natgillin/translations-raw huggingface dataset:
a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;
načela delovanja pripomočka in po potrebi znanstveno dokazan način njegovega delovanja;
a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;
utemeljitev za opredelitev izdelka kot pripomočka;
a general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition.
razred tveganja pripomočka in utemeljitev pravila ali pravil, ki se uporabljajo za razvrščanje v skladu s Prilogo VIII;
Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams;
obrazložitev morebitnih novih značilnosti;
a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;
opis dodatkov za pripomoček, drugih pripomočkov in drugih izdelkov, ki niso pripomočki in so namenjeni uporabi v kombinaciji s pripomočkom;
technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.
opis ali popolni seznam različnih konfiguracij/različic pripomočka, ki naj bi bili dostopni na trgu;
Reference to previous and similar generations of the device
splošen opis ključnih funkcionalnih elementov, npr. njegovih delov/komponent (po potrebi vključno s programsko opremo), njegove formulacije, sestave, funkcionalnosti in, kadar je to ustrezno, njegove kvalitativne in kvantitativne sestave.
an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;
To po potrebi vključuje označene slikovne predstavitve (npr. diagrame, fotografije in risbe), pri čemer so jasno navedeni ključni deli/komponente, vključno z dovolj natančno obrazložitvijo za razumevanje risb in diagramov;
an overview of identified similar devices available on the Union or international markets, where such devices exist.
opis surovin, vključenih v glavne funkcionalne elemente in elemente v neposrednem stiku s človeškim telesom ali posrednem stiku s telesom, npr. med zunajtelesnim obtokom telesnih tekočin;
INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
tehnične specifikacije, na primer značilnosti, dimenzije in učinkovitost, pripomočka in katerih koli različic/konfiguracij in dodatkov, običajno zajetih v specifikacijo izdelka, ki je na voljo uporabniku, na primer v brošurah, katalogih in podobnih publikacijah.
A complete set of:
Sklicevanje na prejšnje in podobne generacije pripomočka
the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and
Pregled predhodne generacije ali generacij pripomočka, ki ga izdeluje proizvajalec, če takšni pripomočki obstajajo;
the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.
pregled opredeljenih podobnih pripomočkov, ki so dostopni na trgu Unije ali mednarodnih trgih, če takšni pripomočki obstajajo.
DESIGN AND MANUFACTURING INFORMATION
INFORMACIJE, KI JIH MORA PREDLOŽITI PROIZVAJALEC
information to allow the design stages applied to the device to be understood;
Celoten sklop:
complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing.
oznake oziroma oznak na pripomočku in njegovi embalaži, na primer embalaži ene same enote, prodajni embalaži, transportni embalaži v primeru posebnih pogojev upravljanja, in sicer v jezikih, sprejetih v državah članicah, v katerih naj bi se pripomoček prodajal, in
Data shall be fully included in the technical documentation;
navodil za uporabo v jezikih, sprejetih v državah članicah, v katerih naj bi se pripomoček prodajal.
identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.
INFORMACIJE O ZASNOVI IN IZDELAVI
The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.
Informacije za razumevanje faz zasnove, ki se uporabljajo za pripomoček;
The demonstration of conformity shall include:
popolni podatki in specifikacije, vključno s postopki izdelave in njihovim potrjevanjem, nadomestnimi snovmi, stalnim spremljanjem in preskušanjem končnega izdelka.
the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;
Podatki se v celoti vključijo v tehnično dokumentacijo;
the method or methods used to demonstrate conformity with each applicable general safety and performance requirement;
opredelitev vseh lokacij, vključno z dobavitelji in podizvajalci, kjer se izvajajo dejavnosti zasnove in izdelave.
the harmonised standards, CS or other solutions applied; and
Dokumentacija vsebuje informacije s prikazom skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I, ki se uporabljajo za pripomoček, ob upoštevanju njegovega predvidenega namena, ter vključuje utemeljitev, potrditev in preverjanje rešitev, sprejetih za izpolnitev teh zahtev.
the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements.
