natgillin/translations-raw huggingface dataset:
Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and shall thereafter keep the information updated.
Komisija v skladu s členom 9(1) do 26. maja 2020 sprejme potrebne skupne specifikacije iz točke (b) odstavka 3.
The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018.
Te skupne specifikacije so skladne z najnovejšimi znanstvenimi dokazi in zadevajo uporabo splošnih zahtev glede varnosti in učinkovitosti, določenih v tej uredbi.
That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2020 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met.
Proizvajalec, preden da pripomoček, ki ni pripomoček, izdelan za posameznega uporabnika, na trg, v Eudamed vnese, oziroma če so že vnesene, preveri, informacije iz oddelka 2 dela A Priloge VI, razen njegovega oddelka 2.2, in jih potem redno posodablja.
In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
da se pripomoček oziroma kategorija ali skupina pripomočkov zaradi javnega zdravja ponovno razvrstijo na podlagi novih znanstvenih dokazov ali informacij, ki se pojavijo med vigilanco in dejavnostmi nadzora trga, z odstopanjem od Priloge VIII.
The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Komisija lahko na lastno pobudo in po posvetovanju s Koordinacijsko skupino za medicinske pripomočke z izvedbenimi akti odloči o vprašanjih iz točk (a) in (b) odstavka 3.
SECTION 2
Da se zagotovi enotna uporaba Priloge VIII, in upoštevajo ustrezna znanstvena mnenja ustreznih znanstvenih odborov, lahko Komisija sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe.
Conformity assessment
Izvedbeni akti iz odstavkov 3, 4 in 5 tega člena se sprejmejo v skladu s postopkom pregleda iz člena 114(3).
Regulation (EU) 2017/746 of the European Parliament and of the Council
Uredba (EU) 2017/746 Evropskega parlamenta in Sveta
on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
o in vitro diagnostičnih medicinskih pripomočkih ter razveljavitvi Direktive 98/79/ES in Sklepa Komisije 2010/227/EU
Directive 98/79/EC of the European Parliament and of the Council [3] constitutes the Union regulatory framework for in vitro diagnostic medical devices.
Direktiva 98/79/ES Evropskega parlamenta in Sveta [3] je regulativni okvir Unije za in vitro diagnostične medicinske pripomočke.
However, a fundamental revision of that Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation.
Vendar je za vzpostavitev trdnega, preglednega, predvidljivega in trajnostnega regulativnega okvira za in vitro diagnostične medicinske pripomočke, ki bo zagotavljal visoko stopnjo varnosti in zdravja ter hkrati podpiral inovacije, potrebna temeljita revizija navedene direktive.
This Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector.
Cilj te uredbe je, temelječ na visoki ravni varovanja zdravja pacientov in uporabnikov ter upoštevajoč mala in srednja podjetja, dejavna v tem sektorju, zagotoviti nemoteno delovanje notranjega trga za in vitro diagnostične medicinske pripomočke.
At the same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such products.
Ta uredba določa tudi visoke standarde kakovosti in varnosti in vitro diagnostičnih medicinskih pripomočkov, da bi tako zadostili skupnim potrebam po varnosti teh izdelkov.
Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other.
Oba cilja, ki se ju bo poskušalo doseči hkrati, sta neločljivo povezana in nobeden od njiju ni drugotnega pomena.
As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods.
V zvezi s členom 114 Pogodbe o delovanju Evropske unije (PDEU), ta uredba harmonizira pravila za dajanje in vitro diagnostičnih medicinskih pripomočkov in njihovih dodatkov na trg Unije in v uporabo v njej, zato se bo zanje lahko uporabljalo načelo prostega pretoka blaga.
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices by ensuring, among other things, that data generated in performance studies are reliable and robust and that the safety of subjects participating in performance studies is protected.
V zvezi s členom 168(4)(c) PDEU, ta uredba določa visoke standarde kakovosti in varnosti in vitro diagnostičnih medicinskih pripomočkov ter v ta namen med drugim zagotavlja zanesljivost in ponovljivost podatkov, pridobljenih v študijah učinkovitosti, ter ščiti varnost udeležencev v študijah učinkovitosti.
This Regulation does not seek to harmonise rules relating to the further making available on the market of in vitro diagnostic medical devices after they have already been put into service, such as in the context of second-hand sales.
Ta uredba ne harmonizira pravil, ki se nanašajo na nadaljnje omogočanje dostopnosti in vitro diagnostičnih medicinskih pripomočkov na trgu, potem ko so že bili dani v uporabo, na primer v smislu prodaje rabljenih pripomočkov.
Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices should be introduced, to improve health and safety.
Za višjo raven zdravja in varnosti bi bilo treba bistveno okrepiti ključne elemente obstoječega regulativnega pristopa, kot so nadzor priglašenih organov, razvrščanje v razred tveganja, postopki ugotavljanja skladnosti, ocena učinkovitosti in študije učinkovitosti, vigilanca in nadzor trga, ter vključiti določbe, ki bi zagotovile preglednost in sledljivost in vitro diagnostičnih medicinskih pripomočkov.
To the extent possible, guidance developed for in vitro diagnostic medical devices at international level, in particular in the context of the Global Harmonization Task Force and its follow-up initiative, the International Medical Devices Regulators Forum, should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical evidence.
Za promocijo mednarodne usklajenosti ureditev, ki prispeva k visoki stopnji zaščite varnosti po svetu, in za spodbujanje trgovine, bi bilo treba kar se da upoštevati na mednarodni ravni pripravljene smernice za in vitro diagnostične medicinske pripomočke, zlasti v okviru delovne skupine za svetovno usklajevanje (Global Harmonization Task Force – GHTF) in njene nadaljnje pobude, tj. mednarodnega foruma regulativnih organov na področju medicinskih pripomočkov (International Medical Devices Regulators Forum –IMDRF), zlasti v določbah o edinstveni identifikaciji pripomočka, splošnih zahtevah glede varnosti in učinkovitosti, tehnični dokumentaciji, pravilih za razvrščanje, postopkih ugotavljanja skladnosti ter kliničnih dokazih.
There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned.
Zaradi posebnih značilnosti tako in vitro diagnostičnih medicinskih pripomočkov, zlasti v zvezi z razvrščanjem v razred tveganja, postopki ugotavljanja skladnosti in kliničnimi dokazi, kot sektorja in vitro diagnostičnih medicinskih pripomočkov je treba sprejeti posebno zakonodajo, ki se razlikuje od zakonodaje o drugih medicinskih pripomočkih, obenem pa bi bilo treba uskladiti horizontalne vidike, skupne obema sektorjema.
The scope of application of this Regulation should be clearly delimited from other legislation concerning products, such as medical devices, general laboratory products and products for research use only.
Področje uporabe te uredbe bi bilo treba jasno razmejiti od druge zakonodaje o izdelkih, kot so medicinski pripomočki, splošni laboratorijski izdelki in izdelki, namenjeni samo za raziskave.
It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation.
Države članice bi morale biti odgovorne, da za vsak posamezni primer odločijo, ali izdelek spada v področje uporabe te uredbe.
In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation.
Da bi zagotovili dosledno tovrstno odločanje v vseh državah članicah, zlasti glede mejnih primerov, bi morala imeti Komisija možnost, da na svojo pobudo ali ustrezno utemeljeno zahtevo države članice ter po posvetovanju s Koordinacijsko skupino za medicinske pripomočke (Medical Device Coordination Group – MDCG) za vsak posamezni primer odloči, ali določen izdelek, kategorija ali skupina izdelkov spada v področje uporabe te uredbe.
When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority, as relevant.
Pri odločanju o regulativnem statusu izdelkov iz skupine mejnih primerov, ki vključujejo zdravila, človeška tkiva in celice, biocide ali živila, bi Komisija morala zagotoviti ustrezno raven posvetovanja z Evropsko agencijo za zdravila, Evropsko agencijo za kemikalije in Evropsko agencijo za varnost hrane, kakor je ustrezno.
It appears that it is possible that divergent national rules regarding the provision of information and counselling in relation to genetic testing might only have an impact on the smooth functioning of the internal market to a limited extent.
Zdi se, da bi različni nacionalni predpisi glede informiranja in svetovanja v zvezi z genetskim testiranjem morda le v manjši meri motili nemoteno delovanje notranjega trga.
Therefore, it is appropriate to lay down only limited requirements in this regard in this Regulation, having regard to the need to ensure constant respect of the principles of proportionality and subsidiarity.
Zato je ob upoštevanju potrebe po nenehnem spoštovanju načel sorazmernosti in subsidiarnosti ustrezno v tej uredbi določiti le omejene zahteve v ta namen.
It should be made clear that all tests that provide information on the predisposition to a medical condition or a disease, such as genetic tests, and tests that provide information to predict treatment response or reactions, such as companion diagnostics, are in vitro diagnostic medical devices.
Pojasniti bi bilo treba, da se vsi testi za pridobivanje informacij o nagnjenosti k bolezenskemu stanju ali bolezni, kot na primer genetski testi, in testi za pridobivanje informacij o predvidenih odzivih ali reakcijah na zdravljenje, kot je dopolnilna diagnostika, štejejo za in vitro diagnostične medicinske pripomočke.
Companion diagnostics are essential for defining patients' eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at a higher risk of developing an adverse reaction to the medicinal product in question or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective.
Dopolnilna diagnostika je bistvena za določitev pacientov, ki so primerni za posebno zdravljenje z zdravilom, s kvantitativnim ali kvalitativnim določanjem specifičnih označevalcev, s katerimi se ugotavlja, pri katerih udeležencih obstaja večje tveganje za razvoj neželenih reakcij na zadevno zdravilo ali pri katerih pacientih iz populacije je bil terapevtski izdelek ustrezno preučen ter je bilo zanj ugotovljeno, da je varen in učinkovit.
Such biomarker or biomarkers can be present in healthy subjects and/or in patients.
Taki biološki označevalci so lahko prisotni pri zdravih udeležencih in/ali pacientih.
Devices that are used with a view to monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be companion diagnostics.
Pripomočki, ki se uporabljajo za spremljanje zdravljenja z zdravilom in ki koncentracijo relevantnih snovi v človeškem telesu ohranjajo v terapevtskem oknu, ne štejejo za dopolnilno diagnostiko.
The requirement to reduce risks as far as possible should be fulfilled taking into account the generally acknowledged state of the art in the field of medicine.
Izpolniti bi bilo treba zahtevo po čim večjem zmanjšanju tveganj ob upoštevanju splošno priznanega zadnjega stanja tehničnega razvoja na področju medicine.
Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council [4] are an integral part of the general safety and performance requirements laid down in this Regulation for devices.
Varnostni vidiki iz Direktive 2014/30/EU Evropskega parlamenta in Sveta [4] so sestavni del splošnih zahtev glede varnosti in učinkovitosti pripomočkov, ki so določene v tej uredbi.
Consequently, this Regulation should be considered a lex specialis in relation to that Directive.
Zato bi bilo treba to uredbo obravnavati kot lex specialis glede na navedeno direktivo.
This Regulation should include requirements regarding the design and manufacture of devices emitting ionizing radiation without affecting the application of Council Directive 2013/59/Euratom [5] which pursues other objectives.
V to uredbo bi morali vključiti zahteve glede zasnove in izdelave pripomočkov, ki oddajajo ionizirajoče sevanje, ne da bi to vplivalo na uporabo Direktive Sveta 2013/59/Euratom [5], ki ima drugačne cilje.
This Regulation should include requirements for devices' safety and performance characteristics which are developed in such a way as to prevent occupational injuries, including protection from radiation.
V to uredbo bi morali vključiti zahteve glede varnosti in učinkovitosti pripomočkov, ki so razviti tako, da se preprečijo poškodbe pri delu, kar vključuje tudi zaščito pred sevanjem.
It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic medical device, qualifies as an in vitro diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being purposes is not an in vitro diagnostic medical device.
Pojasniti je treba, da programska oprema sama, kadar jo proizvajalec posebej nameni za uporabo za enega ali več medicinskih namenov iz opredelitve in vitro diagnostičnega medicinskega pripomočka, šteje za in vitro diagnostični medicinski pripomoček, medtem ko programska oprema za splošne namene, tudi kadar se uporablja v zdravstvu, ali programska oprema za namene dobrega počutja ne šteje za in vitro diagnostični medicinski pripomoček.
The definitions in this Regulation regarding the devices themselves, the making available of devices, economic operators, users and specific processes, the conformity assessment, clinical evidence, post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should be aligned with well-established practice in the field at Union and international level in order to enhance legal certainty.
Zaradi večje pravne varnosti bi bilo treba opredelitve v tej uredbi, ki se nanašajo na pripomočke same, omogočanje dostopnosti pripomočkov, gospodarske subjekte, uporabnike in posebne postopke, ugotavljanje skladnosti, klinične dokaze, nadzor po dajanju na trg, vigilanco in nadzor trga, standarde in druge tehnične specifikacije, uskladiti z uveljavljeno področno prakso na ravni Unije in mednarodni ravni.
