natgillin/translations-raw huggingface dataset:
‘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;
deluje, kot je predvideno, ne da bi izgubil učinkovitost ali da bi bila ta ogrožena, in/ali
‘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:
postane sestavni del in/ali deluje, ne da bi bilo pri tem treba spremeniti ali prilagoditi kateri koli del kombiniranih pripomočkov, in/ali
perform without losing or compromising the ability to perform as intended, and/or
v takšni kombinaciji ne povzroča komplikacij/motenj ali neželenih reakcij;
integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
„interoperabilnost“ pomeni, da dva ali več pripomočkov istega ali različnih proizvajalcev, vključno s programsko opremo, omogoča:
be used together without conflict/interference or adverse reaction.
izmenjavo informacij in uporabo izmenjanih informacij za pravilno izvedbo določene funkcije brez spreminjanja vsebine podatkov in/ali
‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
medsebojno komuniciranje in/ali
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
skupno delovanje, kot je predvideno;
communicate with each other, and/or
„omogočanje dostopnosti na trgu“ pomeni vsako dobavo pripomočka, razen pripomočka, ki je predmet raziskave, za distribucijo, potrošnjo ali uporabo na trgu Unije v okviru poslovne dejavnosti v zameno za plačilo ali brezplačno;
work together as intended.
„dajanje na trg“ pomeni prvo omogočanje dostopnosti pripomočka na trgu Unije, razen pripomočka, ki je predmet raziskave;
‘making available on the market’ means any supply of a device, other than an investigational device, 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;
„dajanje v uporabo“ pomeni fazo, ko je pripomoček, ki ni pripomoček, ki je predmet raziskave, prvič dostopen končnemu uporabniku za uporabo na trgu Unije za predvideni namen;
‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;
„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;
‘putting into service’ means the stage at which a device, other than an investigational device, 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;
„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;
‘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 trademark;
„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;
‘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;
„uvoznik“ pomeni vsako fizično ali pravno osebo s sedežem v Uniji, ki daje pripomoček iz tretje države na trg Unije;
‘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;
„distributer“ pomeni vsako fizično ali pravno osebo v dobavni verigi, ki ni proizvajalec ali uvoznik in ki omogoča dostopnost pripomočka na trgu, dokler ta ni dan v uporabo;
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
„gospodarski subjekt“ pomeni proizvajalca, pooblaščenega predstavnika, uvoznika, distributerja ali osebo iz člena 22(1) in (3);
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
„zdravstvena ustanova“ pomeni organizacijo, katere glavni namen je nega ali zdravljenje pacientov ali promocija javnega zdravja;
‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);
„uporabnik“ pomeni vsakega zdravstvenega delavca ali nestrokovnjaka, ki uporablja pripomoček;
‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
„nestrokovnjak“ pomeni posameznika, ki nima formalne izobrazbe na ustreznem področju zdravstvenega varstva ali medicinske stroke;
‘user’ means any healthcare professional or lay person who uses a device;
„ponovna obdelava“ pomeni postopek, ki se izvaja na uporabljenem pripomočku, da se omogoči njegova varna ponovna uporaba, vključno s čiščenjem, razkuževanjem, sterilizacijo in s tem povezanimi postopki ter preskušanjem in ponovno vzpostavitvijo tehnične in funkcionalne varnosti uporabljenega pripomočka;
‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
„ugotavljanje skladnosti“ pomeni postopek ugotavljanja, ali so zahteve iz te uredbe glede pripomočka izpolnjene;
‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;
„organ za ugotavljanje skladnosti“ pomeni organ, ki kot tretja stran izvaja dejavnosti ugotavljanja skladnosti, vključno z umerjanjem, preskušanjem, certificiranjem in pregledovanjem;
‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
„priglašeni organ“ pomeni organ za ugotavljanje skladnosti, imenovan v skladu s to uredbo;
‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;
„oznaka skladnosti CE“ ali „oznaka CE“ pomeni oznako, s katero proizvajalec izjavlja, da je pripomoček skladen z veljavnimi zahtevami iz te uredbe in druge veljavne harmonizacijske zakonodaje Unije, ki določajo njeno namestitev.
‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
„klinična ocena“ pomeni sistematičen in načrtovan proces neprekinjenega pridobivanja, zbiranja, analiziranja in ocenjevanja kliničnih podatkov, ki se nanašajo na pripomoček, zaradi preverjanja varnosti in učinkovitosti ter kliničnih koristi pripomočka, kadar se ta uporablja, kot je predvidel proizvajalec;
‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;
„klinična raziskava“ pomeni vsako sistematično raziskavo, ki vključuje eno ali več oseb, da se ocenita varnost ali učinkovitost pripomočka;
‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;
„pripomoček, ki je predmet raziskave“ pomeni pripomoček, ki se ocenjuje v klinični raziskavi;
‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;
„načrt klinične raziskave“ pomeni dokument, ki vsebuje utemeljitev in opis ciljev, zasnove, metodologije, spremljanja, statistične obdelave, organizacije in izvajanja klinične raziskave;
‘investigational device’ means a device that is assessed in a clinical investigation;
„klinični podatki“ pomeni podatke o varnosti ali učinkovitosti pripomočka, ki so pridobljeni z njegovo uporabo in iz:
‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;
kliničnih raziskav zadevnega pripomočka;
‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
kliničnih raziskav ali drugih študij podobnih pripomočkov, objavljenih v znanstveni literaturi, za katere je mogoče dokazati enakovrednost z zadevnim pripomočkom;
clinical investigation(s) of the device concerned,
poročil, objavljenih v strokovno pregledani znanstveni literaturi, o drugih kliničnih izkušnjah z zadevnim pripomočkom ali podobnim pripomočkom, za katerega je mogoče dokazati enakovrednost z zadevnim pripomočkom;
clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
klinično relevantnih informacij, pridobljenih z nadzorom po dajanju na trg, zlasti s kliničnim spremljanjem po dajanju na trg;
reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
„sponzor“ pomeni posameznika, podjetje, ustanovo ali organizacijo, ki prevzame odgovornost za začetek, vodenje in pripravo financiranja klinične raziskave;
clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;
„udeleženec“ pomeni posameznika, ki sodeluje v klinični raziskavi;
‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation;
„klinični dokaz“ pomeni klinične podatke o pripomočku in rezultate njegove klinične ocene, ki jih je dovolj in so dovolj kakovostni, da je mogoče kvalificirano oceniti, ali je pripomoček varen in ali dosega predvideno(-e) klinično(-e) korist(i) pri uporabi, kot jo je predvidel proizvajalec;
‘subject’ means an individual who participates in a clinical investigation;
„klinična učinkovitost“ pomeni zmožnost pripomočka, da zaradi neposrednih ali posrednih zdravstvenih učinkov, ki izhajajo iz njegovih tehničnih in funkcionalnih značilnosti, tudi diagnostičnih, ob uporabi, kot jo je predvidel proizvajalec, doseže predvideni namen, kot ga navaja proizvajalec, ter s tem pacientom prinese klinično korist;
‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;
„klinična korist“ pomeni pozitiven učinek pripomočka na zdravje posameznika, izražen kot pomemben in merljiv klinični izid, ki je koristen za pacienta, med drugim izid, povezan z diagnozo, ali pozitiven učinek na obravnavo pacientov ali javno zdravje;
‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;
„raziskovalec“ pomeni posameznika, odgovornega za izvajanje klinične raziskave na mestu izvajanja klinične raziskave;
‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;
„privolitev po seznanitvi“ pomeni, da udeleženec svobodno in prostovoljno izrazi pripravljenost sodelovati v določeni klinični raziskavi, potem ko je bil obveščen o vseh vidikih klinične raziskave, ki so pomembni za njegovo odločitev za sodelovanje, ali, v primeru mladoletnikov ali udeležencev, ki niso sposobni odločati o sebi, dovoljenje ali soglasje njihovega zakonito imenovanega zastopnika, da se jih vključi v klinično raziskavo;
‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;
„odbor za etiko“ pomeni neodvisno telo, ustanovljeno v državi članici v skladu s pravom te države članice, katerega naloga je dajanje mnenj za namene te uredbe, pri katerih upošteva stališča nestrokovnjakov, zlasti pacientov ali organizacij pacientov;
‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;
„neželeni dogodek“ pomeni vsak neugoden medicinski pojav, nenamerno bolezen ali poškodbo ali katere koli neželene klinične znake, vključno z nenormalnimi laboratorijskimi ugotovitvami, ne glede na to, ali so povezani s pripomočkom, ki je predmet raziskave, pri udeležencih, uporabnikih ali drugih osebah v okviru klinične raziskave;
‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;
„resni neželeni dogodek“ pomeni vsak neželeni dogodek, katerega posledica je:
‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;
smrt,
‘serious adverse event’ means any adverse event that led to any of the following:
resno poslabšanje zdravja udeleženca v študiji, posledica česar je kar koli od naslednjega:
death,
življenjsko nevarna bolezen ali poškodba,
serious deterioration in the health of the subject, that resulted in any of the following:
trajna prizadetost telesne strukture ali funkcije,
life-threatening illness or injury,
hospitalizacija ali podaljšanje hospitalizacije pacienta,
permanent impairment of a body structure or a body function,
