natgillin/translations-raw huggingface dataset:
advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;
kozmetične izdelke, ki jih zajema Uredba (ES) št. 1223/2009;
human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;
organe za presaditev, tkiva ali celice živalskega izvora ali njihove derivate ali izdelke, ki jih vsebujejo ali so iz njih sestavljeni; vendar pa se ta uredba uporablja za pripomočke, izdelane z uporabo tkiv ali celic živalskega izvora ali njihovih derivatov, ki so neviabilni ali so postali neviabilni;
cosmetic products covered by Regulation (EC) No 1223/2009;
organe za presaditev, tkiva ali celice človeškega izvora ali njihove derivate, zajete v Direktivi 2004/23/ES, ali izdelke, ki jih vsebujejo ali so iz njih sestavljeni; vendar pa se ta uredba uporablja za pripomočke, izdelane z uporabo derivatov človeških tkiv ali celic, ki so neviabilni ali so postali neviabilni;
transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable;
izdelke, razen tistih iz točk (d), (f) in (g), ki vsebujejo viabilni biološki material ali viabilne organizme ali so iz njih sestavljeni, vključno z živimi mikroorganizmi, bakterijami, glivami ali virusi, da bi tako dosegli ali podprli predvideni namen izdelka;
transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable;
živila, zajeta v Uredbi (ES) št. 178/2002.
products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;
Ta uredba ureja pripomočke, ki ob dajanju na trg ali v uporabo kot sestavni del vsebujejo in vitro diagnostični medicinski pripomoček, kot je opredeljen v točki 2 člena 2 Uredbe (EU) 2017/746.
food covered by Regulation (EC) No 178/2002.
Zahteve iz Uredbe (EU) 2017/746 se uporabljajo za del pripomočka, ki šteje za in vitro diagnostični medicinski pripomoček.
Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by this Regulation.
Vsak pripomoček se oceni in odobri v skladu s to uredbo, če ob dajanju na trg ali v uporabo kot sestavni del vsebuje snov, ki bi ob ločeni uporabi veljala za zdravilo, kakor je opredeljeno v točki 2 člena 1 Direktive 2001/83/ES, vključno z zdravilom, pridobljenim iz človeške krvi ali plazme, kakor je opredeljeno v točki 10 člena 1 navedene direktive, in ki dopolnjuje učinek zadevnega pripomočka.
The requirements of Regulation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device.
Če pa ima ta snov pri delovanju pripomočka glaven in ne zgolj dopolnilen učinek, celotni izdelek ureja Direktiva 2001/83/ES ali Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta [34], kot je ustrezno.
Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.
V tem primeru se ustrezne splošne zahteve glede varnosti in učinkovitosti iz Priloge I k tej uredbi uporabljajo v zvezi z varnostjo in učinkovitostjo tistega dela, ki šteje za pripomoček.
However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council [34], as applicable.
Vsak pripomoček, namenjen dajanju zdravila, kot je opredeljeno v točki 2 člena 1 Direktive 2001/83/ES, ureja ta uredba brez poseganja v določbe navedene direktive in Uredbe (ES) št. 726/2004 glede zdravila.
In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.
Če sta pripomoček, namenjen dajanju zdravila, in zdravilo dana na trg tako, da tvorita enotni celotni izdelek, ki je namenjen izključno uporabi v dani kombinaciji in ga ni mogoče ponovno uporabiti, ta enotni celotni izdelek ureja Direktiva 2001/83/ES ali Uredba (ES) št. 726/2004, kakor je ustrezno.
Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.
V tem primeru se ustrezne splošne zahteve glede varnosti in učinkovitosti iz Priloge I k tej uredbi uporabljajo v zvezi z varnostjo in učinkovitostjo tistega dela enotnega celotnega izdelka, ki šteje za pripomoček.
However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable.
Vsak pripomoček, ki ob dajanju na trg ali v uporabo kot sestavni del vsebuje neviabilna tkiva ali celice človeškega izvora ali njihove derivate, ki dopolnjujejo učinek zadevnega pripomočka, se oceni in odobri v skladu s to uredbo.
In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.
V tem primeru se uporabljajo določbe o darovanju, pridobivanju in testiranju iz Direktive 2004/23/ES.
Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to that of the device shall be assessed and authorised in accordance with this Regulation.
