natgillin/translations-raw huggingface dataset:
‘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;
„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;
‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
„gospodarski subjekt“ pomeni proizvajalca, pooblaščenega predstavnika, uvoznika ali distributerja;
‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
„zdravstvena ustanova“ pomeni organizacijo, katere glavni namen je nega ali zdravljenje pacientov ali promocija javnega zdravja;
‘user’ means any healthcare professional or lay person who uses a device;
„uporabnik“ pomeni vsakega zdravstvenega delavca ali nestrokovnjaka, ki uporablja pripomoček;
‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
„nestrokovnjak“ pomeni posameznika, ki nima formalne izobrazbe na ustreznem področju zdravstvenega varstva ali medicinske stroke;
‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
„ugotavljanje skladnosti“ pomeni postopek ugotavljanja, ali so zahteve iz te uredbe glede pripomočka izpolnjene;
‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;
„organ za ugotavljanje skladnosti“ pomeni organ, ki kot tretja stran izvaja dejavnosti ugotavljanja skladnosti, vključno z umerjanjem, preskušanjem, certificiranjem in pregledovanjem;
‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
„priglašeni organ“ pomeni organ za ugotavljanje skladnosti, imenovan v skladu s to uredbo;
‘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;
„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.
‘clinical evidence’ means clinical data and performance 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;
„klinični dokaz“ pomeni klinične podatke o pripomočku in rezultate njegove ocene učinkovitosti, 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;
‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;
„klinična korist“ pomeni pozitiven učinek pripomočka v zvezi z njegovim delovanjem, kot je na primer presejanje, spremljanje, diagnosticiranje ali pomoč pri diagnosticiranju pacientov, ali pozitiven učinek na obravnavo pacientov ali javno zdravje;
‘scientific validity of an analyte’ means the association of an analyte with a clinical condition or a physiological state;
„znanstvena veljavnost analita“ pomeni povezavo analita s kliničnim ali fiziološkim stanjem;
‘performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer.
„učinkovitost pripomočka“ pomeni zmožnost pripomočka, da doseže svoj predvideni namen, kot ga navaja proizvajalec.
It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose;
Sestavljata jo analitska in po potrebi klinična učinkovitost, ki dokazujeta ta predvideni namen;
‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte;
„analitska učinkovitost“ pomeni zmožnost pripomočka, da pravilno odkrije ali izmeri določen analit;
‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;
„klinična učinkovitost“ pomeni zmožnost pripomočka, da zagotovi rezultate, ki so povezani z določenim kliničnim ali fiziološkim stanjem ali patološkim procesom ali stanjem v skladu s ciljno populacijo in predvidenim uporabnikom;
‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;
„študija učinkovitosti“ pomeni študijo, izvedeno za ugotavljanje ali potrjevanje analitične ali klinične učinkovitosti pripomočka;
‘performance study plan’ means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study;
„načrt študije učinkovitosti“ pomeni dokument, ki vsebuje utemeljitev in opis ciljev, zasnove, metodologije, spremljanja, statistične obdelave, organizacije in izvajanja študije učinkovitosti;
‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;
„ocena učinkovitosti“ pomeni oceno in analizo podatkov za ugotavljanje ali preverjanje znanstvene veljavnosti, analitske in po potrebi klinične učinkovitosti pripomočka;
‘device for performance study’ means a device intended by the manufacturer to be used in a performance study.
„pripomoček za študijo učinkovitosti“ pomeni pripomoček, za katerega je proizvajalec predvidel, da bo uporabljen v študiji učinkovitosti.
A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study;
Pripomoček, ki je namenjen uporabi v raziskovalne namene in nima nobenega medicinskega namena, se ne šteje za pripomoček za študijo učinkovitosti;
‘interventional clinical performance study’ means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment;
„intervencijska študija klinične učinkovitosti“ pomeni študijo klinične učinkovitosti, pri kateri lahko rezultati testov vplivajo na odločitve o obravnavanju pacienta in/ali se uporabijo za izbiro zdravljenja;
‘subject’ means an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes;
„udeleženec“ pomeni posameznika, ki sodeluje v študiji učinkovitosti in katerega vzorec ali vzorci se s pripomočkom za študijo učinkovitosti in/ali pripomočkom, ki se uporablja za kontrolo, pregledajo s postopkom in vitro;
‘investigator’ means an individual responsible for the conduct of a performance study at a performance study site;
„raziskovalec“ pomeni posameznika, odgovornega za izvajanje študije učinkovitosti na mestu izvajanja študije učinkovitosti;
‘diagnostic specificity’ means the ability of a device to recognise the absence of a target marker associated with a particular disease or condition;
„diagnostična specifičnost“ pomeni zmožnost pripomočka, da prepozna odsotnost ciljnega označevalca, povezanega s posamezno boleznijo ali stanjem;
‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker associated with a particular disease or condition;
„diagnostična občutljivost“ pomeni zmožnost pripomočka, da identificira prisotnost ciljnega označevalca, povezanega s posamezno boleznijo ali stanjem;
‘predictive value’ means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition;
„napovedna vrednost“ pomeni verjetnost, da ima oseba s pozitivnim rezultatom testa s pripomočkom določeno bolezensko stanje, ki je predmet raziskave, ali da oseba z negativnim rezultatom testa s pripomočkom nima določenega bolezenskega stanja;
‘positive predictive value’ means the ability of a device to separate true positive results from false positive results for a given attribute in a given population;
„pozitivna napovedna vrednost“ pomeni zmožnost pripomočka, da loči prave pozitivne rezultate od lažno pozitivnih rezultatov za dano značilnost v določeni populaciji;
‘negative predictive value’ means the ability of a device to separate true negative results from false negative results for a given attribute in a given population;
„negativna napovedna vrednost“ pomeni zmožnost pripomočka, da loči prave negativne rezultate od lažno negativnih rezultatov za dano značilnost v določeni populaciji;
‘likelihood ratio’ means the likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state;
„verjetnostno razmerje“ pomeni verjetnost, da je določen rezultat mogoče pričakovati pri posamezniku s ciljnim kliničnim ali fiziološkim stanjem, v primerjavi z verjetnostjo, da bi se enak rezultat lahko pričakoval pri posamezniku brez navedenega kliničnega ali fiziološkega stanja;
‘calibrator’ means a measurement reference material used in the calibration of a device;
„umerjevalec“ pomeni material za mersko referenco, ki se uporablja pri umerjanju naprave;
‘control material’ means a substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device;
„kontrolni material“ pomeni snov, material ali predmet, ki ga je proizvajalec predvidel za preverjanje učinkovitosti pripomočka;
‘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 performance study;
„sponzor“ pomeni posameznika, podjetje, ustanovo ali organizacijo, ki prevzame odgovornost za začetek, vodenje in za pripravo financiranja študije učinkovitosti;
‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study 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 performance study;
„privolitev po seznanitvi“ pomeni, da udeleženec svobodno in prostovoljno izrazi pripravljenost sodelovati v določeni študiji učinkovitosti, potem ko je bil obveščen o vseh vidikih študije učinkovitosti, 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 študijo učinkovitosti;
‘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;
„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;
‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision, 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 performance study, whether or not related to the device for performance study;
„neželeni dogodek“ pomeni vsak neugoden medicinski pojav, neustrezno odločitev za obravnavanje pacienta, nenamerno bolezen ali poškodbo ali katere koli neželene klinične znake, vključno z nenormalnimi laboratorijskimi ugotovitvami, ne glede na to, ali so povezani s pripomočkom za študijo učinkovitosti, pri udeležencih, uporabnikih ali drugih osebah v okviru študije učinkovitosti;
‘serious adverse event’ means any adverse event that led to any of the following:
„resni neželeni dogodek“ pomeni vsak neželeni dogodek, katerega posledica je:
a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring,
odločitev za obravnavanje pacienta, zaradi katere je testirani posameznik ali posameznikov potomec umrl ali je v neposredno življenjsko nevarnem položaju,
death,
smrt,
serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following:
resno poslabšanje zdravja testiranega posameznika ali prejemnika testiranih darovanj ali materialov, posledica česar je kar koli od naslednjega:
life-threatening illness or injury,
življenjsko nevarna bolezen ali poškodba,
