natgillin/translations-raw huggingface dataset:
The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer.
Odgovornost pooblaščenega predstavnika, določena v tej uredbi, ne posega v določbe Direktive 85/374/EGS in skladno s tem bi pooblaščeni predstavnik moral biti solidarno odgovoren z uvoznikom in proizvajalcem.
The tasks of an authorised representative should be defined in a written mandate.
Naloge pooblaščenega predstavnika bi bilo treba opredeliti v pisnem pooblastilu.
Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance.
Ob upoštevanju vloge pooblaščenih predstavnikov bi bilo treba jasno opredeliti minimalne zahteve, ki bi jih morali izpolnjevati, vključno z zahtevo, da imajo na voljo osebo, ki izpolnjuje minimalne pogoje glede usposobljenosti, ki bi morali biti podobni tistim, veljavnim za osebo, ki je pri proizvajalcu odgovorna za skladnost z zakonodajo.
To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify when a distributor, importer or other person is to be considered the manufacturer of a device.
Za zagotovitev pravne varnosti v zvezi z obveznostmi gospodarskih subjektov je treba pojasniti, kdaj se distributer, uvoznik ali druga oseba šteje za proizvajalca pripomočka.
Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety and from the need for protection of intellectual property rights provided for under Article 36 TFEU.
Vzporedna trgovina z izdelki, ki so že bili dani na trg, je na podlagi člena 34 PDEU zakonita oblika trgovine na notranjem trgu, za katero veljajo omejitve zaradi potrebe po varovanju zdravja in varnosti ter potrebe po varstvu pravic intelektualne lastnine, določenih v členu 36 PDEU.
Application of the principle of parallel trade is, however, subject to different interpretations in the Member States.
Vendar se uporaba načela vzporedne trgovine v državah članicah različno razlaga.
The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the Court of Justice [20] in other relevant sectors and existing good practice in the field of medical devices.
Ob upoštevanju sodne prakse Sodišča [20] v drugih relevantnih sektorjih in obstoječe dobre prakse na področju medicinskih pripomočkov bi bilo zato treba v tej uredbi opredeliti pogoje, zlasti zahteve za ponovno označevanje in prepakiranje.
The reprocessing and further use of single-use devices should only take place where permitted by national law and while complying with the requirements laid down in this Regulation.
Ponovna obdelava in nadaljnja uporaba pripomočkov za enkratno uporabo bi morala biti mogoča le, če to dovoljuje nacionalno pravo in če so izpolnjene zahteve iz te uredbe.
The reprocessor of a single-use device should be considered to be the manufacturer of the reprocessed device and should assume the obligations incumbent on manufacturers under this Regulation.
Obdelovalec pripomočka za enkratno uporabo bi se moral šteti za proizvajalca ponovno obdelanega pripomočka in bi moral prevzeti obveznosti, naložene proizvajalcem na podlagi te uredbe.
Nevertheless, Member States should have the possibility of deciding that the obligations relating to reprocessing and re-use of single-use devices within a health institution or by an external reprocessor acting on its behalf may differ from the obligations on a manufacturer described in this Regulation.
Kljub temu bi morale imeti države članice možnost odločanja, da se obveznosti glede ponovne obdelave in ponovne uporabe pripomočkov za enkratno uporabo v zdravstveni ustanovi ali s strani zunanjega obdelovalca, ki deluje v imenu zdravstvene ustanove, lahko razlikujejo od obveznosti proizvajalca iz te uredbe.
In principle, such divergence should only be permitted where reprocessing and reuse of single-use devices within a health institution or by an external reprocessor are compliant with CS that have been adopted, or, in the absence of such CS, with relevant harmonised standards and national provisions.
Načeloma bi morala taka odstopanja biti dovoljena samo, če sta ponovna obdelava in ponovna uporaba pripomočkov za enkratno uporabo v zdravstveni ustanovi ali s strani zunanjega obdelovalca v skladu s sprejetimi skupnimi specifikacijami ali, če teh specifikacij ni, z ustreznimi harmoniziranimi standardi in nacionalnimi določbami.
The reprocessing of such devices should ensure an equivalent level of safety and performance to that of the corresponding initial single-use device.
S ponovno obdelavo takih pripomočkov bi bilo treba zagotoviti enakovredno raven varnosti in učinkovitosti, kot je bila zagotovljena pri ustreznem prvotnem pripomočku za enkratno uporabo.
Patients who are implanted with a device should be given clear and easily accessible essential information allowing the implanted device to be identified and other relevant information about the device, including any necessary health risk warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.