Če pa imajo ta tkiva ali celice človeškega izvora ali njihovi derivati pri delovanju pripomočka glaven in ne zgolj dopolnilen učinek ter izdelka ne ureja Uredba (ES) št. 1394/2007, ga ureja Direktiva 2004/23/ES.
In that case, the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply.
Ta uredba pomeni posebno zakonodajo Unije v smislu člena 2(3) Direktive 2014/30/EU.
However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC.
Pripomočki, ki so tudi stroji v smislu točke (a) drugega odstavka člena 2 Direktive 2006/42/ES Evropskega parlamenta in Sveta [35], ob obstoju nevarnosti v smislu navedene direktive izpolnjujejo tudi osnovne zdravstvene in varnostne zahteve iz Priloge I 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 is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
Ta uredba ne vpliva na uporabo Direktive 2013/59/Euratom.
Devices that 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 [35] 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.
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 the application of Directive 2013/59/Euratom.
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.
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.
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.
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 healthcare institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling.
Člen 2
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.
Opredelitev pojmov
Article 2
V tej uredbi se uporabljajo naslednje opredelitve pojmov:
Definitions
„medicinski pripomoček“ pomeni vsak instrument, aparat, napravo, programsko opremo, vsadek, reagent, material ali drug predmet, za katerega je proizvajalec predvidel, da se uporablja samostojno ali v kombinaciji za ljudi za enega ali več naslednjih specifičnih medicinskih namenov:
For the purposes of this Regulation, the following definitions apply:
diagnosticiranje, preventivo, spremljanje, predvidevanje, prognozo, zdravljenje ali lajšanje bolezni;
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
diagnosticiranje, spremljanje, zdravljenje, lajšanje poškodb ali invalidnosti ali nadomestilo zanje;
diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
preiskovanje, nadomeščanje ali spreminjanje anatomije ali fiziološkega ali patološkega procesa ali stanja;
diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
pridobivanje informacij z in vitro preiskavami vzorcev, pridobljenih iz človeškega telesa, vključno z darovanimi organi, krvjo in tkivi,
investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
in ki svojega glavnega predvidenega učinka na človeško telo ne dosega na farmakološki, imunološki ali metabolični način, vendar so mu ti procesi v pomoč pri njegovem delovanju.
providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
Tudi naslednji izdelki se štejejo za medicinske pripomočke:
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
pripomočki za nadziranje spočetja ali pomoč pri njem;
The following products shall also be deemed to be medical devices:
izdelki, posebej namenjeni čiščenju, razkuževanju ali sterilizaciji pripomočkov iz člena 1(4) in pripomočkov iz prvega odstavka te točke;
devices for the control or support of conception;
„dodatek za medicinski pripomoček“ pomeni predmet, ki sam sicer ni medicinski pripomoček, vendar ga je njegov proizvajalec namenil za uporabo skupaj z enim ali več posebnimi medicinskimi pripomočki, in izrecno omogoča uporabo medicinskega pripomočka ali pripomočkov v skladu z njihovimi predvidenimi nameni ali izrecno in neposredno pripomore k medicinski funkcionalnosti medicinskega pripomočka ali pripomočkov z vidika njihovega predvidenega namena;
products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
„pripomoček, izdelan za posameznega uporabnika“ pomeni vsak pripomoček, posebej izdelan v skladu z naročilnico katere koli osebe, ki je po nacionalnem pravu pooblaščena zaradi svojih poklicnih kvalifikacij, v kateri so na odgovornost te osebe navedene posebne značilnosti zasnove, in ki je namenjen samo uporabi pri določenem pacientu in izključno za zadovoljitev njegovega osebnega stanja in potreb.
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the 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 medical device(s) in terms of its/their intended purpose(s);
Vendar se masovno proizvedeni pripomočki, ki jih je treba prilagoditi, da bi ustrezali posebnim zahtevam vseh poklicnih uporabnikov, in pripomočki, ki so masovno izdelani z industrijskimi postopki izdelave v skladu z naročilnicami katere koli pooblaščene osebe, ne štejejo za pripomočke, izdelane za posameznega uporabnika;
‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
„aktivni pripomoček“ pomeni vsak pripomoček, katerega delovanje je odvisno od vira energije, ki je v ta namen ne tvori človeško telo ali gravitacija, in ki deluje s spreminjanjem gostote ali pretvarjanjem te energije.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
Pripomočki, ki so namenjeni prenosu energije, snovi ali drugih elementov med aktivnim pripomočkom in pacientom brez konkretne spremembe, se ne štejejo za aktivne pripomočke.
‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.
Tudi programska oprema se šteje za aktivni pripomoček;
Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
„pripomoček za vsaditev“ pomeni vsak pripomoček, vključno s tistimi, ki se delno ali v celoti absorbirajo, ki je namenjen:
Software shall also be deemed to be an active device;
popolni vstavitvi v človeško telo ali
‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
zamenjavi epitelne površine ali površine očesa
to be totally introduced into the human body, or
s kliničnim posegom, pri čemer po opravljenem postopku ostane v telesu.
to replace an epithelial surface or the surface of the eye,
Za pripomoček za vsaditev se šteje tudi vsak pripomoček, ki je namenjen delni vstavitvi v človeško telo s kliničnim posegom in ki po opravljenem postopku ostane v telesu najmanj 30 dni;
by clinical intervention and which is intended to remain in place after the procedure.
„invazivni pripomoček“ pomeni vsak pripomoček, ki delno ali v celoti prodira v notranjost telesa bodisi prek telesne odprtine bodisi skozi površino telesa;
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;
„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;
‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;
„pripomoček za enkratno uporabo“ pomeni pripomoček, namenjen uporabi pri enem posamezniku med enim samim postopkom;
‘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;
„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.
‘single-use device’ means a device that is intended to be used on one individual during a single procedure;
Ta opredelitev ne zajema nenamernih neskladnosti in ne posega v kršitve pravic intelektualne lastnine;
‘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.
„paket“ pomeni kombinacijo izdelkov, ki so pakirani skupaj in dani na trg, da bi bili uporabljeni v specifičen medicinski namen;
This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;
„sistem“ pomeni kombinacijo izdelkov, ki so lahko pakirani skupaj ali ločeno in naj bi v medsebojni povezavi ali kombinaciji dosegli specifičen medicinski namen;
‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;
„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, in kot jo opredeli proizvajalec v klinični oceni;
‘system’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;
„oznaka“ pomeni pisne, tiskane ali grafične informacije bodisi na samem pripomočku bodisi na embalaži vsake enote ali na embalaži več pripomočkov;
‘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 and as specified by the manufacturer in the clinical evaluation;
„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;
‘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;
„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;
‘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;
„neviabilen“ pomeni brez potenciala za metabolizem ali razmnoževanje;
‘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;
„derivat“ pomeni „necelično snov“, ekstrahirano iz človeških ali živalskih tkiv ali celic v postopku izdelave.
‘non-viable’ means having no potential for metabolism or multiplication;
Končna snov, ki se uporabi za izdelavo pripomočka, v tem primeru ne vsebuje celic ali tkiv;
‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process.
„nanomaterial“ pomeni naraven, naključno nastal ali proizveden material, ki vsebuje delce v nevezanem stanju ali v obliki agregata ali aglomerata in pri katerem ima najmanj 50 % delcev, porazdeljenih po velikosti glede na število, eno ali več zunanjih mer v razponu velikosti 1–100 nm.
The final substance used for manufacturing of the device in this case does not contain any cells or tissues;
Za nanomateriale štejejo tudi fulereni, plasti grafena in enostenske ogljikove nanocevke z eno ali več zunanjimi merami pod 1 nm;
‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;
„delec“ za namene opredelitve nanomateriala pod točko 18 pomeni zelo majhen del snovi, ki ima določene fizične meje;
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;
„aglomerat“ za namene opredelitve nanomateriala pod točko 18 pomeni skupek šibko vezanih delcev ali agregatov, katerih zunanja površina je podobna vsoti površin posameznih sestavnih delov;
‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries;
„agregat“ za namene opredelitve nanomateriala pod točko 18 pomeni delec, sestavljen iz močno povezanih ali zlitih delcev;
‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;
„učinkovitost“ pomeni zmožnost pripomočka, da doseže predvideni namen, kot ga navaja proizvajalec;
‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;
„tveganje“ pomeni kombinacijo verjetnosti pojava škode in resnosti te škode;
‘performance’ means the ability of a device to achieve its intended purpose as stated 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 s predvidenim namenom, ki ga navaja proizvajalec;
‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
„kompatibilnost“ pomeni zmožnost pripomočka, tudi programske opreme, da pri uporabi skupaj z enim ali več drugimi pripomočki v skladu z njihovim predvidenim namenom: