natgillin/translations-raw huggingface dataset:
However, in order to avoid multiple registrations, economic operators and notified bodies who register in the relevant electronic systems set up at Union level pursuant to this Regulation should be considered to be in compliance with the registration requirements adopted by the Member States pursuant to those provisions.
Za preprečitev podvajanja registracij pa bi moralo za gospodarske subjekte in priglašene organe, ki se registrirajo v ustreznih elektronskih sistemih, vzpostavljenih na ravni Unije na podlagi te uredbe, šteti, da izpolnjujejo zahteve v zvezi z registracijo, ki so jih v skladu z navedenimi določbami sprejele države članice.
Directive 98/79/EC should be repealed to ensure that only one set of rules applies to the placing of in vitro diagnostic medical devices on the market and the related aspects covered by this Regulation.
Direktivo 98/79/ES bi bilo treba razveljaviti za zagotovitev, da se za dajanje in vitro diagnostičnih medicinskih pripomočkov na trg in s tem povezane vidike, ki jih zajema ta uredba, uporablja le en sklop pravil.
Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to that Directive should however continue to apply.
Še naprej pa bi se morale uporabljati obveznosti proizvajalcev v zvezi z omogočanjem dostopnosti dokumentacije o pripomočkih, ki so jih dali na trg, ter obveznosti držav članic v zvezi z dejavnostmi vigilance za pripomočke, dane na trg na podlagi navedene direktive.
While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting adverse incidents related to devices placed on the market pursuant to that Directive using the same tools as those for reporting on devices placed on the market pursuant to this Regulation.
Čeprav bi bilo treba državam članicam prepustiti odločitev, kako bodo organizirale dejavnosti vigilance, je zaželeno, da bi imele možnost poročati o zapletih v zvezi s pripomočki, danimi na trg na podlagi navedene direktive, s pomočjo enakih orodij, kot se uporablja za poročanje v zvezi s pripomočki, danimi na trg na podlagi te uredbe.
However, Decision 2010/227/EU adopted in implementation of that Directive and Council Directives 90/385/EEC [19] and 93/42/EEC [20] should also be repealed as from the date when Eudamed becomes fully functional.
Sklep 2010/227/EU, sprejet za izvajanje navedene direktive ter direktiv Sveta 90/385/EGS [19] in 93/42/EGS [20], bi bilo tudi treba razveljaviti od datuma, ko bo Eudamed postal povsem operativen.
The requirements of this Regulation should be applicable to all devices placed on the market or put into service from the date of application of this Regulation.
Zahteve, določene v tej uredbi, bi se morale uporabljati za vse pripomočke, ki se dajo na trg ali v uporabo od datuma začetka uporabe te uredbe.
However, in order to provide for a smooth transition it should be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by virtue of a valid certificate issued pursuant to Directive 98/79/EC.
Da pa bi zagotovili nemoten prehod, bi v omejenem obdobju po tem datumu morali omogočiti, da se pripomočki dajejo na trg ali v uporabo na podlagi veljavnih certifikatov, izdanih v skladu z Direktivo 98/79/ES.
The European Data Protection Supervisor has given an opinion [21] pursuant to Article 28(2) of Regulation (EC) No 45/2001.
Evropski nadzornik za varstvo podatkov je podal mnenje [21] v skladu s členom 28(2) Uredbe (ES) št. 45/2001.
Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal market as regards medical devices and to ensure high standards of quality and safety for in vitro diagnostic medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker ciljev te uredbe države članice ne morejo zadovoljivo doseči, in sicer zagotoviti nemoteno delovanje notranjega trga za medicinske pripomočke ter visokih standardov kakovosti in varnosti in vitro diagnostičnih medicinskih pripomočkov ter hkrati visoko raven varovanja zdravja in varnosti pacientov, uporabnikov in drugih oseb, temveč se zaradi obsega in učinkov ukrepa lažje dosežejo na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union.
Ta uredba določa pravila za dajanje na trg in vitro diagnostičnih medicinskih pripomočkov in njihovih dodatkov za uporabo v humani medicini, omogočanje njihove dostopnosti na trgu ali njihovo dajanje v uporabo v Uniji.
This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union.
