natgillin/translations-raw huggingface dataset:
In that context, it is appropriate to provide that certain rules of this Regulation, as regards devices manufactured and used only within health institutions, including hospitals as well as institutions, such as laboratories and public health institutes that support the health care system and/or address patient needs, but which do not treat or care for patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner.
V tem okviru je ustrezno določiti, da se nekatera pravila te uredbe ne uporabljajo v zvezi z pripomočki, ki se proizvajajo in uporabljajo le v zdravstvenih ustanovah, med katere spadajo bolnišnice in ustanove, kot so laboratoriji in javne zdravstvene ustanove, ki podpirajo zdravstveni sistem in/ali se odzivajo na potrebe pacientov, vendar ne zdravijo ali oskrbujejo pacientov neposredno, saj bodo cilji te uredbe kljub temu še vedno sorazmerno doseženi.
It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres.
Poudariti je treba, da pojem „zdravstvena ustanova“ v tej uredbi ne zajema subjektov, ki v prvi vrsti uresničujejo interese, povezane z zdravjem in zdravim načinom življenja, kot so telovadnice, zdravilišča, centri dobrega počutja in fitnes centri.
In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC [10].
Ker lahko fizične ali pravne osebe v skladu z veljavnim pravom Unije in nacionalnim pravom zahtevajo nadomestilo za škodo, ki jo je povzročil pripomoček z napako, je primerno, da se od proizvajalcev zahteva sprejetje ukrepov za zagotovitev zadostnih finančnih sredstev za kritje njihove morebitne odgovornosti v skladu z Direktivo Sveta 85/374/EGS [10].
In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device.
V tem smislu je tudi primerno, da se določijo pravila, ki pristojnemu organu nalagajo, da mora olajšati zagotavljanje informacij osebam, ki jih je poškodoval pripomoček z napako.
In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting incidents and field safety corrective actions.
Proizvajalci bi tudi morali vzpostaviti sistem za obvladovanje tveganja ter sistem za poročanje o zapletih in varnostnih korektivnih ukrepih, da bi tako čim bolj zmanjšali tveganja ali preprečili zaplete v zvezi s pripomočki.
The risk management system should be carefully aligned with and reflected in the performance evaluation process for the device, including the clinical risks to be addressed as part of performance studies, performance evaluation and post-market performance follow-up.
Sistem obvladovanja tveganja bi moral biti skrbno usklajen z ocenjevanjem učinkovitosti pripomočka in v njej upoštevan, zajemati pa bi moral tudi klinična tveganja, ki se preučijo v okviru študij učinkovitosti, ocene učinkovitosti in spremljanja učinkovitosti po dajanju na trg.
The risk management and performance evaluation processes should be inter-dependent and should be regularly updated.
Obvladovanje tveganja in ocena učinkovitosti bi morala biti medsebojno odvisna in bi ju bilo treba redno posodabljati.
It should be ensured that supervision and control of the manufacture of devices, as well as post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
Zagotoviti bi bilo treba, da nadzor in kontrolo proizvodnje pripomočkov ter dejavnost njihovega nadzora po dajanju na trg in dejavnosti vigilance v organizaciji proizvajalca izvaja oseba, ki je pristojna za skladnost z zakonodajo in izpolnjuje minimalne pogoje glede usposobljenosti.
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 [11] in other relevant sectors and existing good practice in the field of in vitro diagnostic medical devices.
Ob upoštevanju sodne prakse Sodišča [11] v drugih relevantnih sektorjih in obstoječe dobre prakse na področju in vitro diagnostičnih medicinskih pripomočkov bi bilo zato treba v tej uredbi opredeliti pogoje, zlasti zahteve za ponovno označevanje in prepakiranje.
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 UDI system should apply to all devices placed on the market except devices for performance studies, 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 za študije učinkovitosti, 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 and in Regulation (EU) 2017/745 of the European Parliament and of the Council [12].
Da bo sistem UDI vzpostavljen pravočasno glede na začetek uporabe te uredbe, bi bilo treba v njej in Uredbi (EU) 2017/745 Evropskega parlamenta in Sveta [12] 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, primerno 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, performance studies, 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, študijah učinkovitosti, 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 [13].
