natgillin/translations-raw huggingface dataset:
The clinical evaluation and its outcome shall be documented.
Klinično vrednotenje in njegovi rezultati se dokumentirajo.
This documentation shall be included and/or fully referenced in the technical documentation of the device.
Ta dokumentacija se vključi in/ali v celoti navede v tehnični dokumentaciji pripomočka.
The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance.
Klinično vrednotenje in njegova dokumentacija se mora sproti posodabljati s podatki, pridobljenimi v poprodajnem nadzoru.
Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.
Če se obravnava, da poprodajno klinično spremljanje kot del načrta za poprodajni nadzor pripomočka ni potrebno, je treba to ustrezno utemeljiti in dokumentirati.
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer.
Če se obravnava, da dokazovanje skladnosti z bistvenimi zahtevami na podlagi kliničnih podatkov ni ustrezno, je treba zagotoviti ustrezno utemeljitev za vsako takšno izključitev na podlagi rezultatov obvladovanja tveganja in ob upoštevanju posebnosti interakcije med pripomočkom in telesom, predvidenega kliničnega delovanja in zahtev proizvajalca.
Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.
Ustreznost dokazovanja skladnosti z bistvenimi zahtevami z vrednotenjem delovanja, laboratorijskimi preskusi in predkliničnim vrednotenjem je treba ustrezno utemeljiti.
All data must remain confidential unless it is deemed essential that they be divulged.’
Vsi podatki morajo ostati zaupni, razen če jih je treba nujno objaviti.“;
Section 2.3.5 shall be replaced by the following:
oddelek 2.3.5 se nadomesti z:
All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.’
Vsi resni neželeni dogodki morajo biti v celoti zabeleženi in takoj posredovani vsem pristojnim organom držav članic, kjer potekajo klinične preiskave.“;
In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘duly qualified medical practitioner or authorised person’.
v oddelku 2.3.6 se besede „ustrezno usposobljenega zdravstvenega specialista“ nadomestijo z besedami „ustrezno usposobljenega zdravnika ali pooblaščene osebe“.
OJ L 180, 9.7.1997, p. 22.’;
UL L 180, 9.7.1997, str. 22.“
Regulation as last amended by Regulation (EC) No 1901/2006.’;
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1901/2006.“;
Annexes I to X to Directive 93/42/EEC shall be amended as follows:
Priloge I do X k Direktivi 93/42/EGS se spremenijo:
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
Pripomočki morajo biti načrtovani in izdelani tako, da ob uporabi pod predvidenimi pogoji in za predvideni namen ne ogrožajo kliničnega stanja ali varnosti bolnikov ali varnosti in zdravja uporabnikov ali, če je primerno, drugih oseb, pod pogojem, da vsako morebitno tveganje, povezano z njihovo uporabo, predstavlja sprejemljivo tveganje v primerjavi s koristjo za bolnika in da je združljivo z visoko ravnijo zaščite zdravja in varnosti.
This shall include:
To vključuje:
reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
največje mogoče zmanjševanje tveganja za napako pri uporabi zaradi ergonomskih značilnosti pripomočka in okolja, v katerem naj bi se pripomoček uporabljal (načrtovanje za varstvo bolnikov), in
consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).’;
upoštevanje tehničnega znanja, izkušenj, izobraževanja, usposabljanja in, če je to primerno, medicinskih in fizičnih pogojev predvidenih uporabnikov (načrtovanje za laične, strokovne, invalidne in druge uporabnike).“;
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’;
Dokazovanje skladnosti z bistvenimi zahtevami mora vključevati klinično vrednotenje v skladu s Prilogo X.“;
in Section 7.1, the following indent shall be added:
v oddelku 7.1 se doda alinea:
where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’;
če je to primerno, rezultatom biofizikalnih raziskav ali raziskav modelov, katerih ustreznost mora biti predhodno dokazana.“;
Section 7.4. shall be replaced by the following:
oddelek 7.4 se nadomesti z:
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.
Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja, če se uporablja ločeno, za zdravilo iz člena 1 Direktive 2001/83/ES, in ki ima verjetno ob tem pripomočku na telo dopolnilni učinek, je treba kakovost, varnost in uporabnost te snovi preveriti po analogiji z metodami iz Priloge I k Direktivi 2001/83/ES.
Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device.
Če pripomoček kot sestavni del vsebuje derivat človeške krvi, zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od EMEA, ki deluje zlasti prek svojega odbora, znanstveno mnenje o kakovosti in varnosti snovi, vključno z mnenjem o razmerju med klinično koristjo in tveganjem vključitve derivata človeške krvi v pripomoček.
The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.
Pristojni organ upošteva podatke o uporabnosti vključitve snovi v pripomoček, kot to določa priglašeni organ, in tako zagotovi, da spremembe nimajo negativnega vpliva na ugotovljeno razmerje med koristjo in tveganjem dodajanja snovi medicinskemu pripomočku.
When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not.
Kadar je ustrezni pristojni organ za zdravila (tj. tisti, ki sodeluje pri začetnem posvetovanju) prejel podatke o pomožni snovi, ki bi lahko vplivala na ugotovljeno razmerje med koristjo in tveganjem dodajanja snovi v medicinski pripomoček, priglašenemu organu svetuje, ali imajo ti podatki vpliv na vzpostavljeno razmerje med koristjo in tveganjem dodajanja snovi medicinskemu pripomočku.
Section 7.5 shall be replaced by the following:
oddelek 7.5 se nadomesti z:
The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device.
Pripomočki morajo biti načrtovani in izdelani tako, da je kar najbolj zmanjšana nevarnost, ki jo predstavljajo snovi, ki uhajajo iz pripomočka.
Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.
Posebno pozornost se v skladu s Prilogo I k Direktivi Sveta št. 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi nameni snovem, ki so kancerogene, mutagene ali strupene za razmnoževanje.
If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.
Če deli pripomočka (ali sam pripomoček), ki je namenjen dajanju zdravil in/ali odstranjevanju zdravil, telesnih tekočin ali drugih snovi v telo oziroma iz njega, ali če pripomočki, ki so namenjeni prenašanju ali hranjenju tovrstnih telesnih tekočin ali snovi, vsebujejo ftalate, ki so razvrščeni kot kancerogeni, mutageni ali strupeni za razmnoževanje ter sodijo v kategoriji 1 ali 2 v skladu s Prilogo I k Direktivi 67/548/EGS, mora biti na pripomočku samem in/ali na embalaži vsake enote ali po potrebi na prodajni embalaži označeno, da vsebujejo ftalate.
If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.
Če je uporaba takšnih pripomočkov predvidena tudi za zdravljenje otrok, nosečnic ali doječih mater, mora proizvajalec v tehnični dokumentaciji priložiti posebno obrazložitev za uporabo teh snovi, glede njihovega izpolnjevanja bistvenih zahtev, še posebej iz tega odstavka, v tehnični dokumentaciji in v navodilih za uporabo pa mora navesti podatke o stopnji ostanka tveganja za to skupino bolnikov in, če je primerno, podatke o ustreznih previdnostnih ukrepih.
in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’;
v oddelku 8.2 se beseda „prenosljivimi“ nadomesti z besedo „nalezljivimi“;
‘12.1a
„12.1a
For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;
Za pripomočke, ki vsebujejo programsko opremo ali ki so sami po sebi medicinska programska oprema, mora biti programska oprema potrjena v skladu s tehničnim razvojem ob upoštevanju načel razvojnega življenjskega cikla, obvladovanja tveganja, validacije in verifikacije.“;
in Section 13.1, the first paragraph shall be replaced by the following:
v oddelku 13.1 se prvi odstavek nadomesti z:
Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’;
Vsakemu pripomočku morajo biti priložene informacije, potrebne za varno in pravilno uporabo, ob upoštevanju usposobljenosti in znanja morebitnih uporabnikov, in za identifikacijo proizvajalca.“;
Section 13.3 shall be amended as follows:
oddelek 13.3 se spremeni:
the name or trade name and address of the manufacturer.
ime ali blagovno znamko ter naslov proizvajalca.
