natgillin/translations-raw huggingface dataset:
In performing its duties under the quality assurance and verification conformity assessment modules for all other classes of devices, it is essential and necessary for a notified body, in order to be assured of the compliance of the manufacturer with Directive 93/42/EEC, to review the design documentation for the medical device.
Pri izvajanju nalog v skladu z moduli za zagotavljanje kakovosti ter ocenjevanje skladnosti za vse druge razrede pripomočkov je bistveno in potrebno, da priglašeni organ pregleda projektno dokumentacijo medicinskega pripomočka, zato da se zagotovi skladnost proizvajalca z Direktivo 93/42/EGS.
The depth and extent of this review should be commensurate with the classification of the device, the novelty of the intended treatment, the degree of intervention, the novelty of the technology or construction materials, and the complexity of the design and/or technology.
Intenzivnost in obseg tega pregleda morata biti sorazmerna s klasifikacijo pripomočka, novostjo nameravanega zdravljenja, stopnjo posega, novostjo tehnologije ali sestavnih snovi, ter zahtevnostjo načrtovanja in/ali tehnologije.
This review can be achieved by taking a representative example of design documentation of one or more type(s) of devices from those being manufactured.
Ta pregled se lahko izvaja na reprezentativnem vzorcu projektne dokumentacije za eno ali več vrst pripomočkov, ki se proizvajajo.
Further review(s), and in particular the assessment of changes to the design that could affect conformity with the essential requirements, should be part of the surveillance activities of the notified body.
Nadaljnji pregled/pregledi in zlasti ocenjevanje sprememb pri načrtovanju, ki bi lahko vplivale na skladnost z bistvenimi zahtevami, bi morali biti del dejavnosti nadzora, ki ga opravlja priglašeni organ.
It is necessary to remove the incoherence in the classification rules as a result of which invasive devices with respect to body orifices intended for connection to an active Class I medical device were not classified.
Odpraviti je treba neskladja pri klasifikacijskih pravilih, ki so imela za posledico, da invazivni pripomočki, ki se uporabljajo prek telesnih odprtin in so namenjeni priključevanju na aktivne medicinske pripomočke iz razreda I, niso bili klasificirani.
The measures necessary for the implementation of Directive 90/385/EEC and Directive 93/42/EEC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission.
Ukrepe, potrebne za izvajanje Direktive 90/385/EGS in Direktive 93/42/EGS, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil.
In particular, power should be conferred on the Commission to adapt classification rules for medical devices, to adapt the means by which the information needed to use medical devices safely and properly may be set out, to determine conditions for making certain information publicly available, to adapt the provisions on clinical investigations set out in certain Annexes, to adopt particular requirements for placing certain medical devices on the market or putting them into service, and to take decisions to withdraw such devices from the market for reasons of protection of health or safety.
Komisiji bi morala biti zlasti podeljena pooblastila za prilagoditev klasifikacijskih pravil za medicinske pripomočke, prilagoditev sredstev, s katerimi je mogoče širiti informacije, potrebne za varno in pravilno uporabo medicinskih pripomočkov, določitev pogojev za dostopnost določenih podatkov, prilagoditev določb o kliničnih preiskavah, določenih v določenih prilogah, sprejetje posebnih zahtev za dajanje določenih medicinskih pripomočkov na trg ali za začetek njihove uporabe in odločanje o umiku takšnih pripomočkov iz prometa zaradi varstva zdravja ali varnosti.
Since those measures are of general scope and are designed to amend or supplement Directive 90/385/EEC and Directive 93/42/EEC by the modification or addition of non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker gre za ukrepe splošnega obsega in so namenjeni spreminjanju ali dopolnjevanju Direktive 90/385/EGS in Direktive 93/42/EGS s prilagoditvijo ali dodajanjem nebistvenih določb, se jih mora sprejeti v skladu z regulativnim postopkom s pregledom, predvidenim v členu 5a Sklepa 1999/468/ES.
When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for taking decisions on withdrawal of certain medical devices from the market and for the adoption of particular requirements for placing such devices on the market or putting them into service for reasons of protection of health or safety.
V nujnih primerih, ko ni mogoče upoštevati običajnih rokov za regulativni postopek s pregledom, bi bilo treba Komisiji omogočiti uporabo nujnega postopka, predvidenega v členu 5a(6) Sklepa 1999/468/ES za odločanje o umiku določenih medicinskih pripomočkov iz prometa in za sprejetje posebnih zahtev za dajanje takšnih pripomočkov na trg ali za začetek njihove uporabe zaradi varstva zdravja ali varnosti.
The Commission should give a mandate to CEN and/or Cenelec to specify technical requirements and a suitable specific label for phthalate-containing devices within 12 months after entry into force of this Directive.
Komisija bi morala v 12 mesecih po začetku veljavnosti te direktive podeliti mandat organizaciji CEN in/ali CENELEC za določitev tehničnih zahtev in primerne lastne oznake za pripomočke, ki vsebujejo ftalate.
Many Member States have established recommendations with the aim of reducing or limiting the use of medical devices containing critical phthalates on children, pregnant and nursing women and other patients at risk.
Mnoge države članice so oblikovale priporočila z namenom zmanjšanja ali omejitve uporabe medicinskih pripomočkov, ki vsebujejo kritične ftalate, za otroke, nosečnice, doječe matere ter druge ogrožene bolnike.
To enable medical professionals to avoid such risks, devices which possibly release phthalates to the body of the patient should be labelled accordingly.
Da bi se zdravstveni delavci lahko izognili takšnim tveganjem, bi morali biti pripomočki, pri katerih obstaja možnost sproščanja ftalatov v telo bolnika, ustrezno označeni.
In accordance with the essential requirements on the design and manufacture of medical devices, manufacturers should avoid the use of substances that may possibly compromise the health of patients, in particular of substances which are carcinogenic, mutagenic or toxic to reproduction, and should, as appropriate, strive to develop alternative substances or products with a lower risk potential.
V skladu s temeljnimi zahtevami za načrtovanje in proizvodnjo medicinskih pripomočkov bi se morali proizvajalci izogibati uporabi snovi, ki bi lahko ogrožale zdravje bolnikov, zlasti snovi, ki so karcinogene, mutagene ali škodljive za razmnoževanje, in bi si morali, kot je to primerno, prizadevati za razvoj alternativnih snovi ali proizvodov z nižjim potencialnim tveganjem.
It should be clarified that alongside Directives 90/385/EEC and 93/42/EEC, in vitro diagnostic medical devices, which are the subject of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, should also be excluded from the scope of Directive 98/8/EC.
Pojasniti bi bilo treba, da je treba poleg direktiv 90/385/EGS in 93/42/EGS s področja uporabe Direktive 98/8/ES izključiti tudi in vitro diagnostične medicinske pripomočke, ki so predmet Direktive 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih.
In accordance with point 34 of the Interinstitutional agreement on better law-making, Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
V skladu s točko 34 Medinstitucionalnega sporazuma o boljši pripravi zakonodaje se države članice spodbuja, da za svoje potrebe in v interesu Skupnosti izdelajo in objavijo lastne tabele, ki naj kolikor nazorno je to mogoče prikažejo korelacijo med to direktivo in ukrepi za prenos v nacionalno pravo.
Directives 90/385/EEC, 93/42/EEC and 98/8/EC should therefore be amended accordingly,
Zato bi bilo treba ustrezno spremeniti direktive 90/385/EGS, 93/42/EGS in 98/8/ES –
Directive 90/385/EEC is hereby amended as follows:
Direktiva 90/385/EGS se spremeni, kakor sledi:
paragraph 2 shall be amended as follows:
odstavek 2 se spremeni:
point (a) shall be replaced by the following:
točka (a) se nadomesti z:
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, 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, skupaj z dodatki, 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, prevention, monitoring, treatment or alleviation of disease,
diagnostike, preventive, spremljanja, zdravljenja ali lajšanja bolezni,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
diagnostike, spremljanja, zdravljenja, lajšanja poškodb ali okvar ali nadomestila za poškodbe in okvare,
investigation, replacement or modification of the anatomy or of a physiological process,
preiskovanja, nadomeščanja ali spreminjanja anatomije ali fiziološkega procesa,
control of conception,
nadzor 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;’
in katerega glavno načrtovano delovanje v človeškem telesu ali na človeško telo se ne doseže na farmakološki, imunološki ali metabolični način, ampak se mu lahko s temi načini pri njegovem delovanju pomaga;“;
points (d), (e) and (f) shall be replaced by the following:
točke (d), (e) in (f) se nadomestijo z:
“custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
‚uporabniku prilagojen pripomoček‘ pomeni vsak pripomoček, posebej izdelan v skladu s pisnim navodilom ustrezno usposobljenega zdravnika, v katerem so, na zdravnikovo odgovornost, navedene posebne projektne značilnosti, in ki je namenjen samo uporabi določenega pacienta.
Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;
Pripomočki, izdelani v množični proizvodnji, ki jih je treba prilagoditi, da ustrezajo posebnim zahtevam zdravnika ali katerega koli drugega strokovno usposobljenega uporabnika, se ne štejejo za uporabniku prilagojene pripomočke.
“device intended for clinical investigation” means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.
‚kliničnim preiskavam namenjen pripomoček‘ pomeni vsak pripomoček, ki je namenjen za uporabo s strani ustrezno usposobljenega zdravnika pri opravljanju kliničnih preiskav iz oddelka 2.1 Priloge 7 v ustreznem humanem kliničnem okolju.
For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
Za namen opravljanja kliničnih preiskav je vsaka druga oseba, ki je na podlagi poklicnih kvalifikacij pooblaščena za opravljanje takšnih preiskav, sprejeta kot enakovredna ustrezno usposobljenemu zdravniku;
“intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;’
‚predvideni namen‘ pomeni uporabo, za katero je namenjen pripomoček v skladu s podatki, ki jih predloži proizvajalec na nalepki, v navodilih in/ali v promocijskih gradivih;“;
“authorised representative” means any natural or legal person established in the Community 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 this Directive;
‚pooblaščeni zastopnik‘ pomeni vsako fizično ali pravno osebo s sedežem v Skupnosti, za katero je proizvajalec določil, da deluje in da jo lahko organi Skupnosti, namesto proizvajalca, prosijo za pomoč glede obveznosti proizvajalca iz te direktive;
“clinical data” means the safety and/or performance information that is generated from the use of a device.
‚klinični podatki‘ pomenijo varnostne informacije in/ali informacije o zmogljivosti, pridobljene z uporabo pripomočka.
Clinical data are sourced from:
Klinični podatki izvirajo iz:
clinical investigation(s) of the device concerned, or
klinične(-ih) preiskave(-) zadevnega pripomočka, ali
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or
klinične(-ih) preiskave(-) ali drugih raziskav podobnih pripomočkov, objavljenih v znanstveni literaturi, za katere je mogoče dokazati enakovrednost z zadevnim pripomočkom, ali
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.’;
objavljenih in/ali neobjavljenih poročil o drugih kliničnih izkušnjah z zadevnim pripomočkom ali podobnim pripomočkom, za katerega je mogoče dokazati enakovrednost z zadevnim pripomočkom.“;
Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.
Če je aktivni medicinski pripomoček za vsaditev namenjen aplikaciji snovi, ki je opredeljena kot zdravilo v smislu člena 1 Direktive 2001/83/ES, ta pripomoček ureja ta direktiva, brez poseganja v določbe Direktive 2001/83/ES glede zdravil.
paragraph 4 shall be replaced by the following:
odstavek 4 se nadomesti z:
Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.’;
Če aktivni medicinski pripomoček za vsaditev kot svoj sestavni del vsebuje snov, ki v primeru, da se uporablja ločeno, velja za zdravilo v smislu člena 1 Direktive 2001/83/ES in ki na človeško telo deluje z učinkom, ki je dopolnilen učinku pripomočka, se ta pripomoček oceni in odobri v skladu s to direktivo.“;
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device shall be assessed and authorised in accordance with this Directive.’;
Če pripomoček kot svoj sestavni del vsebuje snov, ki lahko velja, če se uporablja ločeno, za sestavino zdravila ali zdravilo, pridobljeno iz človeške krvi ali človeške plazme v smislu člena 1 Direktive 2001/83/ES, in ki ima verjetno ob tem medicinskem pripomočku na telo dopolnilni učinek, v nadaljnjem besedilu, ‚derivat človeške krvi‘, se ta pripomoček oceni in odobri v skladu s to direktivo.“;
This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC.
Ta direktiva je posebna direktiva v smislu člena 1(4) Direktive 2004/108/ES.
medicinal products covered by Directive 2001/83/EC.
zdravila, ki jih ureja Direktiva 2001/83/ES.
