natgillin/translations-raw huggingface dataset:
to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and performance requirements laid down in this Regulation and Regulation (EU) 2017/746 are adequate to ensure safety and performance of devices, and thereby contribute to identifying whether there is a need to amend Annex I to this Regulation;
Komisija lahko po posvetovanju s Koordinacijsko skupino za medicinske pripomočke svetovalce vključi v osrednji seznam razpoložljivih strokovnjakov, ki sicer niso uradno imenovani v odbor, a so strokovnemu odboru po potrebi na voljo za svetovanje in pomoč pri njegovem delu.
to contribute to the development of device standards, of CS and of scientific guidelines, including product specific guidelines, on clinical investigation of certain devices in particular implantable devices and class III devices;
Ta seznam se objavi na spletnem mestu Komisije.
to assist the competent authorities of the Member States in their coordination activities in particular in the fields of classification and the determination of the regulatory status of devices, clinical investigations, vigilance and market surveillance including the development and maintenance of a framework for a European market surveillance programme with the objective of achieving efficiency and harmonisation of market surveillance in the Union, in accordance with Article 93;
Komisija lahko po posvetovanju s Koordinacijsko skupino za medicinske pripomočke z izvedbenimi akti imenuje strokovne laboratorije na podlagi njihovega strokovnega znanja in izkušenj na področju:
to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue related to the implementation of this Regulation;
fizikalno-kemijskega opisa lastnosti ali
to contribute to harmonised administrative practice with regard to devices in the Member States.
preskušanja biokompatibilnosti ter mikrobiološkega, mehanskega, električnega, elektronskega ali nekliničnega biološko/toksikološkega preskušanja
Article 106
posebnih pripomočkov, kategorij ali skupin pripomočkov.
Provision of scientific, technical and clinical opinions and advice
Komisija imenuje samo tiste strokovne laboratorije, za katere sta država članica ali Skupno raziskovalno središče predložila vlogo za imenovanje.
The Commission shall, by means of implementing acts and in consultation with the MDCG, make provision for expert panels to be designated for the assessment of the clinical evaluation in relevant medical fields as referred to in paragraph 9 of this Article and to provide views in accordance with Article 48(6) of Regulation (EU) 2017/746 on the performance evaluation of certain in vitro diagnostic medical devices and, where necessary, for categories or groups of devices, or for specific hazards relating to categories or groups of devices, observing the principles of highest scientific competence, impartiality, independence and transparency.
Strokovni laboratoriji izpolnjujejo naslednja merila:
The same principles shall apply where the Commission decides to appoint expert laboratories in accordance with paragraph 7 of this Article.
imajo dovolj osebja, ki je ustrezno usposobljeno in ima zadostno znanje in izkušnje na področju pripomočkov, za katere so bili imenovani;
Expert panels and expert laboratories may be designated in areas where the Commission, in consultation with the MDCG, has identified a need for the provision of consistent scientific, technical and/or clinical advice or laboratory expertise in relation to the implementation of this Regulation.
imajo potrebno opremo za izvajanje nalog, ki so jim bile dodeljene;
Expert panels and expert laboratories may be appointed on a standing or temporary basis.
imajo potrebno znanje o mednarodnih standardih in najboljših praksah;
Expert panels shall consist of advisors appointed by the Commission on the basis of up-to-date clinical, scientific or technical expertise in the field and with a geographical distribution that reflects the diversity of scientific and clinical approaches in the Union.
imajo ustrezno upravno ureditev in strukturo;
The Commission shall determine the number of members of each panel in accordance with the requisite needs.
zagotavljajo, da njihovo osebje spoštuje zaupnost informacij in podatkov, pridobljenih pri izvajanju svojih nalog.
The members of expert panels shall perform their tasks with impartiality and objectivity.
Strokovni odbori, imenovani za klinično oceno na ustreznih medicinskih področjih, opravljajo naloge, določene v členu 54(1) in členu 61(2) ter oddelku 5.1 Priloge IX ali oddelku 6 Priloge X, kakor je ustrezno.
They shall neither seek nor take instructions from notified bodies or manufacturers.
Strokovni odbori in strokovni laboratoriji imajo glede na potrebe lahko naslednje naloge:
Each member shall draw up a declaration of interests, which shall be made publicly available.
zagotovitev znanstvene, tehnične in klinične pomoči Komisiji in Koordinacijski skupini za medicinske pripomočke pri izvajanju te uredbe;
The Commission shall establish systems and procedures to actively manage and prevent potential conflicts of interest.
sodelovanje pri razvoju in posodabljanju ustreznih smernic in skupnih specifikacij za
Expert panels shall take into account relevant information provided by stakeholders including patients' organisations and healthcare professionals when preparing their scientific opinions.
klinične raziskave,
The Commission, following consultation with the MDCG, may appoint advisors to expert panels following publication in the Official Journal of the European Union and on the Commission website following a call for expressions of interest.
klinično oceno in klinično spremljanje po dajanju na trg,
Depending on the type of task and the need for specific expertise, advisors may be appointed to the expert panels for a maximum period of three years and their appointment may be renewed.
študije učinkovitosti,
The Commission, following consultation with the MDCG, may include advisors on a central list of available experts who, whilst not being formally appointed to a panel, are available to provide advice and to support the work of the expert panel as needed.
oceno učinkovitosti in spremljanje učinkovitosti po dajanju na trg,
That list shall be published on the Commission website.
fizikalno-kemijski opis lastnosti in
The Commission may, by means of implementing acts and following consultation with the MDCG, designate expert laboratories, on the basis of their expertise in:
preskušanje biokompatibilnosti ter mikrobiološko, mehansko, električno, elektronsko ali neklinično biološko/toksikološko preskušanje
physico-chemical characterisation, or
posebnih pripomočkov oziroma kategorij ali skupin pripomočkov ali za posebne nevarnosti, povezane s kategorijo ali skupino pripomočkov;
microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical biological and toxicological testing
razvoj in pregled smernic za klinično oceno in smernic za oceno učinkovitosti pri izvajanju ugotavljanja skladnosti v skladu z najnovejšimi postopki, kar zadeva klinično oceno in oceno učinkovitosti, fizikalno-kemijski opis lastnosti ter preskušanje biokompatibilnosti in mikrobiološko mehansko, električno, elektronsko ali neklinično toksikološko preskušanje;
of specific devices, categories or groups of devices.
sodelovanje pri razvoju standardov na mednarodni ravni ter zagotovitev, da ti standardi odražajo zadnje stanje tehničnega razvoja;
The Commission shall only designate expert laboratories for which a Member State or the Joint Research Centre has submitted an application for designation.
priprava mnenj po posvetovanjih s proizvajalci v skladu s členom 61(2), priglašenimi organi in državami članicami v skladu z odstavki 11 do 13 tega člena;
Expert laboratories shall satisfy the following criteria:
sodelovanje pri odkrivanju perečih in novih vprašanj v zvezi z varnostjo in učinkovitostjo medicinskih pripomočkov;
have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the devices for which they are designated;
zagotavljanj mnenj v skladu s členom 48(4) Uredbe (EU) 2017/746 o oceni učinkovitosti nekaterih in vitro diagnostičnih medicinskih pripomočkov.
possess the necessary equipment to carry out the tasks assigned to them;
Komisija olajša dostop držav članic in priglašenih organov ter proizvajalcev do svetovanja, ki ga zagotavljajo strokovni odbori in strokovni laboratoriji, med drugim v zvezi z merili za ustrezen nabor podatkov za oceno skladnosti pripomočka, zlasti kar zadeva klinične podatke, potrebne za klinično oceno, fizikalno-kemijski opis lastnosti ter preskušanje biokompatibilnosti in mikrobiološko, mehansko, električno, elektronsko in neklinično toksikološko preskušanje.
have the necessary knowledge of international standards and best practices;
Člani strokovnih odborov si pri sprejemanju znanstvenega mnenja v skladu z odstavkom 9 po najboljših močeh prizadevajo doseči soglasje.
have an appropriate administrative organisation and structure;
Če soglasja ni mogoče doseči, strokovni odbori odločajo z večino svojih članov, v znanstvenem mnenju pa se zabeležijo različna stališča in njihove utemeljitve.
ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks.
Komisija objavi znanstveno mnenje in nasvete, dane v skladu z odstavkoma 9 in 11 tega člena, ter zagotovi upoštevanje vidikov zaupnosti, kakor je določeno v členu 109.
Expert panels appointed for clinical evaluation in relevant medical fields shall fulfil the tasks provided for in Article 54(1) and Article 61(2) and Section 5.1 of Annex IX or Section 6 of Annex X, as applicable.
Smernice za klinično oceno iz točke (c) odstavka 10 se objavijo po posvetovanju s Koordinacijsko skupino za medicinske pripomočke.
