natgillin/translations-raw huggingface dataset:
The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment.
a klasu ako se nanose na kožu ili ako se primjenjuju u nosnoj ili usnoj šupljini do ždrijela i postižu svoju namjenu na tim šupljinama i
The notified body shall establish a plan for such unannounced on-site audits but shall not disclose it to the manufacturer.
b klasu u svim drugim slučajevima.
Within the context of such unannounced on-site audits, the notified body shall test an adequate sample of the devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation, with the exception of the devices referred to in the second subparagraph of Article 52(8).
Pravilo 22.
Prior to unannounced on-site audits, the notified body shall specify the relevant sampling criteria and testing procedure.
Aktivni terapijski proizvodi s integriranom ili uključenom dijagnostičkom funkcijom koja znatno utječe na postupanje s pacijentima u vezi s proizvodom kao što su sustavi zatvorene petlje ili automatizirani vanjski defibrilatori razvrstani su u III. klasu.
Instead of, or in addition to, sampling referred to in the second paragraph, the notified body shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation, with the exception of the devices referred to in the second subparagraph of Article 52(8).
PRILOG IX.
Prior to the sampling, the notified body in question shall specify the relevant sampling criteria and testing procedure.
OCJENJIVANJE SUKLADNOSTI NA TEMELJU SUSTAVA UPRAVLJANJA KVALITETOM I OCJENJIVANJA TEHNIČKE DOKUMENTACIJE
The notified body shall provide the manufacturer in question with an on-site audit report which shall include, if applicable, the result of the sample test.
SUSTAV UPRAVLJANJA KVALITETOM
In the case of class IIa and class IIb devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the second paragraph of Section 2.3.
Proizvođač uspostavlja, dokumentira i provodi sustav upravljanja kvalitetom kako je opisano u članku 10. stavku 9. te održava njegovu učinkovitost tijekom životnog ciklusa dotičnih proizvoda.
In the case of class III devices, the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices.
Proizvođač jamči primjenu sustava upravljanja kvalitetom kako je utvrđeno u odjeljku 2., a predmetom je revizije u skladu s odjeljcima 2.3. i 2.4. te nadzora kako je utvrđeno u odjeljku 3.
The notified body shall ensure that the composition of the assessment team is such that there is sufficient experience with the evaluation of the devices, systems and processes concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals.
Ocjenjivanje sustava upravljanja kvalitetom
As a general rule, a lead auditor shall neither lead nor attend audits for more than three consecutive years in respect of the same manufacturer.
Proizvođač prijavljenom tijelu podnosi zahtjev za ocjenjivanje svojeg sustava upravljanja kvalitetom.
If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it.
Zahtjev sadrži:
ASSESSMENT OF THE TECHNICAL DOCUMENTATION
ime proizvođača i adresu njegovog registriranog mjesta poslovanja i svaki dodatni proizvodni pogon obuhvaćen sustavom upravljanja kvalitetom, kao i ime ovlaštenog zastupnika i adresu registriranog mjesta poslovanja ovlaštenog zastupnika ako je on podnio proizvođačev zahtjev,
Assessment of the technical documentation applicable to class III devices and to the class IIb devices referred to in the second subparagraph of Article 52(4)
sve važne informacije o proizvodu ili skupini proizvoda obuhvaćenima sustavom upravljanja kvalitetom,
In addition to the obligations laid down in Section 2, the manufacturer shall lodge with the notified body an application for assessment of the technical documentation relating to the device which it plans to place on the market or put into service and which is covered by the quality management system referred to in Section 2.
pisanu izjavu o tome kako nije podnesen zahtjev nekom drugom prijavljenom tijelu za isti sustav upravljanja kvalitetom povezan s tim proizvodom ili informaciju o svim prethodnim zahtjevima za isti sustav upravljanja kvalitetom povezan s tim proizvodom,
The application shall describe the design, manufacture and performance of the device in question.
nacrt EU izjave o sukladnosti u skladu s člankom 19. i Prilogom IV. za model proizvoda obuhvaćen postupkom ocjenjivanja sukladnosti,
It shall include the technical documentation as referred to in Annexes II and III.
dokumentaciju o proizvođačevu sustavu upravljanja kvalitetom,
The notified body shall examine the application by using staff, employed by it, with proven knowledge and experience regarding the technology concerned and its clinical application.
dokumentiran opis postupaka uspostavljenih za ispunjavanje obveza koje proizlaze iz sustava upravljanja kvalitetom i koje su propisane ovom Uredbom te izjavu kojom dotični proizvođač obećava da će primjenjivati te postupke,
The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of the Regulation.
opis postupaka uspostavljenih kako bi se osiguralo održavanje učinkovitosti i adekvatnosti sustava upravljanja kvalitetom te izjavu kojom proizvođač obećava da će primjenjivati te postupke,
The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests.
dokumentaciju o proizvođačevu sustavu posttržišnog nadzora i, ako je primjenjivo, o planu posttržišnog praćenja učinkovitosti, te postupcima uspostavljenima s ciljem osiguranja usklađenosti s obvezama koje proizlaze iz odredaba o vigilanciji utvrđenih u člancima od 87. do 92.
The notified body shall review the clinical evidence presented by the manufacturer in the clinical evaluation report and the related clinical evaluation that was conducted.
opis postupaka uspostavljenih s ciljem ažuriranja sustava posttržišnog nadzora, uključujući, ako je to primjenjivo, plan posttržišnog praćenja učinkovitosti, i postupaka kojima se osigurava usklađenost s obvezama koje proizlaze iz odredaba o vigilanciji utvrđenih u člancima od 87. do 92., kao i izjavu kojom proizvođač obećava da će primjenjivati te postupke,
The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the device in question or the clinical condition in which it is utilised, for the purposes of that review.
dokumentaciju o planu kliničke procjene i
The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation.
opis postupaka uspostavljenih s ciljem ažuriranja plana kliničke procjene uzimajući u obzir najnovija dostignuća.
The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity.
Provedbom sustava upravljanja kvalitetom osigurava se usklađenost s ovom Uredbom.
For any characteristic of the device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.
Svi elementi, zahtjevi i odredbe koje donosi proizvođač za svoj sustav upravljanja kvalitetom dokumentiraju se sustavno i uredno u obliku priručnika o kvaliteti te pisanih politika i postupaka, kao što su programi, planovi i evidencija o kvaliteti.
The notified body shall verify that the clinical evidence and the clinical evaluation are adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety and performance requirements.
Osim toga, dokumentacija koja se dostavlja za ocjenjivanje sustava upravljanja kvalitetom uključuje odgovarajući opis, posebno sljedećega:
That verification shall include consideration of the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training and the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the PMCF plan proposed, where applicable.
ciljeva proizvođača u pogledu kvalitete;
Based on its assessment of the clinical evidence, the notified body shall consider the clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMCF data.
organizacije poslovanja, a posebno:
The notified body shall clearly document the outcome of its assessment in the clinical evaluation assessment report.
organizacijskih struktura s podjelom odgovornosti osoblja u pogledu ključnih postupaka, odgovornosti rukovodećeg osoblja te njegovih organizacijskih ovlasti,
The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a clinical evaluation assessment report.
metoda praćenja učinkovitosti djelovanja sustava upravljanja kvalitetom, a posebno njegove sposobnosti postizanja željene kvalitete projekta i proizvoda, uključujući kontrolu proizvoda koji nisu sukladni,
If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate.
kada projektiranje, proizvodnju i/ili završnu provjeru i testiranje proizvodâ ili dijelove bilo kojeg od tih postupaka izvodi druga strana, metoda praćenja učinkovitoga djelovanja sustava upravljanja kvalitetom te posebno vrste i opsega nadzora koji se provodi nad tom drugom stranom, i
The certificate shall contain the conclusions of the technical documentation assessment, the conditions of the certificate's validity, the data needed for identification of the approved design, and, where appropriate, a description of the intended purpose of the device.
kada proizvođač nema registrirano mjesto poslovanja u državi članici, nacrt ovlaštenja za imenovanje ovlaštenog zastupnika te pismo namjere ovlaštenog zastupnika da prihvaća ovlaštenje;
Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device.
postupaka i metoda praćenja, provjere, potvrđivanja, i nadzora projektiranja proizvoda te odgovarajuće dokumentacije, kao i podataka te evidencija koji proizlaze iz tih postupaka i metoda.
Where the manufacturer plans to introduce any of the above-mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof.
Ti postupci i metode konkretno obuhvaćaju:
The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 52 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate.
strategiju za usklađenost s propisima, uključujući postupke za utvrđivanje odgovarajućih pravnih zahtjeva, kvalifikaciju, razvrstavanje, postupanje s jednakovrijednošću, izbor postupaka ocjenjivanja sukladnosti i usklađenost s tim postupcima,
In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate.
utvrđivanje primjenjivih općih zahtjeva sigurnosti i učinkovitosti te rješenja za njihovo ispunjenje, uzimajući u obzir primjenjive zajedničke specifikacije i, ako odluči koristiti se njima, usklađene norme ili druga odgovarajuća rješenja,
Specific additional procedures
upravljanje rizicima iz Priloga I. odjeljka 3.,
Assessment procedure for certain class III and class IIb devices
kliničku procjenu u skladu s člankom 61. i Prilogom XIV., uključujući posttržišno kliničko praćenje,
For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product as referred to in Section 6.4. of Annex VIII (Rule 12), the notified body shall, having verified the quality of clinical data supporting the clinical evaluation report of the manufacturer referred to in Article 61(12), prepare a clinical evaluation assessment report which sets out its conclusions concerning the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication or indications and the PMCF plan referred to in Article 10(3) and Part B of Annex XIV.
rješenja za ispunjenje primjenjivih posebnih zahtjeva u vezi s projektiranjem i izradom, uključujući odgovarajuću pretkliničku procjenu, osobito zahtjeve Priloga I. poglavlja II.,
The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer's clinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to the Commission.
rješenja za ispunjenje primjenjivih posebnih zahtjeva u vezi s informacijama koje treba dostaviti uz proizvod, osobito zahtjeva iz Priloga I. poglavlja III.,
The Commission shall immediately transmit those documents to the relevant expert panel referred to in Article 106.
postupke identifikacije proizvoda koji su sastavljeni i ažuriraju se na temelju nacrta, specifikacija ili drugih relevantnih dokumenata u svakoj fazi proizvodnje te
The notified body may be requested to present its conclusions as referred to in point (a) to the expert panel concerned.
upravljanje promjenama u projektiranju ili sustavu upravljanja kvalitetom; i
The expert panel shall decide, under the supervision of the Commission, on the basis of all of the following criteria:
metoda provjere i jamstva kvalitete u proizvodnoj fazi te osobito procesa i postupaka koje treba upotrebljavati, osobito u pogledu sterilizacije, i relevantnih dokumenata; te
the novelty of the device or of the related clinical procedure involved, and the possible major clinical or health impact thereof;
odgovarajućih testiranja i ispitivanja koja treba provesti prije, za vrijeme i nakon proizvodnje, njihove učestalosti te opreme za testiranje kojom se treba koristiti; omogućena je adekvatna sljedivost kalibracije opreme za testiranje.
a significantly adverse change in the benefit-risk profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in the case of failure of the device;
Usto, proizvođač prijavljenom tijelu omogućuje pristup tehničkoj dokumentaciji iz priloga II. i III.
a significantly increased rate of serious incidents reported in accordance with Article 87 in respect of a specific category or group of devices,
Revizija
whether to provide a scientific opinion on the clinical evaluation assessment report of the notified body based on the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the medical indication or indications and the PMCF plan.
Prijavljeno tijelo provodi reviziju sustava upravljanja kvalitetom kako bi utvrdilo ispunjava li on zahtjeve iz odjeljka 2.2.
That scientific opinion shall be provided within a period of 60 days, starting on the day of receipt of the documents from the Commission as referred to in point (a).
Ako proizvođač primjenjuje usklađenu normu ili zajedničku specifikaciju u vezi sa sustavom upravljanja kvalitetom, prijavljeno tijelo ocjenjuje sukladnost s tim normama ili zajedničkim specifikacijama.
The reasons for the decision to provide a scientific opinion on the basis of the criteria in points (i), (ii) and (iii) shall be included in the scientific opinion.
Prijavljeno tijelo pretpostavlja da je sustav upravljanja kvalitetom koji zadovoljava relevantne usklađene norme ili zajedničke specifikacije sukladan sa zahtjevima u okviru tih normi ili zajedničkih specifikacija, osim ako propisno obrazloži zašto to ne čini.
Where the information submitted is not sufficient for the expert panel to reach a conclusion, this shall be stated in the scientific opinion.
U timu revizora prijavljenog tijela nalazi se najmanje jedan član s iskustvom u ocjenjivanju dotične tehnologije u skladu s Prilogom VII. odjeljcima od 4.3. do 4.5.
The expert panel may decide, under the supervision of the Commission, on the basis of the criteria laid down in point (c) not to provide a scientific opinion, in which case it shall inform the notified body as soon as possible and in any event within 21 days of receipt of the documents as referred to in point (a) from the Commission.
U okolnostima u kojima takvo iskustvo nije odmah očito ili primjenjivo prijavljeno tijelo osigurava dokumentirano obrazloženje za sastav tog tima.
The expert panel shall within that time limit provide the notified body and the Commission with the reasons for its decision, whereupon the notified body may proceed with the certification procedure of that device.
Postupak ocjenjivanja obuhvaća jednu reviziju u prostorima proizvođača te, prema potrebi, u prostorima proizvođačevih dobavljača i/ili podizvođača radi provjere proizvodnih i ostalih relevantnih postupaka.
The expert panel shall within 21 days of receipt of the documents from the Commission notify the Commission, through Eudamed whether it intends to provide a scientific opinion, pursuant to point (c), or whether it intends not to provide a scientific opinion, pursuant to point (d).
Osim toga, za proizvode II.a klase i II.b klase, ocjenjivanje sustava upravljanja kvalitetom popraćeno je ocjenjivanjem tehničke dokumentacije za proizvode odabrane na reprezentativnoj osnovi u skladu s odjeljcima od 4.4 do 4.8.
Where no opinion has been delivered within a period of 60 days, the notified body may proceed with the certification procedure of the device in question.
Pri odabiru reprezentativnih uzoraka prijavljeno tijelo uzima u obzir objavljene smjernice koje izrađuje Koordinacijska skupina za medicinske proizvode (MDCG) na temelju članka 105. te posebno novinu tehnologije, sličnosti u projektiranju, tehnologiji, proizvodnji i metodama sterilizacije, namjenu i rezultate svih prethodnih relevantnih ocjenjivanja, npr. u odnosu na fizičke, kemijske, biološke ili kliničke značajke, koja su provedena u skladu s ovom Uredbom.
The notified body shall give due consideration to the views expressed in the scientific opinion of the expert panel.
Dotično prijavljeno tijelo dokumentira obrazloženje odabira uzoraka.
Where the expert panel finds that the level of clinical evidence is not sufficient or otherwise gives rise to serious concerns about the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication(s), and with the PMCF plan, the notified body shall, if necessary, advise the manufacturer to restrict the intended purpose of the device to certain groups of patients or certain medical indications and/or to impose a limit on the duration of validity of the certificate, to undertake specific PMCF studies, to adapt the instructions for use or the summary of safety and performance, or to impose other restrictions in its conformity assessment report, as appropriate.
Ako je sustav upravljanja kvalitetom sukladan s odgovarajućim odredbama ove Uredbe, prijavljeno tijelo izdaje EU potvrdu o sustavu upravljanja kvalitetom.
The notified body shall provide a full justification where it has not followed the advice of the expert panel in its conformity assessment report and the Commission shall without prejudice to Article 109 make both the scientific opinion of the expert panel and the written justification provided by the notified body publicly available via Eudamed.
Prijavljeno tijelo obavješćuje proizvođača o svojoj odluci da izda potvrdu.
The Commission, after consultation with the Member States and relevant scientific experts shall provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020.
Odluka mora sadržavati zaključke revizije i obrazloženo izvješće.
Procedure in the case of devices incorporating a medicinal substance
Dotični proizvođač izvješćuje prijavljeno tijelo koje je odobrilo sustav upravljanja kvalitetom o svakom planu za znatne promjene sustava upravljanja kvalitetom ili obuhvaćenog raspona proizvoda.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.
Prijavljeno tijelo ocjenjuje predložene promjene, utvrđuje potrebu za dodatnim revizijama i provjerava je li sustav upravljanja kvalitetom nakon tih promjena i dalje u skladu sa zahtjevima iz odjeljka 2.2.
Before issuing an EU technical documentation assessment certificate, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the substance into the device.
Ono obavješćuje proizvođača o svojoj odluci koja sadrži zaključke ocjenjivanja i, ako je to primjenjivo, zaključke dodatnih revizija.
Where the device incorporates a human blood or plasma derivative or a substance that, if used separately, may be considered to be a medicinal product falling exclusively within the scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
Odobrenje svih znatnih promjena sustava upravljanja kvalitetom ili obuhvaćenog raspona proizvoda izdaje se kao dodatak EU potvrdi o sustavu upravljanja kvalitetom.
When issuing its opinion, the medicinal products authority consulted shall take into account the manufacturing process and the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body.
Ocjenjivanje nadzora primjenjivo na proizvode II.a klase, II.b klase i III. klase