Ta uredba se uporablja tudi za študije glede učinkovitosti teh in vitro diagnostičnih medicinskih pripomočkov in dodatkov, ki se izvajajo v Uniji.
For the purposes of this Regulation, in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices shall hereinafter be referred to as ‘devices’.
In vitro diagnostični medicinski pripomočki in dodatki za in vitro diagnostične medicinske pripomočke se za namene te uredbe imenujejo „pripomočki“.
products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
izdelke za splošno laboratorijsko uporabo ali izdelke, namenjene izključno za uporabo v raziskavah, razen če je proizvajalec posebej predvidel, da se taki izdelki zaradi svojih lastnosti uporabljajo pri in vitro diagnostičnih preiskavah;
invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;
invazivne izdelke za vzorčenje ali izdelke, ki se aplicirajo neposredno na človeško telo za pridobitev vzorca;
internationally certified reference materials;
mednarodno potrjene referenčne materiale;
materials used for external quality assessment schemes.
materiale, ki se uporabljajo za zunanje sisteme ocenjevanja kakovosti.
Any device which, when placed on the market or put into service, incorporates, as an integral part, a medical device as defined in point 1 of Article 2 of Regulation (EU) 2017/745 shall be governed by that Regulation.
Pripomočke, ki ob dajanju na trg ali v uporabo kot sestavni del vsebujejo medicinski pripomoček, kot je opredeljen v točki 1 člena 2 Uredbe (EU) 2017/745, ureja navedena uredba.
The requirements of this Regulation shall apply to the in vitro diagnostic medical device part.
Zahteve iz te uredbe se uporabljajo za del, ki se šteje za in vitro diagnostični medicinski pripomoček.
This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
Ta uredba pomeni posebno zakonodajo Unije v smislu člena 2(3) Direktive 2014/30/EU.
Devices which are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council [22] shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation.
Pripomočki, ki so tudi stroji v smislu točke (a) drugega odstavka člena 2 Direktive 2006/42/ES Evropskega parlamenta in Sveta [22], ob obstoju nevarnosti v smislu navedene direktive izpolnjujejo tudi osnovne zdravstvene in varnostne zahteve iz Priloge 1 k navedeni direktivi, če so te zahteve bolj specifične kot splošne zahteve glede varnosti in učinkovitosti iz poglavja II Priloge I k tej uredbi.
This Regulation shall not affect the application of Directive 2013/59/Euratom.
Ta uredba ne vpliva na uporabo Direktive 2013/59/Euratom.
This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation.
Ta uredba ne posega v pravico države članice, da v zvezi z vidiki, ki niso zajeti v tej uredbi, omeji uporabo specifične vrste pripomočka.
This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or health care institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling.
Ta uredba ne posega v nacionalno pravo glede organizacije, zagotavljanja ali financiranja zdravstvenih storitev in zdravstvene oskrbe, kot so na primer zahteva, v skladu s katero je določene pripomočke mogoče izdati le na naročilnico, zahteva, da lahko samo nekateri zdravstveni delavci ali zdravstvene ustanove izdajajo ali uporabljajo določene pripomočke, ali zahteva, da uporabnik o uporabi teh pripomočkov prejme posebno strokovno svetovanje.
Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union.
Nič v tej uredbi ne omejuje svobode tiska ali svobode izražanja v medijih, kot sta zagotovljeni v Uniji in državah članicah, zlasti na podlagi člena 11 Listine Evropske unije o temeljnih pravicah.
‘medical device’ means ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745;
„medicinski pripomoček“ pomeni medicinski pripomoček, kakor je opredeljen v točki 1 člena 2 Uredbe (EU) 2017/745;
‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
„in vitro diagnostični medicinski pripomoček“ pomeni vsak medicinski pripomoček, ki je reagent, reagenčni izdelek, umerjevalec, kontrolni material, komplet, instrument, aparat, del opreme, programska oprema ali sistem, ki se uporablja sam ali v kombinaciji, proizvajalec pa ga je predvidel za uporabo in vitro za preiskave vzorcev, vključno z darovano krvjo in darovanimi tkivi, pridobljenimi iz človeškega telesa, samo ali v glavnem za pridobivanje ene ali več naslednjih informacij:
concerning a physiological or pathological process or state;
o fiziološkem ali patološkem procesu ali stanju;
concerning congenital physical or mental impairments;
o prirojenih telesnih ali duševnih prizadetostih;
concerning the predisposition to a medical condition or a disease;
o nagnjenosti k bolezenskemu stanju ali bolezni;
to determine the safety and compatibility with potential recipients;
za določanje varnosti in združljivosti z možnimi prejemniki;
to predict treatment response or reactions;
za predvidevanje odzivanja ali reakcij na zdravljenje;
to define or monitoring therapeutic measures.