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 [13].
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 obveščenost o pripomočkih na trgu Unije.
The electronic system on performance studies 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 študijah učinkovitosti 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 regarding market surveillance should be a tool for the exchange of information between competent authorities.
Elektronski sistem za nadzor trga bi moral služiti kot sredstvo 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 [14] 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 [14].
Regulation (EC) No 45/2001 of the European Parliament and of the Council [15] 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 [15].
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 class C and D devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the performance evaluation in a document that should be publicly available.
Za pripomočke razreda C in D bi morali proizvajalci v javno dostopnem dokumentu povzeti glavne vidike glede varnosti in učinkovitosti pripomočka ter rezultate ocene učinkovitosti.
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 performance evaluation, should be critically evaluated by the authority responsible for notified bodies.
Ocene tehnične dokumentacije proizvajalcev, zlasti dokumentacije o oceni učinkovitosti, ki jih opravijo priglašeni organi, bi moral kritično ovrednotiti organ, pristojen za priglašene organe.
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 oceno, imenovanje in spremljanje priglašenih organov.
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.
For class D devices, competent authorities should be informed about certificates granted by notified bodies and be given the right to scrutinise the assessment conducted by notified bodies.
Pristojne organe bi bilo treba obvestiti o certifikatih za pripomočke razreda D, ki jih odobrijo priglašeni organi, in jim podeliti pristojnost za pregled ocene priglašenih organov.
For class D devices for which no CS exist it is appropriate to provide that where it is the first certification for that specific type of device and there is no similar device on the market having the same intended purpose and based on similar technology, notified bodies should, in addition to the laboratory testing of the performance claimed by the manufacturer and the compliance of the device by the EU reference laboratories, be obliged to request expert panels to scrutinise their performance evaluation assessment reports.
Za pripomočke razreda D, za katere ni skupnih specifikacij, je ustrezno določiti, da bi morali priglašeni organi v primeru, ko gre za prvo certificiranje te specifične vrste pripomočka, za katerega na trgu ni nobenega podobnega pripomočka z enakim predvidenim namenom, ki bi temeljil na podobni tehnologiji, poleg laboratorijskih preskusov učinkovitosti, kot jo navaja proizvajalec, in skladnosti pripomočka, opravljenih v referenčnih laboratorijih Evropske unije, strokovne odbore obvezno zaprositi za pregled njihovih poročil o vrednotenju ocene učinkovitosti.
The consultation of expert panels in relation to the performance evaluation should lead to a harmonised evaluation of high-risk in vitro diagnostic medical devices by sharing expertise on performance aspects and developing CS on categories of devices that have undergone that consultation process.
Posvetovanju s strokovnimi odbori o oceni učinkovitosti bi morala slediti harmonizirana ocena in vitro diagnostičnih medicinskih pripomočkov z visoko stopnjo tveganja z izmenjavo strokovnega znanja o vidikih glede učinkovitosti in oblikovanjem skupnih specifikacij za kategorije pripomočkov, za katere je bil uporabljen ta postopek posvetovanja.
To enhance patient safety and to take due account of technological progress, the current classification system for devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the corresponding conformity assessment procedures should be accordingly adapted.
Za večjo varnost pacientov in upoštevanje tehnološkega napredka bi bilo treba v skladu z mednarodno prakso temeljito spremeniti sedanji sistem razvrščanja pripomočkov iz Direktive 98/79/ES in ustrezno prilagoditi ustrezne postopke ugotavljanja skladnosti.
It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in four risk classes and to establish a set of robust risk-based classification rules, in line with international practice.
Zlasti za namene postopkov ugotavljanja skladnosti je treba pripomočke razvrstiti v štiri razrede tveganja in v skladu z mednarodno prakso oblikovati trden niz pravil za razvrščanje na podlagi tveganja.
The conformity assessment procedure for class A devices should be carried out, as a general rule, under the sole responsibility of manufacturers, since such devices pose a low risk to patients.
Zaradi nizke stopnje tveganja pripomočkov razreda A za paciente, bi moral biti postopek ugotavljanja skladnosti teh pripomočkov praviloma v izključni pristojnosti proizvajalcev.
