natgillin/translations-raw huggingface dataset:
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
„medicinski pripomoček“ pomeni vsak instrument, aparaturo, napravo, programsko opremo, material ali drug predmet, ki se uporablja samostojno ali v kombinaciji, vključno s programsko opremo, ki jo je proizvajalec predvidel izrecno za uporabo za diagnostiko in/ali v terapevtske namene in je potrebna za njegovo pravilno uporabo, ki ga je proizvajalec predvidel za uporabo na ljudeh z namenom:
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
diagnostike, spremljanja, zdravljenja, lajšanja ali nadomestila za poškodbe ali okvare,
investigation, replacement or modification of the anatomy or of a physiological process,
preiskovanja, nadomeščanja ali spreminjanja anatomije ali fizioloških procesov,
control of conception,
nadzora spočetja,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means [11];
in ki svojega glavnega predvidenega učinka na človeško telo ne dosega s farmakološkimi, imunološkimi ali presnovnimi sredstvi, vendar pa so mu lahko ta sredstva pri njegovem delovanju v pomoč [11];
‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure [12];
„aktivni medicinski pripomoček za vsaditev“ je aktivni medicinski pripomoček, ki je namenjen, da se v celoti ali delno, kirurško ali zdravstveno vsadi v človeško telo ali da se z zdravstvenim posegom vstavi v naravno odprtino in po takem postopku tam ostane [12];
‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment 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:
„in vitro diagnostični medicinski pripomoček“ pomeni vsak medicinski pripomoček, ki je reagent, reagenčni izdelek, umerjevalec, kontrolni material, komplet, instrument, aparat, oprema ali sistem in se uporablja sam ali v kombinaciji, proizvajalec pa ga je namenil za uporabo in vitro za preiskavo vzorcev, vključno z darovano krvjo in tkivi, ki izhajajo iz človeškega telesa, samo ali v glavnem za zagotavljanje informacij:
concerning a physiological or pathological state, or
v zvezi s fiziološkim ali patološkim stanjem ali
concerning a congenital abnormality, or
v zvezi s prirojeno nepravilnostjo ali
to determine the safety and compatibility with potential recipients, or
za določitev varnosti in kompatibilnosti s možnimi prejemniki ali
to monitor therapeutic measures.
za spremljanje terapevtskih ukrepov.
Specimen receptacles are considered to be in vitro diagnostic medical devices.
Posode za vzorce veljajo za in vitro diagnostične medicinske pripomočke.
‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
„Posode za vzorce“ so tisti pripomočki, vakuumski ali ne, ki jih je proizvajalec namenil predvsem za to, da vsebujejo in hranijo vzorce, ki izhajajo iz človeškega telesa za namene in vitro diagnostične preiskave.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination [13];
Izdelki za splošno laboratorijsko uporabo niso in vitro diagnostični medicinski pripomočki, razen če jih je, glede na njihove značilnosti, proizvajalec posebej namenil za uporabo pri in vitro diagnostični preiskavi [13];
‘traceability’ means the ability to trace the history, application or location of that which is under consideration;
„sledljivost“ pomeni zmožnost slediti zgodovini, uporabi ali lokaciji obravnavanega elementa;
‘unique device identification — UDI’ means a series of numeric or alphanumeric characters that is created through an internationally accepted device identification and coding standard and allows the unambiguous identification of specific medical devices on the market.
„enotna identifikacija pripomočka – EIP“ pomeni zaporedje števk ali alfanumeričnih znakov, ustvarjenih z mednarodno sprejetim standardom identifikacije in kodiranja pripomočka ter omogoča nedvoumno identifikacijo posameznih medicinskih pripomočkov na trgu.
