natgillin/translations-raw huggingface dataset:
detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure compliance with the criteria referred to in paragraph 4 of this Article.
osigurati znanstvenu i tehničku podršku Komisiji, MDCG-u, državama članicama i prijavljenim tijelima u odnosu na provedbu ove Uredbe;
the structure and the level of the fees referred to in paragraph 7 of this Article which may be levied by an EU reference laboratory for providing scientific opinions in response to consultations by notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human health and safety protection, support of innovation and cost-effectiveness.
pružiti znanstvene savjete u vezi s najnovijim dostignućima u pogledu posebnih proizvoda ili kategorije ili skupine proizvoda;
The EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation.
uspostaviti mrežu nacionalnih referentnih laboratorija nakon savjetovanja s nacionalnim tijelima i njome upravljati te objaviti popis sudjelujućih nacionalnih referentnih laboratorija i njihovih pojedinačnih zadaća;
If those controls find that an EU reference laboratory is not complying with the requirements for which it has been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the designation.
doprinijeti razvoju odgovarajućih metoda testiranja i analize koje se primjenjuju za postupke ocjenjivanja sukladnosti i nadzor tržišta;
The provisions in Article 107(1) of Regulation (EU) 2017/745 shall apply to the staff of the EU reference laboratories.
surađivati s prijavljenim tijelima u pogledu razvoja najboljih praksi za provođenje postupaka ocjenjivanja sukladnosti;
Article 101
osigurati preporuke o prikladnim referentnim materijalima i referentnim postupcima mjerenja višeg metrološkog reda;
Device registers and databanks
doprinositi razvoju zajedničkih specifikacija i međunarodnih standarda;
The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information.
osigurati znanstvena mišljenja kao odgovor na savjetovanja s prijavljenim tijelima u skladu s ovom Uredbom i objaviti ih elektroničkim putem nakon razmatranja nacionalnih odredaba o povjerljivosti.
Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices.
Na zahtjev države članice Komisija također može imenovati referentne laboratorije EU-a kada se ta država članica želi poslužiti takvim laboratorijima kako bi osigurala provjeru učinkovitosti koju navodi proizvođač i usklađenosti proizvodâ klase C s primjenjivim zajedničkim specifikacijama kada su dostupne ili s drugim rješenjima koje odabere proizvođač kako bi osigurao razinu sigurnosti i učinkovitosti koja je barem istovjetna.
CHAPTER IX
Referentni laboratoriji EU-a zadovoljavaju sljedeće kriterije:
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
imaju odgovarajuće i prikladno kvalificirano osoblje s odgovarajućim znanjem i iskustvom u području in vitro dijagnostičkih medicinskih proizvoda za koje su imenovani;
Article 102
raspolažu opremom i referentnim materijalom koji su potrebni za obavljanje zadaća koje su im dodijeljene;
Confidentiality
imaju potrebno znanje o međunarodnim normama i najboljoj praksi;
Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:
imaju odgovarajuću upravnu organizaciju i strukturu;
personal data in accordance with Article 103;
osiguravaju da njihovo osoblje poštuje povjerljivost informacija i podataka koje je prikupilo pri obavljanju svojih zadaća;
commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights unless disclosure is in the public interest;
djeluju u skladu s javnim interesom i neovisno;
the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.
osiguravaju da njihovo osoblje nema financijske ili druge interese u industriji in vitro dijagnostičkih medicinskih proizvoda koji bi mogli utjecati na njihovu nepristranost, da prijavi svaki drugi izravni i neizravni interes u industriji in vitro dijagnostičkih medicinskih proizvoda i ažurira tu izjavu kad god dođe do relevantne promjene.
Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities and between competent authorities and the Commission shall not be disclosed without the prior agreement of the originating authority.
Referentni laboratoriji EU-a uspostavljaju mrežu kako bi koordinirali i usklađivali svoje metode rada u pogledu testiranja i ocjenjivanja.
Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
To koordiniranje i usklađivanje uključuju:
The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
primjenu koordiniranih metoda, postupaka i procesa;
Article 103
dogovaranje o uporabi istih referentnih materijala, zajedničkih uzoraka za testiranje i serokonverzijskih panela;
Data protection
uspostavu zajedničkih kriterija za ocjenjivanje i tumačenje;
Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
primjenu zajedničkih protokola testiranja i ocjenjivanja rezultata testiranja primjenom standardiziranih i koordiniranih metoda procjene;
Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
primjenu standardiziranih i koordiniranih izvješća o testiranju;
Article 104
razvoj, primjenu i održavanje sustava istorazinske ocjene;
Levying of fees
organiziranje redovitih testiranja ocjene kvalitete (uključujući uzajamne provjere u vezi s kvalitetom i usporedivosti rezultata testiranja);
This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost-recovery principles.
dogovaranje o zajedničkim smjernicama, uputama, postupovnim uputama ili standardnim operativnim postupcima;
Member States shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted.
koordiniranje uvođenja metoda testiranja za nove tehnologije i u skladu s novim ili izmijenjenim zajedničkim specifikacijama;
The structure and level of fees shall be made publicly available on request.
ponovno ocjenjivanje najnovijih dostignuća na temelju rezultata usporednih testiranja ili daljnjih studija, na zahtjev države članice ili Komisije;
Article 105
Referentnim laboratorijima EU-a može se odobriti financijski doprinos Unije.
Funding of activities related to designation and monitoring of notified bodies
Komisija može provedbenim aktima utvrditi podrobne aranžmane i iznos financijskog doprinosa Unije referentnim laboratorijima EU-a, vodeći računa o ciljevima zaštite zdravlja i sigurnosti, potpore inovacijama i troškovne učinkovitosti.
The costs associated with joint assessment activities shall be covered by the Commission.
Kada prijavljena tijela ili države članice zatraže znanstvenu ili tehničku pomoć ili znanstveno mišljenje referentnog laboratorija EU-a, od njih se može zahtijevati da plate naknade kako bi se potpuno ili djelomično pokrili troškovi koje je taj laboratorij pretrpio pri provedbi zatražene zadaće u skladu s unaprijed utvrđenim i transparentnim odredbama i uvjetima.
The Commission shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other necessary implementing rules.
Komisija provedbenim aktima određuje:
Article 106
podrobna pravila za olakšavanje primjene stavka 2. ovog članka i podrobna pravila za osiguravanje usklađenosti s kriterijima iz stavka 4. ovog članka.
Penalties
strukturu i visinu naknada iz stavka 7. ovog članka koje referentni laboratorij EU-a može obračunati za pružanje znanstvenih mišljenja koja zatraže prijavljena tijela i države članice pri savjetovanju s njima u skladu s ovom Uredbom, vodeći računa o ciljevima zaštite ljudskog zdravlja i sigurnosti, potpori inovacijama i troškovnoj učinkovitosti.
The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
Referentni laboratoriji EU-a podliježu kontrolama Komisije radi provjere usklađenosti sa zahtjevima ove Uredbe, što uključuje posjete na licu mjesta i revizije.
The penalties provided for shall be effective, proportionate, and dissuasive.
Ako se tijekom tih nadzora utvrdi da referentni laboratorij EU-a ne ispunjava zahtjeve za koje je imenovan, Komisija provedbenim aktima poduzima odgovarajuće mjere, uključujući ograničavanje, suspenziju ili povlačenje imenovanja.
The Member States shall notify the Commission of those rules and of those measures by 25 February 2022 and shall notify it without delay of any subsequent amendment affecting them.
Odredbe iz članka 107. stavka 1.
CHAPTER X
Uredbe (EU) 2017/745 primjenjuju se na osoblje referentnih laboratorija EU-a.
FINAL PROVISIONS
Članak 101.
Article 107
Registri proizvoda i baze podataka
Committee procedure
Komisija i države članice poduzimaju sve odgovarajuće mjere kako bi potaknule uspostavu registara i baza podataka za posebne vrste proizvoda čime se utvrđuju zajednička načela za prikupljanje usporedivih informacija.
The Commission shall be assisted by the Committee on Medical Devices established by Article 114 of Regulation (EU) 2017/745.
Tim se registrima i bazama podataka doprinosi nezavisnoj procjeni dugoročne sigurnosti i učinkovitosti proizvodâ.
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011
POGLAVLJE IX.
Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
POVJERLJIVOST, ZAŠTITA PODATAKA, FINANCIRANJE I SANKCIJE
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Članak 102.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Povjerljivost
Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or 5 thereof, as appropriate, shall apply.
Osim ako je drugačije predviđeno u ovoj Uredbi i ne dovodeći u pitanje postojeće nacionalne odredbe i prakse u državama članicama o povjerljivosti, sve stranke koje su uključene u primjenu ove Uredbe poštuju povjerljivost informacija i podataka dobivenih pri obavljanju svojih zadaća radi zaštite:
Exercise of the delegation
komercijalno povjerljivih informacija i poslovnih tajni fizičke ili pravne osobe, uključujući prava intelektualnog vlasništva, osim ako je otkrivanje u javnom interesu;
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
učinkovite provedbe ove Uredbe, posebice za potrebe inspekcija, istraga ili revizija.
The power to adopt delegated acts referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall be conferred on the Commission for a period of five years from 25 May 2017.
Ne dovodeći u pitanje stavak 1., informacije koje na povjerljivoj osnovi međusobno razmjenjuju nadležna tijela te nadležna tijela i Komisija ne otkrivaju se bez prethodne suglasnosti izvornog tijela.
The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period.
Stavci 1. i 2. ne utječu na prava i obveze Komisije, država članica i prijavljenih tijela u pogledu razmjene informacija i širenja upozorenja niti na obveze dotičnih osoba da pruže informacije u skladu s kaznenim pravom.
The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Komisija i države članice mogu razmjenjivati povjerljive informacije s regulatornim tijelima trećih zemalja s kojima su sklopile bilateralne ili multilateralne sporazume o povjerljivosti.
The delegation of power referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) may be revoked at any time by the European Parliament or by the Council.
Članak 103.
A decision to revoke shall put an end to the delegation of the power specified in that decision.
Zaštita podataka
It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.
Države članice primjenjuju Direktivu 95/46/EZ na obradu osobnih podataka koja se provodi u državama članicama u skladu s ovom Uredbom.
It shall not affect the validity of any delegated acts already in force.
Uredba (EZ) br.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
45/2001 primjenjuje se na obradu osobnih podataka koju provodi Komisija u skladu s ovom Uredbom.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Članak 104.
A delegated act adopted pursuant to Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Zaračunavanje pristojbi
That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Ovom Uredbom ne dovodi se u pitanje mogućnost država članica da zaračunavaju pristojbe za aktivnosti utvrđene u ovoj Uredbi, pod uvjetom da je visina pristojbi određena transparentno i na osnovi načela naknade troškova.
Article 109
Države članice obavješćuju Komisiju i druge države članice o tomu najmanje tri mjeseca prije donošenja strukture i visine pristojbi.
Separate delegated acts for different delegated powers
Struktura i visina pristojbi objavljuju se na zahtjev.
The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation.
Članak 105.
Article 110
Financiranje aktivnosti u vezi s imenovanjem i praćenjem prijavljenih tijela
Transitional provisions
Komisija pokriva troškove u vezi s aktivnostima zajedničkog ocjenjivanja.
From 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void.
Komisija će provedbenim aktima utvrditi opseg i strukturu troškova za koje je moguć povrat i ostala potrebna provedbena pravila.
Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI to Directive 98/79/EC which shall become void at the latest on 27 May 2024.
Članak 106.
Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 shall become void by 27 May 2024.
Sankcije
By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with that Directive, and provided there are no significant changes in the design and intended purpose.
Države članice utvrđuju propise o sankcijama koje se primjenjuju na kršenje odredaba ove Uredbe i poduzimaju sve potrebne mjere radi osiguranja njihove provedbe.
Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all applicable requirements relating to the devices it has certified.
Države članice do 25. veljače 2022. obavješćuju Komisiju o tim pravilima i tim mjerama te je bez odgode obavješćuju o svim naknadnim izmjenama koje na njih utječu.
Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.
POGLAVLJE X.
By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before 26 May 2022.
ZAVRŠNE ODREDBE
By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2022.
Članak 107.
Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2022.
Postupak odbora
As regards devices subject to the procedures laid down in Article 48(3) and (4), paragraph 5 of this Article applies provided that the necessary appointments to the MDCG and expert panels and of EU reference laboratories have been made.
1.
By way of derogation from Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Article 27(3) and Article 28(1) and Article 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC as specified in Decision 2010/227/EU.
Komisiji pomaže Odbor za medicinske proizvode osnovan člankom 114.
Authorisations granted by the competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation.
Uredbe (EU) 2017/745.
Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.
Navedeni odbor jest odbor u smislu Uredbe (EU) br.
Article 111
182/2011.
Evaluation
Pri upućivanju na ovaj stavak primjenjuje se članak 4.
By 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation report on the progress towards achievement of the objectives contained herein including an assessment of the resources required to implement this Regulation.
Uredbe (EU) br.
Special attention shall be given to the traceability of devices through the storage, pursuant to Article 24, of the UDI by economic operators, health institutions and health professionals.
182/2011.
The evaluation shall also include a review on the functioning of Article 4.
Pri upućivanju na ovaj stavak primjenjuje se članak 5.
Article 112
Uredbe (EU) br.
Repeal
182/2011.
Without prejudice to Articles 110 (3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and the obligations of manufacturers as regards the making available of documentation, under Directive 98/79/EC, that Directive is repealed with effect from 26 May 2022 with the exception of:
Kada odbor ne dostavi nikakvo mišljenje, Komisija ne donosi nacrt provedbenog akta te se primjenjuje članak 5. stavak 4. treći podstavak Uredbe (EU) br. 182/2011.
Article 11, point (c) of Article 12(1) and Article 12(2) and (3) of Directive 98/79/EC, and the obligations relating to vigilance and performance studies provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation; and
Pri upućivanju na ovaj stavak primjenjuje se članak 8.
Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, and the obligations relating to registration of devices and economic operators, and certificate notifications provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation.
Uredbe (EU) br.
As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs.
182/2011 u vezi s njezinim člancima 4. ili 5., prema potrebi.
Decision 2010/227/EU adopted in implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC shall be repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation.
Članak 108.
References to the repealed Directive shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XV.
Izvršavanje delegiranja ovlasti
Article 113
Ovlast za donošenje delegiranih akata dodjeljuje se Komisiji podložno uvjetima utvrđenima ovim člankom.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
3.
It shall apply from 26 May 2022.
Europski parlament ili Vijeće može u svakom trenutku opozvati delegirane ovlasti iz članka 10. stavka 4., članka 17. stavka 4., članka 24. stavka 10., članka 51. stavka 6. i članka 66. stavka 8.
Article 27(3) and Article 51(5) shall apply from 27 November 2023;
Opoziv počinje proizvoditi učinke sljedećeg dana od dana objave spomenute odluke u Službenom listu Europske unije ili na kasniji datum naveden u spomenutoj odluci.
Articles 31 to 46 and Article 96 shall apply from 26 November 2017.
On ne utječe na valjanost delegiranih akata koji su već na snazi.
However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34;
Prije donošenja delegiranog akta Komisija se savjetuje sa stručnjacima koje je imenovala svaka država članica u skladu s načelima utvrđenima u Međuinstitucijskom sporazumu od 13. travnja 2016. o boljoj izradi zakonodavstva.
Article 97 shall apply from 26 May 2018;
Čim donese delegirani akt, Komisija ga istodobno priopćuje Europskom parlamentu i Vijeću.
Article 100 shall apply from 25 November 2020;
Delegirani akt donesen u skladu s člankom 10. stavkom 4., člankom 17. stavkom 4., člankom 24. stavkom 10., člankom 51. stavkom 6. i člankom 66. stavkom 8. stupa na snagu samo ako Europski parlament ili Vijeće ne uputi prigovor na taj akt u roku od tri mjeseca od podnošenja obavijesti Europskom parlamentu i Vijeću o njemu ili ako su prije isteka tog roka i Europski parlament i Vijeće izvijestili Komisiju da neće podnijeti prigovor.