natgillin/translations-raw huggingface dataset:
The structure and the level of fees as well as the scale and structure of recoverable costs shall be adopted by the Commission by means of implementing acts, taking into account the objectives of the adequate implementation of this Regulation, protection of health and safety, support of innovation and cost-effectiveness and the necessity to achieve active participation in the expert panels.
Pristojbe koje se plaćaju Komisiji u skladu s postupkom iz ovog članka stavka 13. utvrđuju se na transparentan način i na temelju troškova za pružene usluge.
The fees payable to the Commission in accordance with the procedure under paragraph 13 of this Article shall be set in a transparent manner and on the basis of the costs for the services provided.
Pristojbe koje se plaćaju smanjuju se ako je postupak savjetovanja u pogledu kliničke procjene započet u skladu s Prilogom IX. odjeljkom 5.1. točkom (c) i uključuje proizvođača koji je mikropoduzeće, malo ili srednje poduzeće u smislu Preporuke 2003/361/EZ.
The fees payable shall be reduced in the case of a clinical evaluation consultation procedure initiated in accordance with point (c) of Section 5.1 of Annex IX involving a manufacturer who is a micro, small or medium-sized enterprise within the meaning of Recommendation 2003/361/EC.
Komisija je ovlaštena donositi delegirane akte u skladu s člankom 115. radi izmjene zadaća stručnih skupina i stručnih laboratorija iz stavka 10.ovog članka.
The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the tasks of expert panels and expert laboratories referred to in paragraph 10 of this Article.
Članak 107.
Article 107
Sukob interesa
Conflict of interests
Članovi MDCG-a, njegovih podskupina i članovi stručnih skupina i stručnih laboratorija ne smiju imati financijske ili druge interese u industriji medicinskih proizvoda koji bi mogli utjecati na njihovu nepristranost.
Members of the MDCG, its sub-groups, and members of expert panels and expert laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality.
Djeluju neovisno i u skladu s javnim interesom.
They shall undertake to act in the public interest and in an independent manner.
U izjavi iskazuju sve izravne ili neizravne interese koje bi mogli imati u industriji medicinskih proizvoda i ažuriraju tu izjavu u slučaju bilo kakve relevantne promjene.
They shall declare any direct or indirect interests they may have in the medical device industry and update that declaration whenever a relevant change occurs.
Izjava o interesu se javno objavljuje na internetskoj stranici Komisije.
The declaration of interests shall be made publicly available on the Commission website.
Ovaj članak ne primjenjuje se na predstavnike organizacija dionika koji sudjeluju u podskupinama MDCG-a.
This Article shall not apply to the representatives of stakeholder organisations participating in the sub-groups of the MDCG.
Stručnjaci i treće strane koje MDCG poziva za pojedine slučajeve podnose izjavu o svim interesima koje mogu imati u pogledu dotičnog pitanja.
Experts and other third parties invited by the MDCG on a case-by-case basis shall declare any interests they may have in the issue in question.
Članak 108.
Article 108
Registri proizvoda i baze podataka
Device registers and databanks
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 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.
Takvi registri o baze podataka doprinose neovisnoj procjeni dugotrajne sigurnosti i učinkovitosti proizvodâ ili sljedivosti proizvoda za ugradnju, ili svih takvih karakteristika.
Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices, or the traceability of implantable devices, or all of such characteristics.
POGLAVLJE IX.
CHAPTER IX
POVJERLJIVOST, ZAŠTITA PODATAKA, FINANCIRANJE I SANKCIJE
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
Članak 109.
Article 109
Povjerljivost
Confidentiality
Osim ako je drugačije predviđeno u ovoj Uredbi i ne dovodeći u pitanje postojeće nacionalne odredbe i prakse o povjerljivosti u državama članicama, sve stranke koje su uključene u primjenu ove Uredbe poštuju povjerljivost informacija i podataka dobivenih prilikom obavljanja svojih zadaća radi zaštite sljedećeg:
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:
osobnih podataka u skladu s člankom 110.;
personal data, in accordance with Article 110;
komercijalno povjerljivih informacija i poslovnih tajni fizičke ili pravne osobe, uključujući prava intelektualnog vlasništva, osim ako je otkrivanje u javnom interesu;
commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights; unless disclosure is in the public interest;
učinkovite provedbe ove Uredbe, a posebno za potrebe inspekcija, istraga ili revizija.
the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.
Ne dovodeći u pitanje stavak 1., povjerljive informacije koje međusobno razmjenjuju nadležna tijela te nadležna tijela i Komisija ne otkrivaju se bez prethodnog dogovora s izvornim tijelom.
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.
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.
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.
Komisija i države članice mogu razmjenjivati povjerljive informacije s regulatornim tijelima trećih zemalja s kojima su sklopile bilateralne ili multilateralne sporazume o povjerljivosti.
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.
Članak 110.