For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;’
Za pripomočke, ki so uvoženi v Skupnost, morajo za njihovo distribucijo v Skupnosti nalepka ali zunanja embalaža ali navodila za uporabo vsebovati razen tega še ime in naslov pooblaščenega zastopnika, če proizvajalec v Skupnosti nima registrirane poslovne enote;“;
point (b) shall be replaced by the following:
točka (b) se nadomesti z:
the details strictly necessary to identify the device and the contents of the packaging especially for the users;’
podatke, ki so nujno potrebni, da lahko zlasti uporabnik prepozna pripomoček in vsebino embalaže;“;
where appropriate, an indication that the device is for single use.
kjer je primerno, oznako, da je pripomoček namenjen za enkratno uporabo.
A manufacturer's indication of single use must be consistent across the Community;’
Oznaka proizvajalca o enkratni uporabi mora biti enotna v vsej Skupnosti;“;
Section 13.6 shall be amended as follows:
oddelek 13.6 se spremeni:
the following subparagraph shall be added to point (h):
k točki (h) se doda naslednji tretji odstavek:
‘If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used.
„če pripomoček nosi oznako o enkratni uporabi, informacije o njegovih ugotovljenih značilnostih in tehničnih dejavnikih, ki jih je ugotovil proizvajalec in ki bi lahko predstavljali tveganje v primeru ponovne uporabe pripomočka.
If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;’
Če v skladu z oddelkom 13.1 navodila za uporabo niso potrebna, je treba podatke uporabniku dati na voljo na njegovo zahtevo;“;
point (o) shall be replaced by the following:
točka (o) se nadomesti z:
medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;’
zdravilne učinkovine ali derivate človeške krvi, vključene v pripomoček kot njegov sestavni del v skladu z oddelkom 7.4;“;
Section 14 shall be deleted.
oddelek 14 se črta;
Section 2 shall be replaced by the following:
oddelek 2 se nadomesti z:
The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.
ES-izjava o skladnosti je postopek, v katerem proizvajalec, ki izpolnjuje obveznosti iz oddelka 1, zagotovi in izjavi, da zadevni proizvodi izpolnjujejo določbe direktive, ki se uporabljajo zanje.
The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity.
Proizvajalec mora pritrditi oznako CE v skladu s členom 17 in izdati pisno izjavo o skladnosti.
This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;
V izjavi morajo biti navedeni in jasno opredeljeni eden ali več proizvedenih medicinskih pripomočkov, in sicer z imenom proizvoda, njegovo kodo ali drugo nedvoumno oznako. Proizvajalec mora izjavo hraniti.“;
in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:
v drugem odstavku oddelka 3.1 se uvodni del sedme alinee nadomesti z:
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action.
jamstvo proizvajalca, da bo uporabljal in ohranjal ažurne sistematične postopke za pregledovanje izkušenj, pridobljenih iz pripomočkov v fazi po proizvodnji, vključno z določbami iz Priloge X, in da bo uporabljal ustrezna sredstva za uveljavljanje vseh potrebnih korektivnih postopkov.
This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:’;
To jamstvo mora zajemati tudi obveznost proizvajalca, da obvešča pristojne organe o naslednjih dogodkih, takoj ko zanje izve:“;
the following paragraph shall be inserted after the first paragraph:
za prvim odstavkom se vstavi naslednji odstavek:
in point (b), the following indent shall be added:
v točki (b) se doda naslednja alinea:
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
če načrtovanje, izdelavo in/ali končen nadzor ter preskušanje izdelkov ali njihovih elementov izvaja tretja oseba, metod spremljanja učinkovitosti delovanja sistema kakovosti ter zlasti vrste in obsega nadzora tretje osebe;“;
the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:
postopkov spremljanja in preverjanja načrtovanja izdelkov, vključno z ustrezno dokumentacijo, ter zlasti:
a general description of the product, including any variants planned, and its intended use(s),
splošni opis izdelka, vključno z vsemi načrtovanimi različicami in predvideno uporabo/predvidenimi uporabami,
the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,
specifikacije načrta, vključno s standardi, ki bodo uporabljeni, in rezultati analize tveganj, ter opis rešitev, sprejetih za izpolnjevanje bistvenih zahtev, ki veljajo za izdelke, če standardi iz člena 5 niso v celoti uporabljeni,
the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,
tehnike, uporabljene za nadzor in preverjanja načrtovanja, in postopki ter sistematični ukrepi, ki bodo uporabljeni med načrtovanjem izdelkov,
if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
če bo pripomoček za svoje predvideno delovanje priključen na drug pripomoček/druge pripomočke, mora biti predložen dokaz, da izpolnjuje bistvene zahteve ob priključitvi na vsak tak pripomoček/take pripomočke z lastnostmi, ki jih določa proizvajalec,
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
izjavo o tem, ali pripomoček kot sestavni del vsebuje snov ali derivat človeške krvi iz oddelka 7.4 Priloge I, ter podatke preskusov, ki so bili opravljeni v zvezi s tem in ki so potrebni za oceno varnosti, kakovosti in uporabnosti navedene snovi ali derivata človeške krvi, ob upoštevanju predvidenega namena pripomočka,
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC,the solutions adopted as referred to in Annex I, Chapter I, Section 2,
izjavo o tem, ali je pripomoček izdelan z uporabo tkiv živalskega izvora iz Direktive Komisije 2003/32/ES,rešitve, sprejete v skladu z oddelkom 2 poglavja I Priloge I,
the clinical evaluation referred to in Annex X,
klinično vrednotenje iz Priloge X,
the draft label and, where appropriate, instructions for use.
osnutek nalepke in, če je primerno, navodila za uporabo.
the second paragraph of Section 3.3 shall be replaced by the following:
drugi odstavek oddelka 3.3 se nadomesti z:
‘The assessment team must include at least one member with past experience of assessments of the technology concerned.
„Ocenjevalna ekipa mora vključevati vsaj enega člana z izkušnjami pri vrednotenju zadevne tehnologije.
The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;
Postopek ocenjevanja mora vključevati ocenjevanje dokumentacije načrtovanja zadevnega izdelka/zadevnih izdelkov na reprezentativni podlagi, obisk inšpekcije v prostorih proizvajalca ter, v utemeljenih primerih, v prostorih proizvajalčevih dobaviteljev in/ali podizvajalcev, da se preveri proizvodni postopek.“;
in Section 4.3, the second and third paragraphs shall be replaced by the following:
v oddelku 4.3 se drugi in tretji odstavek nadomestita z:
‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision.
„V primeru pripomočkov iz drugega odstavka oddelka 7.4 Priloge I se priglašeni organ v zvezi z vidiki iz tega oddelka pred odločitvijo posvetuje z enim od pristojnih organov, ki jih določijo države članice v skladu z Direktivo 2001/83/ES ali z EMEA.
The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation.
Mnenje pristojnega nacionalnega organa ali EMEA je treba pripraviti v 210 dneh po prejemu veljavne dokumentacije.
In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device.
V primeru pripomočkov iz tretjega odstavka oddelka 7.4 Priloge I je treba znanstveno mnenje EMEA vključiti v dokumentacijo o pripomočku.
The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation.
EMEA mora mnenje oblikovati v 210 dneh po prejemu veljavne dokumentacije.
It will convey its final decision to the EMEA.
Končno odločitev predloži EMEA.
In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.’;
V primeru pripomočkov, izdelanih z uporabo tkiv živalskega izvora iz Direktive 2003/32/ES, mora priglašeni organ upoštevati postopke iz navedene direktive.“;