za opredelitev ali spremljanje terapevtskih ukrepov.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;
Tudi posode za vzorce se štejejo za in vitro diagnostične medicinske pripomočke;
‘specimen receptacle’ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination;
„posoda za vzorce“ pomeni pripomoček, vakuumski ali ne, ki ga je proizvajalec namenil predvsem za to, da vsebuje in hrani vzorce, vzete iz človeškega telesa za namene in vitro diagnostične preiskave;
‘accessory for an in vitro diagnostic medical device’ means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s);
„dodatek za in vitro diagnostični medicinski pripomoček“ pomeni predmet, ki sam sicer ni in vitro diagnostični medicinski pripomoček, vendar ga je njegov proizvajalec namenil za uporabo skupaj z enim ali več posebnimi in vitro diagnostičnimi medicinskimi pripomočki, in izrecno omogoča uporabo in vitro diagnostičnega medicinskega pripomočka ali pripomočkov v skladu z njihovimi predvidenimi nameni ali izrecno in neposredno pripomore k medicinski funkcionalnosti in vitro diagnostičnega medicinskega pripomočka ali pripomočkov z vidika njihovega predvidenega namena;
‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services;
„pripomoček za samotestiranje“ pomeni vsak pripomoček, ki ga je proizvajalec namenil za uporabo nestrokovnjakom, vključno s pripomočki, ki se uporabljajo za storitve testiranja, ki se ponujajo nestrokovnjakom v okviru storitev informacijske družbe;
‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional;
„pripomoček za testiranje ob pacientu“ pomeni vsak pripomoček, ki ni namenjen za samotestiranje, temveč za testiranje zunaj laboratorijskega okolja, ki ga izvaja zdravstveni delavec, običajno blizu pacienta ali ob njem;
‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to:
„dopolnilna diagnostika“ pomeni pripomoček, ki je bistven za varno in učinkovito uporabo ustreznega zdravila, da se:
identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
pred in/ali med zdravljenjem ugotovi, za katere paciente je najbolj verjetno, da jim bo ustrezno zdravilo koristilo, ali
identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product;
pred in/ali med zdravljenjem ugotovi, pri katerih pacientih verjetno obstaja povečano tveganje resnih neželenih učinkov zaradi zdravljenja z ustreznim zdravilom;
‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
„generična skupina pripomočkov“ pomeni skupino pripomočkov, ki imajo enak ali podoben predvideni namen ali skupno tehnologijo, kar jim omogoča, da so razvrščeni na generični način, ki ne odraža specifičnih lastnosti;
‘single-use device’ means a device that is intended to be used during a single procedure;
„pripomoček za enkratno uporabo“ pomeni pripomoček, namenjen uporabi med enim samim postopkom;
‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures.
„ponarejen pripomoček“ pomeni pripomoček, pri katerem so lažno predstavljeni njegova identiteta in/ali vir in/ali certifikati o oznaki CE ali dokumenti, ki se nanašajo na postopke označevanja z oznako CE.