The UDI comprises the device identifier and production identifier;
EIP je sestavljena iz identifikatorja pripomočka in identifikatorja proizvodnje;
‘device identifier’ means a unique numeric or alphanumeric code specific to a manufacturer and a device model;
„identifikator pripomočka“ pomeni edinstveno številčno ali alfanumerično kodo, značilno za proizvajalca in model pripomočka;
‘production identifier’ means a unique numeric or alphanumeric code that identifies data related to the unit of device production;
„identifikator proizvodnje“ pomeni edinstveno številčno ali alfanumerično kodo, ki identificira podatke, povezane s proizvodno enoto pripomočka;
‘UDI carrier’ means the way in which the unique device identification is conveyed by means of the Automatic Identification and Data Capture [14] (AIDC) and, if applicable, its human readable interpretation (HRI);
„zapis EIP“ pomeni način, kako je enotna identifikacija pripomočka izražena s pomočjo samodejne identifikacije in zajemanja podatkov (Automatic Identification and Data Capture – AIDC [14]) in, če je primerno, njena berljiva razlaga (human readable interpretation – HRI);
‘UDI electronic system’ means a central repository/database storing device identifier codes and related/associated identifying information of specific devices placed on the Union market;
„elektronski sistem EIP“ pomeni centralno zbirko podatkov oz. podatkovno bazo, v kateri so shranjene kode identifikatorja pripomočka in s tem povezani identifikacijski podatki o specifičnih pripomočkih, danih na trg v Uniji;
‘human readable interpretation’ means a legible format of the data characters encoded in the AIDC symbol;
„berljiva razlaga“ pomeni čitljivo obliko podatkovnih znakov, zakodiranih v simbolu AIDC;
‘direct part mark’ means any technology which can be used to fix a symbol on the surface of an item (e.g. producing two different surface conditions by laser etching, moulding, peening or other technologies like ink jet printing or flexography);
„neposredna oznaka dela“ pomeni kakršno koli tehnologijo, ki se lahko uporablja za namestitev znaka na površino predmeta (npr. s povzročitvijo dveh različnih površin z laserskim vrezovanjem, ulivanjem, klesanjem ali z drugimi tehnologijami, kot sta tisk z brizgalnim tiskalnikom ali fleksotisk);
‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party [15];
„proizvajalec“ pomeni fizično ali pravno osebo, odgovorno za načrtovanje, izdelavo, pakiranje in označevanje pripomočka, preden je ta dan na trg pod njegovim lastnim imenom, ne glede na to, ali te postopke opravlja ta oseba sama ali pa v njenem imenu tretja oseba [15];
‘authorised representative’ means any natural or legal person established within the Union who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under the relevant Community legislation [16];
„pooblaščeni zastopnik“ pomeni vsako fizično ali pravno osebo s sedežem v Uniji, ki jo izrecno določi proizvajalec in deluje namesto njega ter na katero se lahko obračajo organi in telesa v Skupnosti v zvezi z obveznostmi proizvajalca po ustrezni zakonodaji Skupnosti [16];
‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market [17];
„uvoznik“ pomeni vsako fizično ali pravno osebo s sedežem v Uniji, ki da pripomoček iz tretje države na trg Unije [17];
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market [18];
„distributer“ pomeni vsako fizično ali pravno osebo v dobavni verigi, ki ni proizvajalec ali uvoznik in ki da pripomoček na trg [18];
‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor [19];
„gospodarski subjekti“ pomenijo proizvajalca, pooblaščenega zastopnika, uvoznika in distributerja [19];
‘health institution’ means an organisation whose primary purpose is the care or treatment of patients and/or the promotion of public health;
„zdravstvena ustanova“ pomeni organizacijo, katere glavni namen je nega ali zdravljenje pacientov in/ali promocija javnega zdravja;
‘user’ means the person, either professional or lay, who uses a device.
„uporabnik“ pomeni osebo, strokovno ali nestrokovno, ki uporablja pripomoček.
RISK BASED APPROACH
PRISTOP, KI TEMELJI NA OCENI TVEGANJA
Should Member States intend to establish a UDI system they should follow a risk based approach in accordance with the classification of the device.
Če države članice nameravajo vzpostaviti sistem EIP, bi morale slediti pristopu, ki temelji na oceni tveganja, v skladu s klasifikacijo pripomočka.
The UDI system should be implemented gradually, starting from highest risk class devices which should be the first to respect the condition to bear the UDI.
Sistem EIP bi bilo treba uvajati postopoma, najprej za pripomočke v najvišjem razredu tveganja, ki bi prvi morali upoštevati pogoj opremljenosti z EIP.
UDI type
Vrste EIP
The UDI should comprise two parts, a device identifier and a production identifier.
EIP bi morala biti sestavljena iz dveh delov, in sicer iz identifikatorja pripomočka in identifikatorja proizvodnje.
The device identifier should contain static information [20] specific to a manufacturer and a device model and is also used as the ‘access key’ to information stored in a UDI database.
Identifikator pripomočka bi moral vsebovati statične informacije [20], značilne za proizvajalca in model pripomočka, ki se uporabljajo tudi kot „ključ za dostop“ do podatkov, shranjenih v podatkovni bazi EIP.
The production identifier should contain dynamic information [21] identifying data related to the unit of device production and determine the level of traceability to be achieved.
Identifikator proizvodnje bi moral vsebovati dinamične informacije [21] za identifikacijo podatkov v zvezi z enoto proizvodnje pripomočka in določiti stopnjo sledljivosti, ki jo je treba doseči.
UDI should appear in both human readable format (human readable version composed of a series of numeric or alphanumeric characters) and in a format that can be read by an AIDC technology and conveyed via a carrier.
EIP bi morala biti navedena v berljivi obliki (berljiva verzija, ki jo sestavlja zaporedje številk ali alfanumeričnih znakov) in v obliki, ki jo je mogoče prebrati s tehnologijo AIDC in prenesti v obliki zapisa.
If there are significant constraints limiting the use of both AIDC and HRI on the label, the AIDC format should be favoured.
Če obstajajo ovire, ki omejujejo uporabo tako AIDC kot HRI na oznaki, bi morala imeti prednost oblika AIDC.
However, certain environments or use situations, such as home care, may warrant the use of HRI over AIDC.
Vendar je lahko v nekaterih okoljih ali okoliščinah uporabe, kot je oskrba na domu, upravičena uporaba HRI namesto AIDC.
Member States should monitor that differentiation between the different classes of devices is based exclusively on the type of production identifier (dynamic information) in accordance with paragraph 31.
Države članice bi morale spremljati, da razlikovanje med različnimi razredi pripomočkov temelji izključno na vrsti identifikatorja proizvodnje (dinamične informacije) v skladu z odstavkom 31.
As a general rule, the information provided by the production identifier (dynamic information) should vary according to the different risk classes as follows [22]:
Praviloma bi se informacije, ki jih podaja identifikator proizvodnje (dinamične informacije), morale razlikovati glede na različne razrede tveganja [22]:
expiration date and/or manufacturing date for class I,
rok uporabe in/ali datum izdelave za razred I,
lot/batch number for class IIa,
lot/številka serije za razred IIa,
lot/batch number for class IIb,
lot/številka serije za razred IIb,
lot/batch number or serial number [23] for class III.
lot/številka serije ali serijska številka [23] za razred III.
Where appropriate, manufacturers may choose a production identifier (dynamic information) applicable to a higher class than the device in question.
Kadar je to primerno, lahko proizvajalci izberejo identifikator proizvodnje (dinamične informacije), ki velja za višji razred od razreda zadevnega pripomočka.
UDI application
Uporaba EIP
As a general rule, UDI should be applied to every packaging level for all classes of devices [24].
Praviloma bi bilo EIP treba uporabiti na vsaki stopnji pakiranja za vse razrede pripomočkov [24].
UDI carrier (AIDC and HRI representation of the UDI) should be on the label of the device, its package, or on the device itself (direct part mark), and on all higher levels of packaging [25].
Zapis EIP (predstavitev AIDC in HRI) bi moral biti na oznaki pripomočka, na njegovi embalaži ali na samem pripomočku (neposredna oznaka dela) in na vseh višjih stopnjah pakiranja [25].
CONDITIONS TO BE FULFILLED BY ECONOMIC OPERATORS, HEALTH INSTITUTIONS AND PROFESSIONAL USERS
POGOJI, KI JIH MORAJO IZPOLNJEVATI GOSPODARSKI SUBJEKTI, ZDRAVSTVENE USTANOVE IN POKLICNI UPORABNIKI
In order to achieve the objectives of the UDI system, while developing their own national UDI mechanisms, the economic operators and health institutions should store through the distribution chain information related to both the device identifier (static information) and the production identifier (dynamic information).
Za doseganje ciljev sistema EIP bi morali gospodarski subjekti in zdravstvene ustanove hkrati z razvojem svojih nacionalnih mehanizmov EIP prek distribucijske verige hraniti informacije v zvezi z identifikatorjem pripomočka (statične informacije) in identifikatorjem proizvodnje (dinamične informacije).
Health institutions and, where feasible, professional users should use this information in their reporting of incidents.
Zdravstvene ustanove in, v kolikor je to izvedljivo, poklicni uporabniki bi morali te informacije uporabiti pri poročanju o zapletih.
This will, in particular, allow a more efficient action in case of recall or withdrawal of products.
To bo zlasti omogočilo učinkovitejše ukrepanje v primeru odpoklica ali umika proizvodov.
Information related to the device identifier (static information) should be collected into the national UDI databases.
Informacije o identifikatorju pripomočka (statične informacije) bi bilo treba zbirati v nacionalnih podatkovnih zbirkah EIP.
Once the future European databank on medical devices (Eudamed) is established, information related to device identifier (static information) will be centralised at European level via a European UDI electronic system which will be part of the future Eudamed.
Ko bo vzpostavljena prihodnja evropska banka podatkov za medicinske pripomočke (EUDAMED), se bodo informacije o identifikatorju pripomočka (statične informacije) zbirale na enem mestu na evropski ravni prek evropskega elektronskega sistema EIP, ki bo vključen v prihodnji EUDAMED.
As regards information related to production identifier (dynamic information), it should not be sent to the national UDI databases and will not be included in the European UDI electronic system.
Informacije o identifikatorju proizvodnje (dinamične informacije) ne bodo vključene v evropski elektronski sistem EIP in jih ne bi smeli pošiljati v nacionalne podatkovne zbirke EIP.
For the purpose of this Recommendation economic operators, health institutions and professional users should align with the following conditions.
Za namene tega priporočila bi gospodarski subjekti, zdravstvene ustanove in poklicni uporabniki morali ravnati v skladu z naslednjimi pogoji.
First, manufacturers should appropriately allocate a UDI (static and dynamic parts) to the medical devices they manufacture.
Proizvajalci bi morali ustrezno dodeliti EIP (statični in dinamični del) medicinskim pripomočkom, ki jih izdelujejo.
Second, they should provide the required data elements (see Annex) to be included in the UDI database.
Zagotoviti bi morali zahtevane podatkovne elemente (glej Prilogo), ki jih je treba vključiti v podatkovno zbirko EIP.
Third, they should modify the labelling of their products in order to print the UDI code as far as practicable on the label of the device, its package, or on the device itself (direct part mark), and on all higher levels of packaging, as referred to in paragraph 34.
Spremeniti bi morali označevanje svojih proizvodov, tako da bi natisnili kodo EIP, v kolikor je to izvedljivo, na oznako pripomočka, njegovo embalažo ali na sam pripomoček (neposredna oznaka dela) in na vse višje stopnje pakiranja, kot je navedeno v odstavku 34.
Fourth, they should keep an electronic record of both device identifier (static information) and production identifier (dynamic information).
Voditi bi morali elektronsko evidenco o identifikatorju pripomočka (statične informacije) in identifikatorju proizvodnje (dinamične informacije).
Lastly, they should keep an electronic record of the economic operator, health institution or professional users to whom they have supplied each specific product.
Nazadnje bi morali voditi elektronsko evidenco o gospodarskem subjektu, zdravstveni ustanovi ali poklicnem uporabniku, kateremu so dobavili vsak posamezni proizvod.
First, importers should verify that the manufacturer has appropriately allocated a UDI (static and dynamic parts) to the product before they put it on the Union market.
Uvozniki bi morali preveriti, ali je proizvajalec ustrezno dodelil EIP (statični in dinamični del) proizvodu, preden ga dajo na trg Unije.
Where an importer considers or has reason to believe that this condition has not been fulfilled, he should not place the device on the Union market until it is brought into conformity.
Če uvoznik meni ali upravičeno domneva, da ta pogoj ni izpolnjen, pripomočka ne bi smel dati na trg Unije, dokler ta ni usklajen.
Second, importers should not remove or modify the UDI, otherwise traceability will be impossible.
Uvozniki ne bi smeli odstraniti ali spreminjati EIP, sicer sledljivost ne bo mogoča.
Third, they should ascertain whether the device has already been registered in the UDI database of the Member State where the device has been placed on the Union market.
Preveriti bi morali, ali je pripomoček že registriran v podatkovni zbirki EIP države članice, v kateri je bil pripomoček dan na trg Unije.
If the device has already been registered, importers should verify that the device identifier (static information) on the product corresponds to that in the UDI database.
Če je bil pripomoček že registriran, bi morali uvozniki preveriti, ali identifikator pripomočka (statične informacije) na proizvodu ustreza tistemu v podatkovni zbirki EIP.
If the device has not yet been registered, the importers should align with the conditions concerning the registration of the information related to the device identifier (static information).
Če pripomoček še ni registriran, bi morali uvozniki ravnati v skladu s pogoji za registracijo informacij v zvezi z identifikatorjem pripomočka (statične informacije).
Fifth, they should keep an electronic record of the economic operator who has supplied them with a device.
Voditi bi morali elektronsko evidenco o gospodarskem subjektu, ki jim je pripomoček dobavil.
Lastly, they should keep electronic record of the economic operator, health institution or professional users to whom they have supplied the device.
Nazadnje bi morali voditi tudi elektronsko evidenco o gospodarskem subjektu, zdravstveni ustanovi ali poklicnih uporabnikih, katerim so pripomoček dobavili.
Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he should designate a single authorised representative in the Union.
Če proizvajalec, ki daje pripomoček na trg pod lastnim imenom, v državi članici nima registrirane poslovne enote, bi moral imenovati enega pooblaščenega zastopnika v Uniji.
The designation must be effective at least for all devices of the same model.
To imenovanje mora veljati vsaj za vse pripomočke istega modela.
The authorised representatives should have access, on request, to the record of both device identifier (static information) and production identifier (dynamic information) related to the product(s) for which he is appointed.
Pooblaščeni zastopniki bi morali na zahtevo imeti dostop do evidenc o identifikatorju pripomočka (statične informacije) in identifikatorju proizvodnje (dinamične informacije) za proizvode, za katere so pooblaščeni.
First, before making a device available on the market distributors should verify that the manufacturer and, where applicable, the importer has appropriately allocated a UDI (static and dynamic parts) to the product.
Preden omogočijo dostopnost pripomočka na trgu, bi distributerji morali preveriti, ali je proizvajalec in, kjer je to primerno, uvoznik proizvodu pravilno dodelil EIP (statični in dinamični del).
Where a distributor considers or has reason to believe that this condition has not been fulfilled, he should not make the device available on the Union market until it is brought into conformity.
Če distributer meni ali upravičeno domneva, da ta pogoj ni izpolnjen, ne bi smel omogočiti dostopnosti pripomočka na trgu Unije, dokler ta ni usklajen.
Second, distributors should not remove or modify the UDI, otherwise traceability will be impossible.
Distributerji ne bi smeli odstraniti ali spreminjati EIP, sicer sledljivost ne bo mogoča.
Third, they should keep an electronic record of both device identifier (static information) and production identifier (dynamic information).
Voditi bi morali elektronsko evidenco o identifikatorju pripomočka (statične informacije) in identifikatorju proizvodnje (dinamične informacije).
Fourth, they should keep an electronic record of the economic operator who has supplied them with a device.
Voditi bi morali elektronsko evidenco o gospodarskem subjektu, ki jim je pripomoček dobavil.
Lastly, they should keep an electronic record of the economic operator, health institution or professional users to whom they have supplied a device.
Nazadnje bi morali voditi elektronsko evidenco o gospodarskem subjektu, zdravstveni ustanovi ali poklicnih uporabnikih, katerim so pripomoček dobavili.
Health institutions
Zdravstvene ustanove
First, health institutions should keep an electronic record of both device identifier (static information) and production identifier (dynamic information) of medical devices entering these organisations.
Zdravstvene ustanove bi morale voditi elektronsko evidenco o identifikatorju pripomočka (statične informacije) in identifikatorju proizvodnje (dinamične informacije) za medicinske pripomočke, ki prihajajo v te organizacije.