Pacientom, ki imajo vsajen pripomoček, bi bilo treba zagotoviti jasne in lahko dostopne bistvene informacije, ki omogočajo prepoznavanje vsajenega pripomočka, in druge relevantne informacije o pripomočku, vključno z vsemi potrebnimi opozorili o zdravstvenem tveganju ali previdnostnimi ukrepi glede zdravstvenega tveganja, ki jih je treba sprejeti, na primer navedbe, ali je pripomoček združljiv z nekaterimi diagnostičnimi pripomočki ali skenerji, ki se uporabljajo za varnostne kontrole.
Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose.
Pripomočki bi praviloma morali biti opremljeni z oznako CE, ki dokazuje njihovo skladnost s to uredbo in jim omogoča prosti pretok po Uniji in dajanje v uporabo v skladu s predvidenim namenom.
Member States should not create obstacles to the placing on the market or putting into service of devices that comply with the requirements laid down in this Regulation.
Države članice ne bi smele ovirati dajanja na trg ali v uporabo pripomočkov, ki izpolnjujejo zahteve iz te uredbe.
However, Member States should be allowed to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.
Vendar bi morale države članice imeti možnost, da se odločijo za omejitev uporabe določene vrste pripomočkov v zvezi z vidiki, ki niso zajeti v tej uredbi.
The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities.
Sledljivost pripomočkov s sistemom edinstvene identifikacije pripomočka (v nadaljnjem besedilu: sistem UDI – Unique Device Identification system), temelječim na mednarodnih smernicah, bi zaradi boljšega poročanja o zapletih, ciljnih varnostnih korektivnih ukrepov in boljšega nadzora s strani pristojnih organov morala bistveno povečati učinkovitost dejavnosti v zvezi z varnostjo pripomočkov po dajanju na trg.
It should also help to reduce medical errors and to fight against falsified devices.
Prispevati bi morala tudi k zmanjšanju zdravstvenih napak ter boju proti ponarejenim pripomočkom.
Use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those settings.
Uporaba sistema UDI bi morala izboljšati tudi nakupno politiko in politiko odstranjevanja odpadkov ter upravljanje zalog v zdravstvenih ustanovah in pri drugih gospodarskih subjektih ter biti po možnosti skladna z drugimi sistemi preverjanja, ki so že vzpostavljeni v teh okoljih.
The UDI system should apply to all devices placed on the market except custom-made devices, and be based on internationally recognised principles including definitions that are compatible with those used by major trade partners.
Sistem UDI bi se moral uporabljati za vse pripomočke, dane na trg, razen za pripomočke, izdelane za posameznega uporabnika, in bi moral temeljiti na mednarodno priznanih načelih, med drugim tudi na opredelitvah, združljivih s tistimi, ki jih uporabljajo pomembni trgovski partnerji.
In order for the UDI system to become functional in time for the application of this Regulation, detailed rules should be laid down in this Regulation.
Da bo sistem UDI vzpostavljen pravočasno glede na začetek uporabe te uredbe, bi bilo treba v njej določiti podrobna pravila.
Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Preglednost in ustrezen dostop do informacij, ustrezno predstavljenih za predvidenega uporabnika, sta ključna v javnem interesu, da se tako zavaruje javno zdravje, pacientom in zdravstvenim delavcem omogoči večja vloga in sprejemanje ozaveščenih odločitev ter da se zagotovi trdna podlaga za sprejemanje regulativnih odločitev in okrepi zaupanje v regulativni sistem.
One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance.
Eden od ključnih vidikov pri uresničevanju ciljev te uredbe je vzpostavitev evropske podatkovne zbirke za medicinske pripomočke (v nadaljnjem besedilu: Eudamed), ki bi morala združevati različne elektronske sisteme za zbiranje in obdelavo informacij o pripomočkih na trgu, zadevnih gospodarskih subjektih, nekaterih vidikih ugotavljanja skladnosti, priglašenih organih, certifikatih, kliničnih raziskavah, vigilanci in nadzoru trga.
The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission.
S podatkovno zbirko naj bi se povečala splošna preglednost, tudi z boljšim dostopom javnosti in zdravstvenih delavcev do informacij, preprečilo podvajanje zahtev za poročanje, izboljšalo usklajevanje med državami članicami, pretok informacij med gospodarskimi subjekti, priglašenimi organi ali sponzorji in državami članicami, med državami članicami samimi ter med njimi in Komisijo pa racionaliziral in olajšal.