This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;
Ta opredelitev ne zajema nenamernih neskladnosti in ne posega v kršitve pravic intelektualne lastnine;
‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof;
„komplet“ pomeni sestavne dele, ki so skupaj zapakirani in namenjeni za izvedbo specifične in vitro diagnostične preiskave ali dela te preiskave;
‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation;
„predvideni namen“ pomeni uporabo, za katero je pripomoček predviden v skladu s podatki, ki jih navede proizvajalec na oznaki, v navodilih za uporabo ali v promocijskih ali prodajnih gradivih ali izjavah, ali kot jo opredeli proizvajalec v oceni učinkovitosti;
‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;
„oznaka“ pomeni pisne, tiskane ali grafične informacije bodisi na samem pripomočku bodisi na embalaži vsake enote ali na embalaži več pripomočkov;
‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;
„navodila za uporabo“ pomeni informacije, ki jih zagotovi proizvajalec za obveščanje uporabnika o predvidenem namenu in pravilni uporabi pripomočka ter o morebitnih previdnostnih ukrepih, ki se sprejmejo;
‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;
„edinstveni identifikator pripomočka“ („UDI“ – Unique Device Identifier) pomeni zaporedje numeričnih ali alfanumeričnih znakov, ustvarjeno z mednarodno sprejetim standardom identifikacije in kodiranja pripomočka in ki omogoča nedvoumno identifikacijo posameznih pripomočkov na trgu;
‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
„tveganje“ pomeni kombinacijo verjetnosti pojava škode in resnosti te škode;
‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;
„določitev koristi in tveganja“ pomeni analizo vseh ocen koristi in tveganja, ki bi lahko bile relevantne za uporabo pripomočka za predvideni namen, kadar se uporablja v skladu z namenom, ki ga navaja proizvajalec;
‘compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
„kompatibilnost“ pomeni zmožnost pripomočka, tudi programske opreme, da pri uporabi skupaj z enim ali več drugimi pripomočki v skladu z njihovim predvidenim namenom:
perform without losing or compromising the ability to perform as intended, and/or
deluje, kot je predvideno, ne da bi izgubil učinkovitost ali da bi bila ta ogrožena, in/ali
integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
postane sestavni del in/ali deluje, ne da bi bilo pri tem treba spremeniti ali prilagoditi kateri koli del kombiniranih pripomočkov, in/ali
be used together without conflict/interference or adverse reaction;
v takšni kombinaciji ne povzroča komplikacij/motenj ali neželenih reakcij;
‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
„interoperabilnost“ pomeni, da dva ali več pripomočkov istega ali različnih proizvajalcev, vključno s programsko opremo, omogoča:
exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or
izmenjavo informacij in uporabo izmenjanih informacij za pravilno izvedbo določene funkcije brez spreminjanja vsebine podatkov in/ali
communicate with each other, and/or
medsebojno komuniciranje in/ali
work together as intended;
skupno delovanje, kot je predvideno;
‘making available on the market’ means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
„omogočanje dostopnosti na trgu“ pomeni vsako dobavo pripomočka, razen pripomočka za študijo učinkovitosti, za distribucijo, potrošnjo ali uporabo na trgu Unije v okviru poslovne dejavnosti v zameno za plačilo ali brezplačno;
‘placing on the market’ means the first making available of a device, other than a device for performance study, on the Union market;
„dajanje na trg“ pomeni prvo omogočanje dostopnosti pripomočka na trgu Unije, razen pripomočka za študijo učinkovitosti;
‘putting into service’ means the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;
„dajanje v uporabo“ pomeni fazo, ko je pripomoček, ki ni pripomoček za študijo učinkovitosti, prvič dostopen končnemu uporabniku za uporabo na trgu Unije za predvideni namen;
‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;
„proizvajalec“ pomeni fizično ali pravno osebo, ki izdeluje ali popolnoma predela pripomoček ali naroči zasnovo, izdelavo ali popolno predelavo pripomočka in ki ta pripomoček trži pod svojim imenom ali blagovno znamko;
‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;
„popolna predelava“ za namene opredelitve pojma proizvajalca pomeni popolno rekonstrukcijo pripomočka, ki je že bil dan na trg ali v uporabo, ali izdelavo novega pripomočka iz rabljenih pripomočkov, da postane skladen s to uredbo, skupaj z določitvijo nove življenjske dobe za tako predelan pripomoček;
‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
„pooblaščeni predstavnik“ pomeni vsako fizično ali pravno osebo s sedežem v Uniji, ki je prejela in sprejela pisno pooblastilo proizvajalca, ki se nahaja zunaj Unije, da v njegovem imenu izvaja določene naloge v zvezi z obveznostmi tega proizvajalca po tej uredbi;
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
„uvoznik“ pomeni vsako fizično ali pravno osebo s sedežem v Uniji, ki daje pripomoček iz tretje države na trg Unije;