Prikaz skladnosti zajema:
The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.
splošne zahteve glede varnosti in učinkovitosti, ki se uporabljajo za pripomoček, in razlago, zakaj se druge ne uporabljajo;
BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
metodo oziroma metode, ki se uporabljajo za dokazovanje skladnosti z vsako ustrezno splošno zahtevo glede varnosti in učinkovitosti;
The documentation shall contain information on:
veljavne harmonizirane standarde, uporabljene skupne specifikacije ali druge rešitve in
the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and
natančno opredelitev preverjenih dokumentov z dokazili o skladnosti z vsakim harmoniziranim standardom, skupno specifikacijo ali drugo metodo, uporabljeno za dokazovanje skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti.
the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.
Informacije iz te točke vključujejo sklicevanje na mesto navajanja teh dokazov v celotni tehnični dokumentaciji in po potrebi povzetku tehnične dokumentacije.
PRODUCT VERIFICATION AND VALIDATION
ANALIZA RAZMERJA MED KORISTMI IN TVEGANJI TER OBVLADOVANJE TVEGANJ
The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.
Dokumentacija vsebuje naslednje informacije:
Pre-clinical and clinical data
analizo razmerja med koristmi in tveganji iz oddelkov 1 in 8 Priloge I ter
results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;
sprejete rešitve in rezultate obvladovanja tveganj iz oddelka 3 Priloge I.
detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:
PREVERJANJE IN POTRJEVANJE IZDELKA
the biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user;
Dokumentacija vključuje rezultate in kritične analize vseh preverjanj in validacijskih preskusov in/ali opravljenih študij za dokazovanje skladnosti pripomočka z zahtevami iz te uredbe in zlasti s splošnimi zahtevami glede varnosti in učinkovitosti.
physical, chemical and microbiological characterisation;
Predklinični in klinični podatki
electrical safety and electromagnetic compatibility;
rezultati preskusov, na primer inženiringa, laboratorijskih preskusov, preskusov simulirane uporabe in preskusov na živalih, ter ocene objavljene literature, ki se nanašajo na pripomoček, ob upoštevanju njegovega predvidenega namena, ali na zelo podobne pripomočke, v zvezi s predklinično varnostjo pripomočka in njegovo skladnostjo s specifikacijami;
software verification and validation (describing the software design and development process and evidence of the validation of the software, as used in the finished device.
podrobne informacije o zasnovi preskusov, popolnih protokolih preskusov ali študij, metodah za analizo podatkov, skupaj s povzetki podatkov in ugotovitvami preskusov, zlasti v zvezi z:
This information shall typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release.
biokompatibilnostjo pripomočka, vključno z opredelitvijo vseh materialov v neposrednem ali posrednem stiku s pacientom ali uporabnikom;
It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the information supplied by the manufacturer);
fizikalnimi, kemijskimi in mikrobiološkimi značilnostmi;
stability, including shelf life; and
električno varnostjo in elektromagnetno združljivostjo;
performance and safety.
preverjanjem in potrjevanjem programske opreme (opisovanje zasnove in razvojnega postopka programske opreme ter dokazila o potrditvi programske opreme, kot se uporablja v končnem pripomočku.
Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council [1] shall be demonstrated.Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision.
Te informacije običajno zajemajo povzetek rezultatov vseh notranjih preverjanj, potrditev in preskušanj ter preverjanj, potrditev in preskušanja v simuliranem ali dejanskem okolju uporabnika pred končno sprostitvijo.
An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service;
Prav tako obravnavajo vse različne konfiguracije strojne opreme in po potrebi operativne sisteme, opredeljene v informacijah proizvajalca);
the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;
stabilnostjo, vključno z rokom trajanja, in
the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.
učinkovitostjo in varnostjo.
Additional information required in specific cases
Kadar je to ustrezno, se dokaže skladnost z določbami Direktive 2004/10/ES Evropskega parlamenta in Sveta [1].Kadar ni izvedeno nobeno novo preskušanje, dokumentacija zajema utemeljitev navedene odločitve.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8), a statement indicating this fact.
Primer takšne utemeljitve bi lahko bil na primer, da je bil izveden preskus biokompatibilnosti na enakih materialih, kot so bili vključeni v prejšnje različice pripomočka, ki je bil zakonito dan na trg ali v uporabo;
In this case, the documentation shall identify the source of that substance and contain the data of the tests conducted to assess its safety, quality and usefulness, taking account of the intended purpose of the device.
poročilo o klinični oceni in njegove posodobitve ter načrt klinične ocene iz člena 61(12) in dela A Priloge XIV;
Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, and is covered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a device incorporates, as an integral part, tissues or cells of human origin or their derivatives that have an action ancillary to that of the device and is covered by this Regulation in accordance with the first subparagraph of Article 1(10), a statement indicating this fact.
načrt kliničnega spremljanja po dajanju na trg in poročilo o ocenjevanju kliničnega spremljanja po dajanju na trg iz dela B Priloge XIV ali utemeljitev, zakaj se klinično spremljanje po dajanju na trg ne uporablja.
In such a case, the documentation shall identify all materials of human or animal origin used and provide detailed information concerning the conformity with Sections 13.1. or 13.2., respectively, of Annex I.
Dodatne informacije, ki se zahtevajo v posebnih primerih
In the case of devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, detailed information, including test design, complete test or study protocols, methods of data analysis, and data summaries and test conclusions, regarding studies in relation to:
V izjavi je treba navesti, kadar pripomoček kot sestavni del vključuje snov, ki se ob ločeni uporabi lahko šteje za zdravilo v smislu točke 2 člena 1 Direktive 2001/83/ES, vključno z zdravilom, pridobljenim iz človeške krvi ali človeške plazme, kot je navedeno v prvem pododstavku člena 1(8).
absorption, distribution, metabolism and excretion;
V tem primeru se v dokumentaciji opredeli vir navedene snovi in navedejo podatki o opravljenih preskusih za ocenitev njene varnosti, kakovosti in uporabnosti, ob upoštevanju predvidenega namena pripomočka;
possible interactions of those substances, or of their products of metabolism in the human body, with other devices, medicinal products or other substances, considering the target population, and its associated medical conditions;
v izjavi je treba navesti, kadar je pripomoček izdelan z uporabo človeških ali živalskih tkiv ali celic ali njihovih derivatov in zanj velja ta uredba v skladu s točkama (f) in (g) člena 1(6) in kadar pripomoček kot sestavni del vsebuje človeška tkiva ali celice ali njihove derivate, ki dopolnjuje učinek pripomočka, in zanj velja ta uredba v skladu s prvim pododstavkom člena 1(10).
local tolerance; and
V takšnem primeru se v dokumentaciji opredelijo vsi uporabljeni materiali človeškega ali živalskega izvora in zagotovijo podrobne informacije o skladnosti z oddelkom 13.1. oziroma 13.2.
toxicity, including single-dose toxicity, repeat-dose toxicity, genotoxicity, carcinogenicity and reproductive and developmental toxicity, as applicable depending on the level and nature of exposure to the device.
Priloge I;
In the absence of such studies, a justification shall be provided.
v primeru pripomočkov, sestavljenih iz snovi ali kombinacij snovi, ki so namenjene vnosu v človeško telo in ki jih človeško telo absorbira ali se lokalno razpršijo po človeškem telesu, podrobne informacije, vključno glede zasnove preskusov, popolnih protokolov preskusov ali študij, metod za analizo podatkov, ter povzetke podatkov in ugotovitve preskusov iz študij, in sicer v zvezi z:
In the case of devices containing CMR or endocrine-disrupting substances referred to in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.
absorpcijo, porazdelitvijo, metabolizmom in izločanjem;
In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps.
morebitnimi interakcijami teh snovi ali njihovih produktov presnove v človeškem telesu z drugimi pripomočki, zdravili ali drugimi snovmi, ob upoštevanju ciljne populacije in z njo povezanimi zdravstvenimi stanji;
In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility.
lokalno toleranco in
The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.
toksičnostjo, vključno s toksičnostjo pri enkratnem odmerku, toksičnostjo pri večkratnih odmerkih, genotoksičnostjo in rakotvornostjo ter reproduktivno in razvojno toksičnostjo, kot je ustrezno glede na raven in naravo izpostavljenosti pripomočku.
In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.
Če takšnih študij ni, se predloži utemeljitev;
If the device is to be connected to other device(s) in order to operate as intended, a description of this combination/configuration including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer.
v primeru pripomočkov, ki vsebujejo karcinogene, mutagene ali strupene snovi ali pa endokrine motilce iz oddelka 10.4.1.
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
Priloge I, utemeljitev iz oddelka 10.4.2. navedene priloge;
ANNEX III
v primeru pripomočkov, danih na trg v sterilnem ali določenem mikrobiološkem stanju, opis okoljskih razmer za ustrezne faze izdelave.
TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
V primeru pripomočkov, danih na trg v sterilnem stanju, opis uporabljenih metod, vključno s poročili o potrditvi, glede embalaže, sterilizacije in ohranjanja sterilnosti.
The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.
Poročilo o validaciji vsebuje rezultate preskušanja vsebnosti biološkega bremena, pirogenov in po potrebi ostankov sterilizacijskih sredstev;
The post-market surveillance plan drawn up in accordance with Article 84.
v primeru pripomočkov z merilno funkcijo, danih na trg, opis uporabljenih metod, da se zagotovi natančnost, kot je določeno v specifikacijah;
The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.
če je pripomoček povezan z drugimi pripomočki, da lahko deluje tako, kot je predvideno, opis te kombinacije/konfiguracije, skupaj z dokazilom, da izpolnjuje splošne zahteve glede varnosti in učinkovitosti ob priključitvi na vsak tak pripomoček, ob upoštevanju lastnosti, ki jih opredeli proizvajalec.
The post-market surveillance plan shall address the collection and utilization of available information, in particular:
Direktiva 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi (UL L 50, 20.2.2004, str.
information concerning serious incidents, including information from PSURs, and field safety corrective actions;
44).
records referring to non-serious incidents and data on any undesirable side-effects;
PRILOGA III
information from trend reporting;
TEHNIČNA DOKUMENTACIJA O NADZORU PO DAJANJU NA TRG
relevant specialist or technical literature, databases and/or registers;
Tehnična dokumentacija o nadzoru po dajanju na trg, ki jo pripravi proizvajalec v skladu s členi 83 do 86, se predstavi na jasen, dobro strukturiran, zlahka dostopen in nedvoumen način ter vključuje zlasti elemente, opisane v tej prilogi.
information, including feedbacks and complaints, provided by users, distributors and importers; and
Načrt nadzora po dajanju na trg, sestavljen v skladu s členom 84.
publicly available information about similar medical devices.
Proizvajalec v načrtu nadzora po dajanju na trg dokaže, da izpolnjuje obveznosti iz člena 83.
The post-market surveillance plan shall cover at least:
Z načrtom nadzora po dajanju na trg se poskrbi za zbiranje in uporabo razpoložljivih informacij, zlasti:
a proactive and systematic process to collect any information referred to in point (a).
informacij o resnih zapletih, vključno z informacijami iz redno posodobljenih poročil o varnosti, in varnostnih korektivnih ukrepih,
The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
evidenc o zapletih, ki niso resni, in podatkov o morebitnih neželenih stranskih učinkih,
effective and appropriate methods and processes to assess the collected data;
informacij iz poročanja o trendih,
suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
relevantne strokovne ali tehnične literature, podatkovnih zbirk in/ali registrov,
effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
informacij, vključno z zagotavljanjem povratnih informacij in pritožb uporabnikov, distributerjev in uvoznikov, ter
methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
javno dostopnih informacij o podobnih medicinskih pripomočkih.
methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
Načrt nadzora po dajanju na trg zajema vsaj:
reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
proaktiven in sistematičen postopek zbiranja vseh informacij iz točke (a).
systematic procedures to identify and initiate appropriate measures including corrective actions;
Ta postopek omogoča pravilno opredelitev delovanja pripomočkov, pa tudi primerjavo pripomočka s podobnimi izdelki, ki so dostopni na trgu;
effective tools to trace and identify devices for which corrective actions might be necessary; and
učinkovite in ustrezne metode in postopke za oceno zbranih podatkov;
a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
ustrezne kazalnike in mejne vrednosti, na podlagi katerih je mogoče vedno znova vrednotiti analize razmerja med koristmi in tveganji ter obvladovanja tveganj iz oddelka 3 Priloge I;