Within the internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices set up by Commission Decision 2010/227/EU [21].
Ker se na notranjem trgu to lahko učinkovito zagotovi samo na ravni Unije, bi morala Komisija še naprej razvijati in upravljati evropsko banko podatkov za medicinske pripomočke, ki je bila ustanovljena s Sklepom Komisije 2010/227/EU [21].
To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature.
Da bi olajšali delovanje Eudameda, bi morala biti mednarodno potrjena nomenklatura o medicinskih pripomočkih brezplačno na voljo proizvajalcem ter drugim fizičnim in pravnim osebam, ki morajo v skladu s to uredbo uporabljati navedeno nomenklaturo.
Furthermore, that nomenclature should be available, where reasonably practicable, free of charge also to other stakeholders.
Ta nomenklatura bi morala biti brezplačno na voljo tudi drugim deležnikom, kjer je to upravičeno in izvedljivo.
Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market.
Informacije o pripomočkih na trgu, zadevnih gospodarskih subjektih in certifikatih, zbrane v elektronskih sistemih Eudameda, bi morale javnosti omogočati ustrezno obveščenost o pripomočkih na trgu Unije.
The electronic system on clinical investigations should serve as a tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and to report serious adverse events, device deficiencies and related updates.
Elektronski sistem o kliničnih raziskavah bi moral služiti kot orodje za sodelovanje med državami članicami, sponzorjem pa omogočati, da prostovoljno vložijo enotno vlogo za več držav članic in poročajo o resnih neželenih dogodkih, pomanjkljivostih pripomočka in s tem povezanih posodobitvah.
The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of the evaluation of such incidents and events by competent authorities.
Elektronski sistem o vigilanci bi proizvajalcem moral omogočati poročanje o resnih zapletih in drugih dogodkih, o katerih je treba poročati, pristojnim organom pa bi moral biti v pomoč pri usklajevanju ocenjevanja teh zapletov in dogodkov.
The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities.
Elektronski sistem za nadzor trga bi moral služiti kot orodje za izmenjavo informacij med pristojnimi organi.
In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the European Parliament and of the Council [22] applies to the processing of personal data carried out in the Member States, under the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States.
Za obdelavo osebnih podatkov, zbranih in obdelanih v elektronskih sistemih Eudameda, ki jo v državah članicah pod nadzorom pristojnih organov držav članic izvajajo zlasti javni neodvisni organi, ki jih imenujejo države članice, se uporablja Direktiva 95/46/ES Evropskega parlamenta in Sveta [22].
Regulation (EC) No 45/2001 of the European Parliament and of the Council [23] applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor.
Za obdelavo osebnih podatkov, ki jo v okviru te uredbe in pod nadzorom Evropskega nadzornika za varstvo podatkov izvaja Komisija, se uporablja Uredba (ES) št. 45/2001 Evropskega parlamenta in Sveta [23].
In accordance with Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems.
V skladu z Uredbo (ES) št. 45/2001 bi bilo treba Komisijo imenovati za upravljavca Eudameda in njegovih elektronskih sistemov.
For implantable devices and for class III devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.
Za pripomočke za vsaditev in za pripomočke razreda III bi morali proizvajalci v javno dostopnem dokumentu povzeti glavne vidike glede varnosti in učinkovitosti pripomočka ter rezultate klinične ocene.
The summary of safety and clinical performance for a device should include in particular the place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when compared to the diagnostic or therapeutic alternatives and the specific conditions under which that device and its alternatives can be considered.
Povzetek o varnosti in klinični učinkovitosti za pripomoček bi moral vsebovati zlasti umestitev pripomočka glede na diagnostične ali terapevtske možnosti, ob upoštevanju klinične ocene tega pripomočka v primerjavi z diagnostičnimi ali terapevtskimi alternativami ter posebnih pogojev, pod katerimi bi lahko uporabili ta pripomoček in njegove alternative.
The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens' confidence in the system.
Ustrezno delovanje priglašenih organov je ključno za zagotavljanje visoke ravni varovanja zdravja in varnosti ter za krepitev zaupanja državljanov v sistem.
Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.
Imenovanje in spremljanje priglašenih organov, ki ju v skladu s podrobnimi in strogimi merili opravljajo države članice, bi zato bilo treba nadzirati na ravni Unije.
Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on clinical evaluation, should be critically evaluated by the authority responsible for notified bodies.
Ocene tehnične dokumentacije proizvajalcev, zlasti dokumentacije o klinični oceni, ki jih opravijo priglašeni organi, bi moral kritično ovrednotiti organ, pristojen za priglašene organe.