medicinski ali kirurški poseg za preprečitev življenjsko nevarne bolezni ali poškodbe ali trajne poškodbe telesne strukture ali funkcije,
hospitalisation or prolongation of patient hospitalisation,
kronična bolezen;
medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
stiska ali smrt ploda ali prirojena telesna napaka ali duševna prizadetost ali motnja;
chronic disease,
„pomanjkljivost pripomočka“ pomeni vsako neustreznost glede istovetnosti, kakovosti, trajnosti, zanesljivosti, varnosti ali učinkovitosti pripomočka, ki je predmet raziskave, vključno z okvarami, napakami pri uporabi ali neustreznimi informacijami proizvajalca;
foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
„nadzor po dajanju na trg“ pomeni vse dejavnosti, ki jih izvajajo proizvajalci v sodelovanju z drugimi gospodarskimi subjekti, da vzpostavijo in posodabljajo sistematski postopek za proaktivno zbiranje in pregledovanje izkušenj, pridobljenih s pripomočki, ki jih dajo na trg, katerih dostopnost omogočijo na trgu ali ki jih dajo v uporabo, da bi ugotovili, ali so potrebni takojšnji korektivni ali preventivni ukrepi;
‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer;
„nadzor trga“ pomeni dejavnosti in ukrepe pristojnih organov, ki so namenjeni preverjanju in zagotavljanju, da pripomočki izpolnjujejo zahteve, določene v ustrezni harmonizacijski zakonodaji Unije, in da ne ogrožajo zdravja, varnosti ali katerega koli drugega vidika varovanja javnih interesov;
‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
„odpoklic“ pomeni vsak ukrep za vrnitev pripomočka, katerega dostopnost je bila že omogočena končnemu uporabniku;
‘market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
„umik“ pomeni vsak ukrep za preprečitev nadaljnjega omogočanja dostopnosti pripomočka v dobavni verigi na trgu;
‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;
„zaplet“ pomeni vsako okvaro ali poslabšanje lastnosti ali učinkovitosti pripomočka, ki je dostopen na trgu, tudi zaradi napake ob uporabi, ki je posledica ergonomskih značilnosti, ter vsako neustrezno informacijo proizvajalca in vsak neželen stranski učinek;
‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;
„resni zaplet“ pomeni vsak dogodek, ki neposredno ali posredno povzroči ali bi lahko povzročil:
‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;
smrt pacienta, uporabnika ali druge osebe,
‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
začasno ali trajno resno poslabšanje zdravstvenega stanja pacienta, uporabnika ali druge osebe,
the death of a patient, user or other person,
resno tveganje za javno zdravje;
the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
„resno tveganje za javno zdravje“ pomeni dogodek, katerega posledica je lahko neposredno tveganje smrti, resnega poslabšanja zdravstvenega stanja osebe ali hude bolezni, zaradi česar bi lahko bil potreben takojšen popravni ukrep, in ki lahko povzroči precejšnjo obolevnost ali umrljivost ljudi ali ki je neobičajen ali nepričakovan v določenem kraju in času;
a serious public health threat;
„korektivni ukrep“ pomeni ukrep za odpravo vzroka morebitne ali dejanske neskladnosti ali drugega neželenega stanja;
‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;
„varnostni korektivni ukrep“ pomeni korektivni ukrep, ki ga proizvajalec sprejme iz tehničnih ali zdravstvenih razlogov, da prepreči ali zmanjša tveganje resnega zapleta v zvezi s pripomočkom, ki je dostopen na trgu;
‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;
„obvestilo o varnostnem korektivnem ukrepu“ pomeni sporočilo, ki ga proizvajalec pošlje uporabnikom ali kupcem v zvezi z varnostnim korektivnim ukrepom;
‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;
„harmonizirani standard“ pomeni evropski standard, kakor je opredeljen v točki (1)(c) člena 2 Uredbe (EU) št. 1025/2012;
‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;
„skupne specifikacije“ pomeni sklop tehničnih in/ali kliničnih zahtev in ni standard, temveč sredstvo za izpolnjevanje pravnih obveznosti, ki veljajo za pripomoček, postopek ali sistem.
‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
Člen 3
‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
Spremembe nekaterih opredelitev
Article 3
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115 za spremembo opredelitve nanomateriala iz točke 18 in z njo povezanih opredelitev iz točk 19, 20 in 21 člena 2 glede na tehnični in znanstveni napredek ter ob upoštevanju opredelitev, dogovorjenih na ravni Unije in mednarodni ravni.
Amendment of certain definitions
Člen 4
The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.
Regulativni status izdelkov
Article 4
Brez poseganja v člen 2(2) Direktive 2001/83/ES Komisija na ustrezno utemeljeno zahtevo države članice in po posvetovanju s Koordinacijsko skupino za medicinske pripomočke, ustanovljeno v skladu s členom 103 te uredbe, z izvedbenimi akti določi, ali določen izdelek oziroma kategorija ali skupina izdelkov ustreza opredelitvi „medicinskega pripomočka“ ali „dodatka za medicinski pripomoček“.
Regulatory status of products
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 114(3) te uredbe.
Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’.
Komisija lahko poleg tega na lastno pobudo in po posvetovanju s Koordinacijsko skupino za medicinske pripomočke z izvedbenimi akti odloči o vprašanjih iz odstavka 1 tega člena.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3) of this Regulation.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 114(3).