Article 110
Zaštita podataka
Data protection
Države članice primjenjuju Direktivu 95/46/EZ u pogledu obrade osobnih podataka koja se provodi u državama članicama sukladno ovoj Uredbi.
Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
Uredba (EZ) br.
Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
45/2001 primjenjuje se na obradu osobnih podataka koju provodi Komisija sukladno ovoj Uredbi.
Article 111
Članak 111.
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.
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.
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.
Države članice o tome obavješćuju Komisiju i druge države članice najmanje tri mjeseca prije donošenja strukture i visine pristojbi.
Article 112
Članak 112.
Article 113
Članak 113.
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.
Države članice utvrđuju pravila o sankcijama koje se primjenjuju na kršenje odredaba ove Uredbe i poduzimaju sve potrebne mjere radi osiguranja njihove provedbe.
The Member States shall notify the Commission of those rules and of those measures by 25 February 2020 and shall notify it, without delay, of any subsequent amendment affecting them.
Države članice do 25. veljače 2020. obavješćuju Komisiju o tim pravilima i tim mjerama te je bez odgode obavješćuju o svim naknadnim izmjenama koje na njih utječu.
Article 114
Članak 114.
The Commission shall be assisted by a Committee on Medical Devices.
1.
That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Komisiji pomaže Odbor za medicinske proizvode.
Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Navedeni odbor je odbor u smislu Uredbe (EU) br.
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
182/2011.
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.
Pri upućivanju na ovaj stavak primjenjuje se članak 4.
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.
Uredbe (EU) br.
Article 115
182/2011.
Exercise of the delegation
Pri upućivanju na ovaj stavak primjenjuje se članak 5.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
Uredbe (EU) br.
The power to adopt delegated acts referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) shall be conferred on the Commission for a period of five years from 25 May 2017.
182/2011.
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.
Ako odbor ne da nikakvo mišljenje, Komisija ne donosi nacrt provedbenog akta i primjenjuje se članak 5. stavak 4. treći podstavak Uredbe (EU) br.
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.
182/2011.
The delegation of power referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) may be revoked at any time by the European Parliament or by the Council.
Pri upućivanju na ovaj stavak primjenjuje se članak 8.
A decision to revoke shall put an end to the delegation of the power specified in that decision.
Uredbe (EU) br.
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.
182/2011 u vezi s njezinim člankom 4. ili 5., prema potrebi.
It shall not affect the validity of any delegated acts already in force.
Članak 115.
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.
Izvršavanje delegiranja ovlasti
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Ovlast za donošenje delegiranih akata dodjeljuje se Komisiji podložno uvjetima utvrđenima u ovom članku.
A delegated act adopted pursuant to Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) 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.
Ovlast za donošenje delegiranih akata iz članka 1. stavka 5., članka 3., članka 10. stavka 4., članka 18. stavka 3., članka 19. stavka 4., članka 27. stavka 10., članka 44. stavka 11., članka 52. stavka 5., članka 56. stavka 6., članka 61. stavka 8., članka 70. stavka 8. i članka 106. stavka 15. dodjeljuje se Komisiji na razdoblje od pet godina počevši od 25. svibnja 2017.
That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Komisija izrađuje izvješće o delegiranju ovlasti najkasnije devet mjeseci prije kraja razdoblja od pet godina.
Article 116
Delegiranje ovlasti prešutno se produljuje za razdoblja jednakog trajanja, osim ako se Europski parlament ili Vijeće tom produljenju usprotive najkasnije tri mjeseca prije kraja svakog razdoblja.
Separate delegated acts for different delegated powers
3.
The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation.
Europski parlament ili Vijeće u svakom trenutku mogu opozvati delegiranje ovlasti iz članka 1. stavka 5., članka 3., članka 10. stavka 4., članka 18. stavka 3., članka 19. stavka 4., članka 27. stavka 10., članka 44. stavka 11., članka 52. stavka 5., članka 56. stavka 6., članka 61. stavka 8., članka 70. stavka 8. i članka 106. stavka 15.
Article 117
Odlukom o opozivu prekida se delegiranje ovlasti koje je u njoj navedeno.
Amendment to Directive 2001/83/EC
Opoziv počinje proizvoditi učinke sljedećeg dana od dana objave spomenute odluke u Službenom listu Europske unije ili na kasniji dan naveden u spomenutoj odluci.
In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
On ne utječe na valjanost delegiranih akata koji su već na snazi.
Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council, a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.
Prije donošenja delegiranog akta Komisija se savjetuje sa stručnjacima koje je imenovala svaka država članica u skladu s načelima utvrđenima u Međuinstitucijskom sporazumu o boljoj izradi zakonodavstva od 13. travnja 2016.
If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.
Čim donese delegirani akt Komisija ga istodobno priopćuje Europskom parlamentu i Vijeću.
Article 118
Delegirani akt donesen na temelju članka 1. stavka 5., članka 3., članka 10. stavka 4., članka 18. stavka 3., članka 19. stavka 4., članka 27. stavka 10., članka 44. stavka 11., članka 52. stavka 5., članka 56. stavka 6., članka 61. stavka 8., članka 70. stavka 8. i članka 106. stavka 15. stupa na snagu samo ako Europski parlament ili Vijeće u roku od tri mjeseca od priopćenja tog akta Europskom parlamentu i Vijeću na njega ne podnesu nikakav prigovor ili ako su prije isteka tog roka i Europski parlament i Vijeće obavijestili Komisiju da neće podnijeti prigovore.
Amendment to Regulation (EC) No 178/2002
Taj se rok produljuje za tri mjeseca na inicijativu Europskog parlamenta ili Vijeća.
In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:
Članak 116.
Article 119
Komisija donosi posebni delegirani akt za svaku ovlast koja joj je delegirana u skladu s ovom Uredbom.
Amendment to Regulation (EC) No 1223/2009
Članak 117.
In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
Izmjena Direktive 2001/83/EZ
The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition ‘cosmetic product’.
U Prilogu I. Direktivi 2001/83/EZ točka 12. odjeljka 3.2. zamjenjuje se sljedećom točkom:
Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).’.
Ako je u skladu s člankom 1. stavkom 8. drugim podstavkom ili člankom 1. stavkom 9. drugim podstavkom Uredbe (EU) 2017/745 Europskog parlamenta i Vijeća proizvod reguliran ovom Direktivom, dokumentacija za odobrenje za stavljanje na tržište uključuje, prema potrebi, rezultate ocjenjivanja sukladnosti dijela proizvoda s relevantnim općim zahtjevima sigurnosti i učinkovitosti utvrđenima u Prilogu I. toj Uredbi sadržane u proizvođačevoj EU izjavi o sukladnosti ili relevantnoj potvrdi koju je izdalo prijavljeno tijelo, a koja je omogućila proizvođaču da stavi oznaku CE na medicinski proizvod.
Article 120
Ako dokumentacija ne uključuje rezultate ocjenjivanja sukladnosti iz prvog podstavka i ako je za ocjenjivanje sukladnosti proizvoda, ako se on zasebno upotrebljava, potrebno sudjelovanje prijavljenog tijela u skladu s Uredbom (EU) 2017/745, tijelo zahtijeva od podnositelja zahtjeva da iznese svoje mišljenje o sukladnosti dijela proizvoda s relevantnim općim zahtjevima sigurnosti i učinkovitosti utvrđenima u Prilogu I. toj Uredbi koje izdaje prijavljeno tijelo imenovano u skladu s tom Uredbom za dotičnu vrstu proizvoda.
Transitional provisions
Članak 118.
From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
Izmjene Uredbe (EZ) br.
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC 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 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022.
178/2002
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance.
U članku 2. trećem stavku Uredbe (EZ) br.
They shall however become void at the latest on 27 May 2024.
178/2002 dodaje se sljedeća točka:
By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC 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 either of those Directives, and provided there are no significant changes in the design and intended purpose.
medicinske proizvode u smislu Uredbe (EU) 2017/745 Europskog parlamenta i Vijeća.
However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.
Članak 119.
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 of the applicable requirements relating to the devices it has certified.
Izmjena Uredbe (EZ) br.
Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 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.
1223/2009
By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market prior to 26 May 2020.
U članku 2.
By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified prior 26 May 2020.
Uredbe (EZ) br.
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 2020.
1223/2009 dodaje se sljedeći stavak:
As regards devices subject to the consultation procedure laid down in Article 54, paragraph 5 of this Article shall apply provided that the necessary appointments to the MDCG and expert panels have been made.
Komisija može, na zahtjev države članice ili na vlastitu inicijativu, donijeti potrebne mjere kojima se utvrđuje jesu li određeni proizvod ili skupina proizvoda obuhvaćeni definicijom ‚kozmetičkog proizvoda’.
By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to point (d) of Article 123(3) and ending 18 months later, comply with Article 29(4) and Article 56(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and with, respectively, point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of Directive 93/42/EEC as specified in Decision 2010/227/EU.
Te se mjere donose u skladu s regulatornim postupkom iz članka 32. stavka 2.”
Authorisations granted by the competent authorities of the Member States in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in the authorisation.
Članak 120.
Devices falling within the scope of this Regulation in accordance with points (f) and (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2020 may continue to be placed on the market and put into service in the Member States concerned.
Prijelazne odredbe
Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2020 may continue to be conducted.
Od 26. svibnja 2020. svaka objava obavijesti u vezi s prijavljenim tijelom u skladu s Direktivom 90/385/EEZ i Direktivom 93/42/EEZ prestaje važiti.
As of 26 May 2020, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.
Potvrde koje su izdala prijavljena tijela u skladu s Direktivom 90/385/EEZ i Direktivom 93/42/EEZ prije 25. svibnja 2017. ostaju na snazi do isteka razdoblja navedenog u potvrdi, s iznimkom potvrda izdanih u skladu s Prilogom 4.