That evaluation should be part of the risk-based approach to the oversight and monitoring activities of notified bodies and should be based on sampling of the relevant documentation.
Ta ocena bi morala biti del pristopa, ki temelji na tveganju, za nadzor in spremljanje dejavnosti priglašenega organa in bi morala temeljiti na vzorčenju ustrezne dokumentacije.
The position of notified bodies vis-à-vis manufacturers should be strengthened, including with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification.
Vlogo priglašenih organov do proizvajalcev bi bilo treba okrepiti, tudi njihovo pravico in obveznost, da izvajajo nenapovedane presoje na kraju samem in fizikalne ali laboratorijske teste na pripomočkih, da se zagotovi izpolnjevanje vseh zahtev s strani proizvajalcev tudi po prejemu izvirnega certifikata.
To increase transparency with regard to the oversight of notified bodies by national authorities, the authorities responsible for notified bodies should publish information on the national measures governing the assessment, designation and monitoring of notified bodies.
Da bi povečali preglednost nadzora nacionalnih organov nad priglašenimi organi, bi morali organi, pristojni za priglašene organe, objaviti informacije o nacionalnih predpisih, ki urejajo ocenjevanje, imenovanje in spremljanje priglašenih organov.
In accordance with good administrative practice, this information should be kept up to date by those authorities in particular to reflect relevant, significant or substantive changes to the procedures in question.
V skladu z dobro upravno prakso bi morali ti organi te informacije redno posodabljati, zlasti v primeru relevantnih, pomembnih ali vsebinskih sprememb zadevnih postopkov.
The Member State in which a notified body is established should be responsible for enforcing the requirements of this Regulation with regard to that notified body.
Država članica, v kateri je sedež priglašenega organa, bi morala biti odgovorna za uveljavljanje zahtev iz te uredbe, ki se nanašajo na ta priglašeni organ.
In view, in particular, of the responsibility of Member States for the organisation and delivery of health services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for the conformity assessment of devices and established on their territory as far as issues that are not regulated in this Regulation are concerned.
Predvsem zato, ker so države članice odgovorne za organizacijo in zagotavljanje zdravstvenih storitev in zdravstvene oskrbe, bi morale imeti možnost, da za vprašanja, ki niso urejena v tej uredbi, določijo dodatne zahteve za priglašene organe s sedežem na njihovem ozemlju, ki so pristojni za ugotavljanje skladnosti pripomočkov.
Any such additional requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal treatment of notified bodies.
Dodatne zahteve, ki bi jih tako določile, ne bi smele vplivati na bolj specifično horizontalno zakonodajo Unije o priglašenih organih in enakopravno obravnavo priglašenih organov.
For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert panels to scrutinise their clinical evaluation assessment report.
Kar zadeva pripomočke za vsaditev razreda III in aktivne pripomočke razreda IIb, namenjene dajanju in/ali odstranjevanju zdravila, bi morali priglašeni organi, razen v določenih primerih, strokovne odbore obvezno zaprositi za pregled njihovega poročila o vrednotenju klinične ocene.
Competent authorities should be informed about devices that have been granted a certificate following a conformity assessment procedure involving an expert panel.
Pristojni organi bi morali biti obveščeni o pripomočkih, za katere je bil izdan certifikat po zaključenem postopku ugotavljanja skladnosti, v katerega je vključen strokovni odbor.
The consultation of expert panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and developing CS on categories of devices that have undergone that consultation process.
Posvetovanju s strokovnimi odbori o klinični oceni bi morala slediti harmonizirana ocena medicinskih pripomočkov z visoko stopnjo tveganja z izmenjavo strokovnega znanja o kliničnih vidikih in oblikovanjem skupnih specifikacij za kategorije pripomočkov, za katere je bil uporabljen ta postopek posvetovanja.
For class III devices and for certain class IIb devices, a manufacturer should be able to consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or investigation, on its clinical development strategy and on proposals for clinical investigations.
Kar zadeva pripomočke razreda III in določene pripomočke razreda IIb, bi proizvajalec moral imeti možnost, da se pred svojo klinično oceno in/ali raziskavo prostovoljno posvetuje s strokovnim odborom o svoji strategiji kliničnega razvoja in predlogih za klinične raziskave.
It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the division of devices into four product classes in line with international practice.
Zlasti za namene postopkov ugotavljanja skladnosti je treba ohraniti razvrstitev pripomočkov v štiri razrede izdelkov v skladu z mednarodno prakso.