It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council [6] and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.
Pojasniti bi bilo treba, da morajo pripomočki, ki so osebam v Uniji na voljo prek storitev informacijske družbe v smislu Direktive (EU) 2015/1535 Evropskega parlamenta in Sveta [6], in pripomočki, ki se uporabljajo pri komercialni dejavnosti, katerih namen je zagotovitev diagnostične ali terapevtske storitve osebam v Uniji, izpolnjevati zahteve iz te uredbe, ko se zadevni izdelek da na trg ali ko se storitev začne opravljati v Uniji.
To recognise the important role of standardisation in the field of in vitro diagnostic medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council [7] should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation.
Z izpolnjevanjem harmoniziranih standardov, opredeljenih v Uredbi (EU) št. 1025/2012 Evropskega parlamenta in Sveta [7], bi proizvajalci lahko dokazali, da izpolnjujejo splošne zahteve glede varnosti in učinkovitosti ter druge pravne zahteve, določene v tej uredbi, na primer v zvezi z vodenjem kakovosti in obvladovanjem tveganja, s čimer bi se priznala pomembna vloga standardizacije na področju in vitro diagnostičnih medicinskih pripomočkov.
Directive 98/79/EC allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices.
Direktiva 98/79/ES Komisiji omogoča, da sprejme skupne tehnične specifikacije za posebne kategorije in vitro diagnostičnih medicinskih pripomočkov.
In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance requirements and the requirements for performance studies and performance evaluation and/or post-market follow-up, laid down in this Regulation.
Na Komisijo bi bilo treba prenesti pooblastilo, da na področjih, kjer ni harmoniziranih standardov ali so ti nezadostni, določi skupne specifikacije za izpolnjevanje splošnih zahtev glede varnosti in učinkovitosti ter zahtev glede študij učinkovitosti in ocene učinkovitosti in/ali spremljanja po dajanju na trg, ki so določene v tej uredbi.
Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and taking account of the European and international standards.
Skupne specifikacije bi morali pripraviti po posvetovanju z zadevnimi deležniki ter pri tej pripravi upoštevati evropske in mednarodne standarde.
The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the Council [8] and Decision No 768/2008/EC of the European Parliament and of the Council [9].
Pravila, ki se uporabljajo za pripomočke, bi bilo treba, kjer je to primerno, uskladiti z novim zakonodajnim okvirom za trženje proizvodov, ki ga sestavljata Uredba (ES) št. 765/2008 Evropskega parlamenta in Sveta [8] in Sklep št. 768/2008/ES Evropskega parlamenta in Sveta [9].
The rules on Union market surveillance and control of products entering the Union market laid down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks.
Pravila za nadzor trga Unije in spremljanje izdelkov, ki vstopajo na trg Unije, določena v Uredbi (ES) št. 765/2008, se uporabljajo za pripomočke, ki jih zajema ta uredba, kar pa državam članicam ne preprečuje, da imenujejo organe, pristojne za izvajanje navedenih nalog.
Several of the obligations on manufacturers, such as performance evaluation or vigilance reporting, that were set out only in the Annexes to Directive 98/79/EC, should be incorporated into the enacting provisions of this Regulation to facilitate its application.
Več obveznosti proizvajalcev, kot sta ocena učinkovitosti ali poročanje o vigilanci, ki so določene samo v prilogah k Direktivi 98/79/ES, bi bilo treba vključiti v normativne določbe te uredbe, da bi se tako lahko lažje uporabljala.
To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices, manufactured and used within a single health institution only, should be clarified and strengthened.
Za zagotovitev najvišje ravni varovanja zdravja bi bilo treba razjasniti in okrepiti pravila, ki veljajo za in vitro diagnostične medicinske pripomočke, ki so izdelani in se uporabljajo v eni zdravstveni ustanovi.
That use should be understood to include measurement and delivery of results.
To bi moralo vključevati meritve in dosežene rezultate.
Health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby addressing, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market.
Zdravstvene ustanove bi morale imeti možnost, da v sami ustanovi proizvajajo, spreminjajo in uporabljajo pripomočke in se tako na neindustrijski ravni odzovejo na posebne potrebe ciljnih skupin pacientov, ki jih ni mogoče dovolj učinkovito zadovoljiti z enakovrednim pripomočkom, dostopnim na trgu.