For class B, class C and class D devices, an appropriate level of involvement of a notified body should be compulsory.
Za pripomočke razredov B, C in D bi morala biti obvezna ustrezna raven vključenosti priglašenega organa.
It is necessary to clarify the requirements regarding batch release verification for the highest risk devices.
Razjasniti je treba zahteve glede preverjanja pri sprostitvi serij pripomočkov z najvišjo stopnjo tveganja.
EU reference laboratories should be enabled to verify by laboratory testing the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
Referenčnim laboratorijem EU bi bilo treba omogočiti, da z laboratorijskim preskušanjem preverijo učinkovitost, kot jo navaja proizvajalec, in skladnost pripomočkov z najvišjo stopnjo tveganja z veljavnimi skupnimi specifikacijami, kadar so takšne skupne specifikacije na voljo, ali na drugačen način, ki ga izbere proizvajalec za zagotavljanje vsaj enakovredne ravni varnosti in učinkovitosti.
To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical evidence.
Za zagotovitev visoke stopnje varnosti in učinkovitosti bi moralo dokazovanje skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti, določenimi v tej uredbi, temeljiti na kliničnih dokazih.
It is necessary to clarify the requirements for the demonstration of the clinical evidence, that is based on data on scientific validity, and the analytical performance and clinical performance of the device.
Pojasniti je treba zahteve glede dokazovanja teh kliničnih dokazov, ki temeljijo na podatkih o znanstveni veljavnosti ter analitski in klinični učinkovitosti pripomočka.
To allow for a structured and transparent process, generating reliable and robust data, sourcing and assessment of available scientific information and data generated in performance studies should be based on a performance evaluation plan.
Da bi omogočili strukturiran in pregleden postopek, s katerim bi pridobili zanesljive in ponovljive podatke, bi morala pridobivanje in ocena razpoložljivih znanstvenih informacij in podatkov, pridobljenih s študijo učinkovitosti, temeljiti na načrtu ocene učinkovitosti.
As a general rule, clinical evidence should be sourced from performance studies that have been carried out under the responsibility of a sponsor.
Klinični dokazi bi praviloma morali biti pridobljeni iz študij učinkovitosti, za izvedbo katerih je odgovoren sponzor.
It should be possible both for the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the performance study.
Omogočiti bi bilo treba, da tako proizvajalec kot druga fizična ali pravna oseba opravlja vlogo sponzorja, ki prevzame odgovornost za študijo učinkovitosti.
It is necessary to ensure that the clinical evidence of devices is updated throughout their lifecycle.
Klinične dokaze za pripomočke je treba posodabljati skozi njihovo celotno življenjsko dobo.
Such updating entails the planned monitoring of scientific developments and changes in medical practice by the manufacturer.
To posodabljanje vključuje načrtovano spremljanje znanstvenega napredka in sprememb medicinske prakse proizvajalca.
Relevant new information should then trigger a reassessment of the clinical evidence of the device thus ensuring safety and performance through a continuous process of performance evaluation.
Če se pojavijo pomembne nove informacije, bi se moral začeti postopek ponovnega ocenjevanja kliničnih dokazov pripomočkov, da bi prek nenehnega ocenjevanja učinkovitosti zagotovili varnost in učinkovitost.
It should be recognised that the concept of clinical benefit for in vitro diagnostic medical devices is fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical devices, since the benefit of in vitro diagnostic medical devices lies in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available.
Upoštevati bi bilo treba, da se koncept klinične koristi in vitro diagnostičnih medicinskih pripomočkov bistveno razlikuje od koncepta koristi farmacevtskih ali terapevtskih medicinskih pripomočkov, saj je korist in vitro diagnostičnih medicinskih pripomočkov v tem, da zagotavljajo natančne zdravstvene informacije o pacientih, ki se po potrebi primerjajo z zdravstvenimi informacijami, pridobljenimi z uporabo drugih diagnostičnih možnosti in tehnologij, medtem ko je končni klinični izid za pacienta odvisen od nadaljnjih diagnostičnih in/ali terapevtskih možnosti, ki so morda razpoložljive.