizvođač nema poslovni nastan na državnom području Europske unije ili Švicarske, dovoljno je da uvoznik s poslovnim nastanom na državnom području Europske unije ili Švicarske sačuva primjerak izjave EU-a o sukladnosti kako bi bila na raspolaganju tijelima za nadzor tržišta i da tim tijelima može na zahtjev dostaviti tehničku dokumentaciju 10 godina nakon što je oprema za osobnu zaštitu stavljena na tržište u Europskoj uniji ili Švicarskoj;
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, Switzerland, and via the Swiss authorities the relevant economic operator or operators.
za potrebe obveza iz članka 8. stavka 4. drugog podstavka i članka 10. stavka 6.
It shall evaluate the national measure, in order to determine whether the national measure is justified or not.
Uredbe (EU) 2016/425 i odgovarajućih švicarskih odredaba, dovoljno je da te obveze ispuni proizvođač s poslovnim nastanom na državnom području Europske unije ili Švicarske ili, ako taj proizvođač nema poslovni nastan na državnom području Europske unije ili Švicarske, uvoznik s poslovnim nastanom na državnom području Europske unije ili Švicarske.
If the national measure is considered:
Ovlašteni predstavnik
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant PPE is withdrawn from their markets, and shall inform the Commission accordingly;
Za potrebe obveze iz članka 9. stavka 2.
unjustified, the Member State concerned or Switzerland shall withdraw that measure.
Uredbe (EU) 2016/425 i odgovarajućih švicarskih odredaba, ovlašteni predstavnik je svaka fizička ili pravna osoba s poslovnim nastanom u Europskoj uniji ili Švicarskoj koju je proizvođač pismeno ovlastio da djeluje u njegovo ime u skladu s člankom 9. stavkom 1.
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.
Uredbe (EU) 2016/425 ili odgovarajućim švicarskim odredbama.
Compliant PPE which nevertheless present a risk
Suradnja s tijelima za nadzor tržišta
Where a Member State or Switzerland finds that, although a PPE 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, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
Nadležno tijelo za nadzor tržišta države članice Europske unije ili Švicarske može, na temelju obrazloženog zahtjeva, tražiti od relevantnih gospodarskih subjekata u Europskoj uniji i Švicarskoj da dostave sve informacije i dokumentaciju koji su potrebni za dokazivanje sukladnosti opreme za osobnu zaštitu sa zakonodavstvom iz odjeljka I.
That information shall include all available details, in particular the data necessary for the identification of the PPE concerned, the origin and the supply chain of the PPE, the nature of the risk involved and the nature and duration of the national measures taken.
Nadležno tijelo može se obratiti gospodarskom subjektu s poslovnim nastanom na državnom teritoriju druge stranke izravno ili uz pomoć nadležnog tijela za nadzor tržišta druge stranke.
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.
Od proizvođača ili, prema potrebi, od ovlaštenih predstavnika i uvoznika može tražiti da dostave dokumentaciju na jeziku koji to nadležno tijelo razumije.
Safeguard clause in case of remaining disagreement between the Parties
Od gospodarskih subjekata može zatražiti da surađuju u mjerama za uklanjanje rizika koje predstavlja oprema za osobnu zaštitu.
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 established under Article 10 of this Agreement, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.
Razmjena iskustava
Where the Committee considers that the measure is:
Švicarska tijela za imenovanje mogu sudjelovati u razmjeni iskustava među nadležnim tijelima država članica kako je navedeno u članku 35.
justified, the Parties shall take the measures necessary to ensure that the PPE is withdrawn from their market;
Uredbe (EU) 2016/425.
unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.’
Koordinacija tijela za ocjenjivanje sukladnosti
ATTACHMENT B
Švicarska imenovana tijela za ocjenjivanje sukladnosti mogu sudjelovati u mehanizmima koordinacije i suradnje predviđenima u članku 36.
In Annex 1, Product Sectors, Chapter 4, Medical Devices should be deleted and replaced by the following one:
Uredbe (EU) 2016/425, izravno ili preko imenovanih predstavnika.
‘CHAPTER 4
Uzajamna pomoć tijela za nadzor tržišta
MEDICAL DEVICES
U skladu s člankom 9. stavkom 1.
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. 1).
Sporazuma stranke osiguravaju učinkovitu suradnju i razmjenu informacija između svojih tijela za nadzor tržišta.
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. 1)
Tijela za nadzor tržišta država članica i Švicarske surađuju i razmjenjuju informacije.
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. 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. 1) and corrected by Corrigenda (OJ L 22, 29.1.1999, p. 75 and OJ L 6, 10.1.2002, p. 70).
Ta si tijela uzajamno pružaju primjerenu pomoć davanjem informacija ili dokumentacije o gospodarskim subjektima sa sjedištem u državi članici ili Švicarskoj.
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. 17).
Postupanje s opremom za osobnu zaštitu koja predstavlja rizik koji nije ograničen na državno područje
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. 43).
U skladu s člankom 12. stavkom 4. ovog Sporazuma, ako su tijela za nadzor tržišta države članice ili Švicarske poduzela mjere ili ako imaju dostatan razlog vjerovati da oprema za osobnu zaštitu obuhvaćena ovim poglavljem predstavlja rizik za zdravlje ili sigurnost osoba obuhvaćenih zakonodavstvom iz odjeljka I. ovog poglavlja i ako smatraju da nesukladnost nije ograničena na njihovo državno područje, bez odlaganja obavješćuju Europsku komisiju, ostale države članice i Švicarsku o sljedećem:
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 22, 9.8.2012, p. 3).
o rezultatima ocjenjivanja i o mjerama koje zahtijevaju od gospodarskog subjekta,
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. 41).
ako relevantni gospodarski subjekt ne poduzme odgovarajuće korektivne mjere, o svim prikladnim privremenim mjerama poduzetima kako bi se zabranila ili ograničila dostupnost opreme za osobnu zaštitu na njihovu nacionalnom tržištu te kako bi se ta oprema za osobnu zaštitu povukla ili opozvala s tržišta.
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. 98).
Te informacije uključuju sve dostupne podatke, a posebno one potrebne za identifikaciju nesukladne opreme za osobnu zaštitu, njezina podrijetla, vrste navodne nesukladnosti i s tim povezanih rizika, vrste i trajanja poduzetih nacionalnih mjera te obrazloženje relevantnoga gospodarskog subjekta.
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. 21).
Konkretno, navodi se je li uzrok nesukladnosti:
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. 63).
činjenica da oprema za osobnu zaštitu ne udovoljava propisima o zdravlju ili sigurnosti osoba navedenima u zakonodavstvu iz odjeljka I. ili
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. 50).
nedostaci u usklađenim normama navedenima u zakonodavstvu iz odjeljka I.
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. 88).
Švicarska ili države članice bez odlaganja obavješćuju Europsku komisiju i ostala nacionalna tijela o svim donesenim mjerama te o svim dodatnim informacijama koje su im na raspolaganju u vezi s nesukladnošću predmetne opreme za osobnu zaštitu.
Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45).
Države članice i Švicarska bez odlaganja osiguravaju provedbu odgovarajućih mjera ograničavanja u pogledu predmetne opreme za osobnu zaštitu, kao što je povlačenje opreme za osobnu zaštitu sa svojih tržišta.
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. 28).
Zaštitni postupak u slučaju prigovora na nacionalne mjere
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. 8).
Ako se Švicarska ili država članica ne slažu s nacionalnom mjerom iz stavka 5., one u roku od tri mjeseca od primitka te informacije o svojim prigovorima obavješćuju Europsku komisiju.
Chapter IV and Annex VII of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Ako po završetku postupka iz stavka 5. država članica ili Švicarska podnesu prigovor na mjeru koju je poduzela Švicarska ili država članica, ili ako Komisija smatra da je nacionalna mjera protivna relevantnom zakonodavstvu navedenom u odjeljku I., Europska komisija bez odlaganja započinje savjetovanje s državama članicama, Švicarskom, i, posredstvom švicarskih tijela, s relevantnim gospodarskim subjektom ili subjektima.
Chapter IV and Annex VII of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
Komisija ocjenjuje nacionalnu mjeru da bi se utvrdilo je li opravdana.