Expert panels and expert laboratories may have the following tasks, depending on the requisite needs:
Komisija lahko od proizvajalcev in priglašenih organov zahteva plačilo pristojbin za svetovalne storitve strokovnih odborov in strokovnih laboratorijev.
to provide scientific, technical and clinical assistance to the Commission and the MDCG in relation to the implementation of this Regulation;
O strukturi in višini pristojbin ter o obsegu in strukturi stroškov, ki se lahko povrnejo, odloči Komisija z izvedbenimi akti, pri čemer upošteva cilje ustreznega izvajanja te uredbe, varovanje zdravja in varnosti, podpiranje inovacij in stroškovne učinkovitosti ter potrebo po aktivni udeležbi v strokovnih odborih.
to contribute to the development and maintenance of appropriate guidance and CS for:
Pristojbine, ki se plačajo Komisiji v skladu s postopkom iz odstavka 13 tega člena, se določijo na pregleden način in na podlagi stroškov za opravljene storitve.
clinical investigations,
Pristojbine, ki se plačajo, se zmanjšajo v primeru postopka za posvetovanje o klinični oceni, ki je bil začet v skladu z točko (c) oddelka 5.1 Priloge IX, in vključuje proizvajalca, ki je mikro, malo ali srednje podjetje v smislu Priporočila 2003/361/ES.
clinical evaluation and PMCF,
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115 za spremembo nalog strokovnih odborov in strokovnih laboratorijev iz odstavka 10 tega člena.
performance studies,
Člen 107
performance evaluation and post-market performance follow-up,
Nasprotje interesov
physico-chemical characterisation, and
Člani Koordinacijske skupine za medicinske pripomočke in njenih podskupin ter člani strokovnih odborov in strokovnih laboratorijev ne smejo imeti finančnih ali drugih interesov v industriji medicinskih pripomočkov, ki bi lahko vplivali na njihovo nepristranskost.
microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical toxicological testing
Zavezati se morajo, da bodo delovali v javnem interesu in neodvisno.
for specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices;
Prijaviti morajo kakršne koli neposredne ali posredne interese, ki jih lahko imajo v industriji medicinskih pripomočkov, in te informacije vsakič posodobiti, ko pride do sprememb.
to develop and review clinical evaluation guidance and performance evaluation guidance for performance of conformity assessment in line with the state of the art with regard to clinical evaluation, performance evaluation, physico-chemical characterisation, and microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical toxicological testing;
Izjava o interesih je dostopna javnosti na spletnem mestu Komisije.
to contribute to the development of standards at international level, ensuring that such standards reflect the state of the art;
Ta člen se ne uporablja za predstavnike organizacij deležnikov, ki sodelujejo v podskupinah Koordinacijske skupine za medicinske pripomočke.
to provide opinions in response to consultations by manufacturers in accordance with Article 61(2), notified bodies and Member States in accordance with paragraphs 11 to 13 of this Article.
Strokovnjaki in druge tretje osebe, ki jih za vsak primer posebej povabi Koordinacijska skupina za medicinske pripomočke, prijavijo svoje morebitne interese pri zadevnem vprašanju.
to contribute to identification of concerns and emerging issues on the safety and performance of medical devices;
Člen 108
to provide views in accordance with Article 48(4) of Regulation (EU) 2017/746 on the performance evaluation of certain in vitro diagnostic medical devices.
Registri pripomočkov in podatkovne zbirke
The Commission, shall facilitate the access of Member States and notified bodies and manufacturers to advice provided by expert panels and expert laboratories concerning, inter alia, the criteria for an appropriate data set for assessment of the conformity of a device, in particular with regard to the clinical data required for clinical evaluation, with regard to physico-chemical characterisation, and with regard to microbiological, biocompatibility, mechanical, electrical, electronic and non-clinical toxicological testing.
Komisija in države članice sprejmejo vse ustrezne ukrepe za spodbujanje vzpostavitve registrov in podatkovnih zbirk za posebne vrste pripomočkov, v katerih so določena skupna načela za zbiranje primerljivih informacij.
When adopting its scientific opinion in accordance with paragraph 9, the members of the expert panels shall use their best endeavours to reach consensus.
Takšni registri in podatkovne zbirke prispevajo k neodvisni oceni dolgoročne varnosti in učinkovitosti pripomočkov, sledljivosti pripomočkov za vsaditev ali vseh teh značilnosti.
If consensus cannot be reached, the expert panels shall decide by a majority of their members, and the scientific opinion shall mention the divergent positions and the grounds on which they are based.
POGLAVJE IX
The Commission shall publish the scientific opinion and advice delivered in accordance with paragraphs 9 and 11 of this Article, ensuring consideration of aspects of confidentiality as set out in Article 109.
ZAUPNOST, VARSTVO PODATKOV, FINANCIRANJE IN KAZNI
The clinical evaluation guidance referred to in point (c) of paragraph 10 shall be published following consultation with the MDCG.
Člen 109
The Commission may require manufacturers and notified bodies to pay fees for the advice provided by expert panels and expert laboratories.
Zaupnost
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.