In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
Pri odločanju, ali izdelek ureja navedena direktiva ali ta direktiva, je treba upoštevati zlasti glavni način delovanja izdelka;
human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;
človeško kri, izdelke iz človeške krvi, človeško plazmo ali krvne celice človeškega izvora ali pripomočke, ki ob dajanju na trg vsebujejo take krvne izdelke, plazmo ali celice, z izjemo pripomočkov iz odstavka 4a;
transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
organe za presaditev oziroma tkiva ali celice človeškega izvora ali za izdelke, ki vsebujejo tkiva ali celice človeškega izvora ali so iz njih pridobljeni, razen za pripomočke iz odstavka 4a;
transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.’;
organe za presaditev ali tkiva ali celice živalskega izvora, razen če je pripomoček izdelan z uporabo živalskega tkiva, ki je postalo nesposobno preživetja, ali proizvodov, ki niso sposobni preživetja, pridobljenih iz živalskega tkiva.“;
Article 2 shall be replaced by the following:
člen 2 se nadomesti z:
Member States shall take all necessary steps to ensure that the devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied, properly implanted and/or properly installed, maintained and used in accordance with their intended purposes.’;
Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da se lahko pripomočki dajo na trg in/ali v uporabo samo, če izpolnjujejo zahteve iz te direktive, kadar so primerno dobavljeni in pravilno vsajeni in/ali pravilno nameščeni, vzdrževani in uporabljeni v skladu z njihovim predvidenim namenom.“;
Article 3 shall be replaced by the following:
člen 3 se nadomesti z:
The active implantable medical devices referred to in Article 1(2)(c), (d) and (e), hereinafter referred to as “devices”, shall satisfy the essential requirements set out in Annex 1 which apply to them, account being taken of the intended purpose of the devices concerned.
Aktivni medicinski pripomočki za vsaditev, navedeni v členu 1(2)(c), (d) in (e), v nadaljnjem besedilu ‚pripomočki‘, izpolnjujejo bistvene zahteve iz Priloge 1, ki veljajo zanje, ob upoštevanju predvidenega namena zadevnih pripomočkov.
Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex 1 to this Directive.4. in Article 4, paragraphs 1, 2 and 3 shall be replaced by the following:
Če obstaja ustrezna stopnja nevarnosti, pripomočki, ki so tudi stroji v smislu člena 2(a) Direktive 2006/42/ES Evropskega parlamenta in Sveta z dne 17. maja 2006 o strojih, ustrezajo osnovnim zdravstvenim in varnostnim zahtevam iz Priloge I navedene direktive v obsegu, v katerem so te zdravstvene in varnostne zahteve bolj specifične kot osnovne zahteve iz Priloge I k tej direktivi.4. v členu 4 se odstavki 1, 2 in 3 nadomestijo z:
Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article 12, which indicates that they have been the subject of an assessment of their conformity in accordance with Article 9.
Države članice na svojem ozemlju na noben način ne ovirajo dajanja na trg ali začetka uporabe pripomočkov, ki so v skladu z določbami te direktive in nosijo oznako CE iz člena 12, ki pomeni, da je bila opravljena ocena njihove skladnosti v skladu s členom 9.
Member States shall not create any obstacles to:
Države članice ne ovirajo:
devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,
zagotavljanja pripomočkov, namenjenih kliničnim preiskavam, ustrezno usposobljenim zdravnikom ali pooblaščenim osebam v ta namen, če izpolnjujejo pogoje iz člena 10 in Priloge 6,
custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.
dajanja na trg in začetka uporabe uporabniku prilagojenih pripomočkov, če izpolnjujejo pogoje iz Priloge 6 in če jim je priložena izjava iz te priloge, ki je na voljo posameznim identificiranim bolnikom.
These devices shall not bear the CE marking.
Ti pripomočki ne nosijo oznake CE.
At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.’;
Države članice na trgovskih sejmih, razstavah, predstavitvah itd. ne ovirajo prikazovanja pripomočkov, ki niso v skladu s to direktivo, pod pogojem, da je z vidnim znakom jasno prikazano, da takšni pripomočki niso skladni in da ne morejo biti dani na trg ali se začeti uporabljati, dokler proizvajalec ali njegov pooblaščeni zastopnik ne zagotovi njihove skladnosti.“;
Article 5 shall be replaced by the following:
člen 5 se nadomesti z:
Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union; Member States shall publish the references of such national standards.
Države članice domnevajo skladnost z bistvenimi zahtevami iz člena 3 pri pripomočkih, ki so skladni z ustreznimi nacionalnimi standardi, sprejetimi na podlagi usklajenih standardov, sklicevanja na katere so bila objavljena v Uradnem listu Evropske unije. Države članice objavijo sklicevanja na te nacionalne standarde.