permanent impairment of a body structure or a body function,
trajna prizadetost telesne strukture ali funkcije,
hospitalisation or prolongation of patient hospitalisation,
hospitalizacije ali podaljšanje hospitalizacije pacienta,
medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to 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,
chronic disease,
kronična bolezen;
foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
stiska ali smrt ploda ali prirojena telesna napaka ali duševna prizadetost ali motnja;
‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer;
„pomanjkljivost pripomočka“ pomeni vsako neustreznost glede istovetnosti, kakovosti, trajnosti, zanesljivosti, varnosti ali učinkovitosti pripomočka za študijo učinkovitosti, vključno z okvarami, napakami pri uporabi ali neustreznimi informacijami proizvajalca;
‘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;
„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;
‘market surveillance’ means the activities carried out and measures taken by public 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;
„nadzor trga“ pomeni dejavnosti in ukrepe javnih 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;
‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;
„odpoklic“ pomeni vsak ukrep za vrnitev pripomočka, katerega dostopnost je bila že omogočena končnemu uporabniku;
‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;
„umik“ pomeni vsak ukrep za preprečitev nadaljnjega omogočanja dostopnosti pripomočka v dobavni verigi na trgu;
‘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 harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device;
„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 vsako škodo, ki je posledica medicinske odločitve ali ukrepa, izvedenega ali neizvedenega na podlagi informacij ali rezultatov, pridobljenih s pripomočkom;
‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
„resni zaplet“ pomeni vsak dogodek, ki neposredno ali posredno povzroči ali bi lahko povzročil:
the death of a patient, user or other person,
smrt pacienta, uporabnika ali druge osebe,
the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
začasno ali trajno resno poslabšanje zdravstvenega stanja pacienta, uporabnika ali druge osebe,
a serious public health threat;
resno tveganje za javno zdravje;
‘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;
„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;
‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;
„korektivni ukrep“ pomeni ukrep za odpravo vzroka morebitne ali dejanske neskladnosti ali drugega neželenega stanja;
‘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;
„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;
‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;
„obvestilo o varnostnem korektivnem ukrepu“ pomeni sporočilo, ki ga proizvajalec pošlje uporabnikom ali kupcem v zvezi z varnostnim korektivnim ukrepom;
‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
„harmonizirani standard“ pomeni evropski standard, kakor je opredeljen v točki (1)(c) člena 2 Uredbe (EU) št. 1025/2012;
‘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.
„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.
Regulatory status of products and counselling
Regulativni status izdelkov in svetovanje
Regulatory status of products
Regulativni status izdelkov
Upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of Regulation (EU) 2017/745 (MDCG), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘in vitro diagnostic medical device’ or ‘accessory for an in vitro diagnostic medical device’.
Komisija na ustrezno utemeljeno zahtevo države članice in po posvetovanju s Koordinacijsko skupino za medicinske pripomočke, ustanovljeno v skladu s členom 103 Uredbe (EU) 2017/745, z izvedbenimi akti določi, ali določen izdelek oziroma kategorija ali skupina izdelkov ustreza opredelitvi „in vitro diagnostičnega medicinskega pripomočka“ ali „dodatka za in vitro diagnostični medicinski pripomoček“.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3) of this Regulation.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 107(3) te uredbe.
The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article.
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 107(3).
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 107(3).
The Commission shall ensure that Member States share expertise in the fields of in vitro diagnostic medical devices, medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products.
Komisija zagotovi izmenjavo strokovnega znanja med državami članicami na področju in vitro diagnostičnih medicinskih pripomočkov, medicinskih pripomočkov, zdravil, človeških tkiv in celic, kozmetičnih izdelkov, biocidov, živil in po potrebi drugih izdelkov, da tako določi ustrezen regulativni status izdelka oziroma kategorije ali skupine izdelkov.
When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant.
Pri odločanju o možnem regulativnem statusu kot pripomoček za izdelke, ki vključujejo zdravila, človeška tkiva in celice, biocide ali živila, Komisija zagotovi primerno raven posvetovanja z Evropsko agencijo za zdravila (EMA), Evropsko agencijo za kemikalije in Evropsko agencijo za varnost hrane, kakor je ustrezno.
Genetic information, counselling and informed consent
Genetske informacije, svetovanje in privolitev po seznanitvi