Razen če v tej uredbi ni drugače določeno in brez poseganja v obstoječe nacionalne določbe in prakse držav članic o zaupnosti, vse strani, vključene v uporabo te uredbe, spoštujejo zaupnost informacij in podatkov, pridobljenih pri izvajanju svojih nalog, da se zaščitijo:
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.
osebni podatki v skladu s členom 110;
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.
zaupne poslovne informacije in poslovne skrivnosti fizičnih ali pravnih oseb, vključno s pravicami intelektualne lastnine; razen če je razkritje v javnem interesu;
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.
učinkovito izvajanje te uredbe, zlasti za namene inšpekcijskih pregledov, raziskav ali presoj.
Article 107
Brez poseganja v odstavek 1 se informacije, ki jih zaupno izmenjajo pristojni organi ter pristojni organi in Komisija, ne razkrijejo brez predhodnega dogovora z organom, ki jih je sporočil.
Conflict of interests
Odstavka 1 in 2 ne vplivata niti na pravice in obveznosti Komisije, držav članic in priglašenih organov v zvezi z izmenjavo informacij in razširjenjem opozoril niti na obveznost zadevnih oseb, da zagotovijo podatke v skladu s kazenskim pravom.
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.
Komisija in države članice lahko izmenjajo zaupne informacije z regulativnimi organi tretjih držav, s katerimi so sklenile dvostranske ali večstranske dogovore o zaupnosti.
They shall undertake to act in the public interest and in an independent manner.
Člen 110
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.
Varstvo podatkov
The declaration of interests shall be made publicly available on the Commission website.
Države članice pri obdelavi osebnih podatkov v državah članicah v skladu s to uredbo uporabljajo Direktivo 95/46/ES.
This Article shall not apply to the representatives of stakeholder organisations participating in the sub-groups of the MDCG.
Komisija pri obdelavi osebnih podatkov v skladu s to uredbo uporablja Uredbo (ES) št. 45/2001.
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.
Člen 111
Article 108
Zaračunavanje pristojbin
Device registers and databanks
Ta uredba ne posega v možnost držav članic, da zaračunavajo pristojbine za dejavnosti, določene v tej uredbi, če se višina pristojbin določi na pregleden način in na podlagi načel povračila stroškov.
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.
Države članice o tem obvestijo Komisijo in druge države članice najmanj tri mesece pred predvidenim sprejetjem strukture in višine pristojbin.
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.
Struktura in višina pristojbin sta na zahtevo javno dostopni.
CHAPTER IX
Člen 112
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
Financiranje dejavnosti v zvezi z imenovanjem in spremljanjem priglašenih organov
Article 109
Stroške, povezane s skupnimi dejavnostmi ocenjevanja, krije Komisija.
Confidentiality
Komisija z izvedbenimi akti določi obseg in strukturo stroškov, ki se lahko povrnejo, ter druga potrebna izvedbena pravila.
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:
Člen 113
personal data, in accordance with Article 110;
Kazni
commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights; unless disclosure is in the public interest;
Države članice določijo pravila o kaznih, ki se uporabljajo za kršitve te uredbe, in sprejmejo vse potrebne ukrepe za zagotovitev, da se te kazni izvajajo.
the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.
Te kazni morajo biti učinkovite, sorazmerne in odvračilne.
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.
Države članice o teh pravilih uradno obvestijo Komisijo do 25. februarja 2020 in jo brez odlašanja uradno obvestijo o vsakršni naknadni spremembi, ki nanje vpliva.
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.
POGLAVJE X
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.
KONČNE DOLOČBE
Article 110
Člen 114
Data protection
Postopek v odboru
Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
Komisiji pomaga Odbor za medicinske pripomočke.
Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
Navedeni odbor je odbor v smislu Uredbe (EU) št. 182/2011.
Article 111
Pri sklicevanju na ta odstavek se uporablja člen 4 Uredbe (EU) št. 182/2011.
Levying of fees
Pri sklicevanju na ta odstavek se uporablja člen 5 Uredbe (EU) št. 182/2011.
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.
Kadar odbor ne poda mnenja, Komisija osnutka izvedbenega akta ne sprejme in se uporabi tretji pododstavek člena 5(4) Uredbe (EU) št. 182/2011.
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.
Pri sklicevanju na ta odstavek se uporablja člen 8 Uredbe (EU) št. 182/2011 v povezavi s členom 4 ali 5 navedene uredbe, kakor je primerno.
The structure and level of fees shall be made publicly available on request.
Člen 115
Article 112
Izvajanje prenosa pooblastila
Funding of activities related to designation and monitoring of notified bodies
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.
The costs associated with joint assessment activities shall be covered by the Commission.
Prenos pooblastila se samodejno podaljšuje za enako dolga obdobja, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece pred koncem vsakega obdobja.
The Commission shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other necessary implementing rules.
Prenos pooblastila iz členov 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) in 106(15) lahko kadar koli prekliče Evropski parlament ali Svet.
Article 113
S sklepom o preklicu preneha veljati prenos pooblastila iz navedenega sklepa.
Penalties
Sklep začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu.