natgillin/translations-raw huggingface dataset:
Prior to being placed on the market or put into service, active implantable medical devices and medical devices of class III in accordance with the classification rules set out in Annex IX to Directive 93/42/EEC, whether they originate in the European Union or are imported from third countries, are subject to the conformity assessment procedures laid down in Article 9(1) of Directive 90/385/EEC and in Article 11(1) of Directive 93/42/EEC, respectively.
Pred dajanjem na trg ali v uporabo je pri aktivnih medicinskih pripomočkih za vsaditev in medicinskih pripomočkih razreda III po klasifikacijskih pravilih iz Priloge IX k Direktivi 93/42/EGS treba opraviti postopke ocenjevanja skladnosti iz člena 9(1) Direktive 90/385/EGS oziroma člena 11(1) Direktive 93/42/EGS, ne glede na to, ali izvirajo iz Evropske unije ali so uvoženi iz tretjih držav.
Annex 1 to Directive 90/385/EEC and Annex I to Directive 93/42/EEC, respectively, set out the essential requirements that active implantable medical devices and other medical devices must meet in this regard.
Priloga 1 k Direktivi 90/385/EGS oziroma Priloga I k Direktivi 93/42/EGS določata bistvene zahteve, ki jih morajo s tem v zvezi izpolnjevati aktivni medicinski pripomočki za vsaditev in drugi medicinski pripomočki.
With regard to active implantable medical devices and other medical devices manufactured utilising tissues of animal origin it is necessary to adopt more detailed specifications in relation to the requirements set out in point 6 of Annex 1 to Directive 90/385/EEC and points 8.1 and 8.2 of Annex I to Directive 93/42/EEC.
V zvezi z aktivnimi medicinskimi pripomočki za vsaditev in drugimi medicinskimi pripomočki, izdelanimi z uporabo živalskih tkiv, je treba sprejeti podrobnejše tehnične zahteve v zvezi z zahtevami iz točke 6 Priloge 1 k Direktivi 90/385/EGS ter točk 8.1 in 8.2 Priloge I k Direktivi 93/42/EGS.
Moreover, it is appropriate to specify certain aspects relating to the risk analysis and risk management in the framework of the conformity assessment procedures referred to in Article 9 of Directive 90/385/EEC and Article 11 of Directive 93/42/EEC, respectively.
Poleg tega je primerno določiti nekatere vidike v zvezi z analizo in obvladovanjem tveganj v okviru postopkov ocenjevanja skladnosti, navedenih v členu 9 Direktive 90/385/EGS oziroma členu 11 Direktive 93/42/EGS.
Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules concerning animal by-products not intended for human consumption [4] sets out provisions on the sourcing of materials used in medical devices.
Uredba (ES) št. 1069/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o določitvi zdravstvenih pravil za živalske stranske proizvode, ki niso namenjeni prehrani ljudi [4], vsebuje določbe za izvor surovin za medicinske pripomočke.
It is appropriate to lay down additional provisions on the use of such materials as starting tissue for the manufacture of medical devices.
Primerno je določiti dodatne določbe glede uporabe takih surovin kot vhodnega tkiva za izdelavo medicinskih pripomočkov.
European and international scientific bodies, such as the European Medicines Agency [5], the European Food Safety Agency [6], the former Scientific Steering Committee [7] and the former Scientific Committee on Medicinal Products and Medical Devices [8], adopted several opinions on specified risk materials and on minimising the risk of transmitting animal spongiform encephalopathy agents which are of relevance to the safety of medical devices.
(7) Evropski in mednarodni znanstveni organi, kot so Evropska agencija za zdravila [5], Evropska agencija za varnost hrane [6], nekdanji Znanstveni usmerjevalni odbor [7] ter nekdanji Znanstveni odbor za zdravila in medicinske pripomočke [8], so sprejeli številna mnenja o snoveh s specifičnim tveganjem in kar največjem zmanjšanju tveganja prenosa povzročiteljev živalske spongiformne encefalopatije, ki so pomembna za varnost medicinskih pripomočkov.
The Member States should verify that the notified bodies designated to assess the conformity of medical devices manufactured utilising animal tissues have the necessary expertise and up-to-date knowledge to perform this task.
Države članice morajo preveriti, ali imajo priglašeni organi, ki so določeni za ocenjevanje ustreznosti medicinskih pripomočkov, izdelanih z uporabo živalskih tkiv, potrebno strokovno in najnovejše znanje za opravljanje te naloge.
The period for scrutiny granted to the competent authorities of the Member States in relation to the notified bodies’ summary evaluation report should be shorter for medical devices manufactured using starting material which is certified by the European Directorate for the Quality of Medicines than in cases where uncertified material is used.
Obdobje pregleda, odobreno pristojnim organom držav članic v zvezi s povzetkom poročila o oceni, ki ga izdajo priglašeni organi, mora biti krajše pri medicinskih pripomočkih, izdelanih iz vhodnih materialov, ki jih je certificiral Evropski direktorat za kakovost zdravil, kot v primeru uporabe necertificiranih materialov.
In both cases, there should be a possibility to shorten the standstill period.
V obeh primerih mora obstajati možnost skrajšanja obdobja mirovanja.
To facilitate the smooth transition to the new requirements it is appropriate to provide for an adequate transitional period allowing for active implantable medical devices already covered by an EC design-examination certificate or by an EC type examination certificate to continue to be placed on the market and put into service.
Za nemoten prehod na nove zahteve je primerno zagotoviti ustrezno prehodno obdobje, v katerem se bodo aktivni medicinski pripomočki za vsaditev, ki so že zajeti v ES-certifikatu o pregledu načrtovanja ali ES-certifikatu o tipskem pregledu, lahko še naprej dajali na trg in v uporabo.
The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices set up by Article 6(2) of Directive 90/385/EEC,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Odbora za medicinske pripomočke, ustanovljenega s členom 6(2) Direktive 90/385/EGS –
This Regulation lays down particular requirements in relation to the placing on the market and/or putting into service of medical devices, including active implantable medical devices, manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
Ta uredba določa posebne zahteve v zvezi z dajanjem na trg in/ali v uporabo medicinskih pripomočkov, vključno z aktivnimi medicinskimi pripomočki za vsaditev, izdelanimi z uporabo živalskih tkiv, ki so neaktivni, ali neaktivnih proizvodov, pridobljenih iz živalskega tkiva.
This Regulation shall apply to animal tissues, as well as their derivatives, originating from bovine, ovine and caprine species, deer, elk, mink and cats.
Ta uredba se uporablja za živalska tkiva in njihove derivate, ki izvirajo iz vrst goveda, ovc in koz ter iz jelenjadi, losov, kun in mačk.
Collagen, gelatine and tallow used for the manufacturing of medical devices shall meet at least the requirements as fit for human consumption laid down in Regulation (EC) No 1069/2009.
Kolagen, želatina in loj, ki se uporabljajo za izdelavo medicinskih pripomočkov, morajo izpolnjevati vsaj zahteve glede primernosti za prehrano ljudi iz Uredbe (ES) št. 1069/2009.
Tallow derivatives, processed under conditions at least as vigorous as those laid down in Section 3 of Annex I;
derivate loja, predelane pod pogoji, ki so vsaj tako strogi kot pogoji iz oddelka 3 Priloge I;
medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.
medicinske pripomočke iz odstavka 1, ki niso namenjeni za stik s človeškim telesom ali so namenjeni le za stik z nepoškodovano kožo.
For the purposes of this Regulation, the following definitions apply in addition to the definitions set out in Directive 90/385/EEC and Directive 93/42/EEC:
V tej uredbi se poleg opredelitev pojmov iz Direktive 90/385/EGS in Direktive 93/42/EGS uporabljajo naslednje opredelitve pojmov:
‘cell’ means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;
„celica“ pomeni najmanjšo organizirano enoto kakršne koli živeče oblike, ki je sposobna za neodvisen obstoj in nadomestitev svoje lastne substance v ustreznem okolju;
‘tissue’ means an organisation of cells, extra-cellular constituents or both;
„tkivo“ pomeni organizacijo celic in/ali izvenceličnih sestavin;
‘derivative’ means a material obtained from animal tissue through one or more treatments, transformations or steps of processing;
„derivat“ pomeni snov, pridobljeno iz živalskega tkiva z vsaj eno obdelavo, pretvorbo ali fazo predelave;
‘non-viable’ means having no potential for metabolism or multiplication;
„neaktiven“ pomeni brez možnosti za metabolizem ali razmnoževanje;
‘TSEs’ means all transmissible spongiform encephalopathies as defined in Article 3(1)(a) of Regulation (EC) No 999/2001 of the European Parliament and of the Council [9];
„razne oblike TSE“ pomenijo vse transmisivne spongiformne encefalopatije iz člena 3(1)(a) Uredbe Evropskega parlamenta in Sveta (ES) št. 999/2001 [9];
‘TSE infectious agents’ means unclassified pathogenic agents which are capable of transmitting TSEs;
„povzročitelji okužbe s TSE“ pomenijo nerazvrščene patogene povzročitelje, ki so sposobni prenašati razne oblike TSE;
‘reduction, elimination or removal’ means a process by which the number of TSE infectious agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;
„zmanjšanje, odprava ali odstranitev“ pomeni postopek, s katerim se število povzročiteljev okužbe s TSE zmanjša, odpravi ali odstrani, da se prepreči okužba ali patogena reakcija;
‘inactivation’ means a process by which the ability to cause infection or pathogenic reaction by TSE infectious agents is reduced;
„inaktivacija“ pomeni postopek, s katerim se zmanjša sposobnost povzročiteljev okužbe s TSE za povzročitev okužbe ali patogene reakcije;
‘source country’ means the country or countries in which the animal was born, has been reared and/or has been slaughtered;
„izvorna država“ pomeni države, v katerih se je žival skotila, bila vzrejena in/ali zaklana;
‘starting materials’ means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in Article 1(1) are produced.
„vhodni materiali“ pomenijo surovine ali kateri koli drug proizvod živalskega izvora, iz katerega ali s pomočjo katerega se proizvedejo pripomočki iz člena 1(1).
Before lodging an application for a conformity assessment pursuant to Article 9(1) of Directive 90/385/EEC or Article 11(1) of Directive 93/42/EEC, the manufacturer of medical devices referred to in Article 1(1) of this Regulation or his authorised representative shall carry out the risk analysis and risk management scheme set out in Annex I to this Regulation.
Pred predložitvijo zahteve za ocenjevanje skladnosti po členu 9(1) Direktive 90/385/EGS ali členu 11(1) Direktive 93/42/EGS mora proizvajalec medicinskih pripomočkov iz člena 1(1) te uredbe ali njegov pooblaščeni zastopnik izvesti program analize in obvladovanja tveganj iz Priloge I k tej uredbi.
For custom-made devices and devices intended for clinical investigation which fall under Article 1(1), the statement of the manufacturer or his authorised representative and the documentation in accordance with Annex 6 to Directive 90/385/EEC or Annex VIII to Directive 93/42/EEC, respectively, shall also address compliance with the particular requirements set out in section 1 of Annex I to this Regulation.
V primeru pripomočkov, izdelanih za posameznega uporabnika, in pripomočkov, namenjenih za klinične raziskave, ki spadajo na področje uporabe člena 1(1), izjava proizvajalca ali njegovega pooblaščenega zastopnika in dokumentacija v skladu s Prilogo 6 k Direktivi 90/385/EGS oziroma Prilogo VIII k Direktivi 93/42/EGS obravnavata tudi skladnost s posebnimi zahtevami iz oddelka 1 Priloge I k tej uredbi.
Member States shall verify that bodies notified under Article 11 of Directive 90/385/EEC or Article 16 of Directive 93/42/EEC have up-to-date knowledge of the medical devices referred to in Article 1(1), in order to assess the conformity of those devices with the provisions of Directive 90/385/EEC or Directive 93/42/EEC, respectively, and with the particular requirements laid down in Annex I to this Regulation.
Države članice preverijo, ali imajo organi, priglašeni v skladu s členom 11 Direktive 90/385/EGS ali členom 16 Direktive 93/42/EGS, najnovejše znanje o medicinskih pripomočkih iz člena 1(1), da lahko ocenijo skladnost navedenih pripomočkov z določbami Direktive 90/385/EGS oziroma Direktive 93/42/EGS in s posebnimi zahtevami iz Priloge I k tej uredbi.
Member States shall regularly verify that those bodies maintain the required up-to-date knowledge and expertise.
Države članice redno preverjajo, ali ti organi vzdržujejo zahtevano strokovno in najnovejše znanje.
Where, on the basis of that verification, it is necessary for a Member State to amend the tasks of a notified body, that Member State shall notify the Commission and the other Member States accordingly.
Kadar mora država članica na podlagi navedenega preverjanja spremeniti naloge priglašenega organa, navedena država članica ustrezno obvesti Komisijo in druge države članice.
The Member States shall inform the Commission and the other Member States regarding the outcome of the verification referred to in the first sentence of paragraph 1 by 28 February 2013.
Države članice obvestijo Komisijo in druge države članice o izidu preverjanja iz prvega stavka odstavka 1 do 28. februarja 2013.
Conformity assessment procedures for medical devices referred to in Article 1(1) shall include the evaluation of compliance of the devices with the essential requirements of Directive 90/385/EEC or Directive 93/42/EEC, respectively, and the particular requirements laid down in Annex I to this Regulation.
Postopki ocenjevanja skladnosti za medicinske pripomočke iz člena 1(1) vključujejo ovrednotenje, ali pripomočki izpolnjujejo posebne zahteve iz Direktive 90/385/EGS oziroma Direktive 93/42/EGS in tehnične zahteve iz Priloge I k tej uredbi.
Notified bodies shall assess the documentation submitted by the manufacturer to verify that the benefits of the device outweigh the residual risks.
Priglašeni organi ocenijo dokumentacijo, ki jo predloži proizvajalec, da preverijo, ali je učinkovitost pripomočka večja od preostalih tveganj.
Particular account shall be taken of:
Predvsem se upoštevajo:
the manufacturer’s risk analysis and risk management process;
ocena tveganja in postopek obvladovanja tveganja proizvajalca;
the justification for the use of animal tissues or derivatives, taking into consideration lower risk tissues or synthetic alternatives;
utemeljitev uporabe živalskih tkiv ali derivatov, pri čemer se upoštevajo tkiva z nižjo stopnjo tveganja ali nadomestni sintetični materiali;
the results of elimination and inactivation studies or results of the analysis of relevant literature;
rezultati študij odprave in inaktivacije ali rezultati analize ustrezne literature;
the manufacturer’s control of the sources of raw materials, finished products, production process, testing, and subcontractors;
nadzor proizvajalca nad izvorom surovin, končnimi proizvodi, proizvodnim postopkom, testiranjem in podizvajalci;
the need to audit matters related to the sourcing and processing of animal tissues and derivatives, processes to eliminate or inactivate pathogens, including those activities carried out by suppliers.
potreba po presoji zadev v zvezi z izvorom in predelavo živalskih tkiv in derivatov, postopki za odpravo ali inaktivacijo patogenov, vključno z navedenimi dejavnostmi, ki jih opravljajo dobavitelji.
Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter ‘TSE certificate of suitability’, for starting materials, where available.
Priglašeni organi pri ovrednotenju analize in obvladovanja tveganja v okviru postopka ocenjevanja skladnosti upoštevajo certifikat o ustreznosti TSE, ki ga izda Evropski direktorat za kakovost zdravil, v nadaljevanju „certifikat o ustreznosti TSE“, za vhodne materiale, če je le-ta na voljo.
Where additional information is necessary to assess the suitability of the starting material for a given medical device, notified bodies may require submission of additional information to allow the evaluation as set out in paragraphs 1 and 2.
Kadar so za oceno ustreznosti vhodnega materiala za določen medicinski pripomoček potrebne dodatne informacije, priglašeni organi lahko zahtevajo predložitev dodatnih informacij, da se omogoči ovrednotenje iz odstavkov 1 in 2.
Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall, through their competent authority, hereinafter ‘coordinating competent authority’, inform the competent authorities of the other Member States and the Commission of their assessment carried out pursuant to paragraph 2 by means of a summary evaluation report in accordance with Annex II to this Regulation.
Pred izdajo ES-certifikata o pregledu načrtovanja ali ES-certifikata o tipskem pregledu priglašeni organi prek svojega pristojnega organa, v nadaljnjem besedilu „usklajevalnega pristojnega organa“, obvestijo pristojne organe drugih držav članic in Komisijo o svoji oceni, izvedeni v skladu z odstavkom 2 v obliki povzetka poročila o oceni iz Priloge II k tej uredbi.
The competent authorities of the Member States may submit comments on the summary evaluation report referred to in paragraph 4 within the following deadlines:
Pristojni organi držav članic lahko predložijo pripombe k povzetku poročila o oceni iz odstavka 4 v naslednjih rokih:
in relation to medical devices using starting materials for which a TSE certificate of suitability as referred to in paragraph 3 has been submitted, within four weeks from the date on which the notified body informed the coordinating competent authority pursuant to paragraph 4;
v zvezi z medicinskimi pripomočki, pri katerih so bili uporabljeni vhodni materiali, za katere je bil predložen certifikat o ustreznosti TSE iz odstavka 3, v štirih tednih od dne, ko priglašeni organ obvesti usklajevalni pristojni organ v skladu z odstavkom 4;
in relation to medical devices using starting materials for which a TSE certificate of suitability has not been submitted, within 12 weeks from the date on which the notified body informed the coordinating competent authority pursuant to paragraph 4.
v zvezi z medicinskimi pripomočki, pri katerih so bili uporabljeni vhodni materiali, za katere ni bil predložen certifikat o ustreznosti TSE, v dvanajstih tednih od dne, ko priglašeni organ obvesti usklajevalni pristojni organ v skladu z odstavkom 4.
The competent authorities of the Member States and the Commission may agree on shortening the time periods set out in points (a) and (b).
Pristojni organi držav članic in Komisija se lahko sporazumejo o skrajšanju rokov iz točk (a) in (b).
The notified bodies shall give due consideration to any comments received in accordance with paragraph 5.
Priglašeni organi ustrezno upoštevajo kakršne koli pripombe, prejete v skladu z odstavkom 5.
They shall convey an explanation as regards this consideration, including any due justification not to take account of one or more of the comments received, and their final decisions to the coordinating competent authority, which shall then make these available to the Commission and the competent authorities from which comments were received.
V zvezi s tem upoštevanjem usklajevalnemu pristojnemu organu posredujejo ustrezno mnenje, vključno s kakršno koli ustrezno utemeljitvijo neupoštevanja ene ali več prejetih pripomb, ter dokončne sklepe, usklajevalni pristojni organ pa jih nato posreduje Komisiji in pristojnim organom, od katerih so bile prejete pripombe.
The manufacturer shall collect, evaluate and submit to the notified body information regarding changes with regard to the animal tissue or derivatives used for the device or with regard to the TSE risk in relation to the device.
Proizvajalec zbere, ovrednoti in priglašenemu organu predloži informacije glede sprememb v zvezi z živalskim tkivom ali derivati, ki se uporabljajo za pripomoček, ali glede tveganja za TSE v zvezi s pripomočkom.
Where such information leads to an increase of the overall TSE risk, the provisions of paragraphs 1-6 are applicable.
Kadar je na podlagi takih informacij mogoče sklepati na povečanje splošnega tveganja za TSE, se uporabljajo določbe odstavkov 1 do 6.
Without prejudice to Article 7(2), Member States shall take all necessary steps to ensure that medical devices referred to in Article 1(1) are placed on the market and/or put into service only if they comply with the provisions of Directive 90/385/EEC or Directive 93/42/EEC, respectively, and the particular requirements laid down in this Regulation.
Brez poseganja v člen 7(2) države članice sprejmejo vse potrebne ukrepe za zagotovitev, da so medicinski pripomočki iz člena 1(1) dani na trg in/ali v uporabo le, če so v skladu z določbami Direktive 90/385/EGS oziroma Direktive 93/42/EGS in s posebnimi zahtevami iz te uredbe.
Holders of EC design-examination certificates or EC type-examination certificates issued before 29 August 2013 for active implantable medical devices referred to in Article 1(1) shall apply to their notified body for a complementary EC design-examination certificate or EC type-examination certificate attesting compliance with the particular requirements laid down in Annex I to this Regulation.
Imetniki ES-certifikatov o pregledu načrtovanja ali ES-certifikatov o tipskem pregledu, izdanih pred 29. avgustom 2013 za aktivne medicinske pripomočke za vsaditev iz člena 1(1) pri svojem priglašenem organu zahtevajo dopolnilni ES-certifikat o pregledu načrtovanja ali ES-certifikat o tipskem pregledu, ki dokazuje izpolnjevanje posebnih zahtev iz Priloge I k tej uredbi.
Until 29 August 2014, Member States shall accept the placing on the market and the putting into service of active implantable medical devices referred to in Article 1(1) which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 29 August 2013.
Do 29. avgusta 2014 države članice dovolijo dajanje na trg in v uporabo aktivnih medicinskih pripomočkov za vsaditev iz člena 1(1), ki imajo ES-certifikat o pregledu načrtovanja ali ES-certifikat o tipskem pregledu, izdan pred 29. avgustom 2013.
Directive 2003/32/EC is repealed with effect from 29 August 2013.
Direktiva 2003/32/ES se razveljavi z 29. avgustom 2013.
References to the repealed Directive are to be construed as references to this Regulation.
Sklicevanje na razveljavljeno direktivo se šteje za sklicevanje na to uredbo.
This Regulation enters into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
It shall apply from 29 August 2013 except for Article 4 which shall apply from the date of entry into force of this Regulation.
Uporablja se od 29. avgusta 2013, razen člena 4, ki se uporablja od datuma začetka veljavnosti te uredbe.
OJ L 105, 24.4.2003, p. 18.
UL L 105, 24.4.2003, str. 18.
Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3) (OJ C 73, 5.3.2011, p. 1).
Navodila o zmanjšanju tveganja prenosa povzročiteljev živalske spongiformne encefalopatije z zdravili za uporabo v humani in veterinarski medicini (EMA/410/01 rev. 3) (UL C 73, 5.3.2011, str. 1).
See http://ec.europa.eu/health/scientific_committees/emerging/opinions/scmpmd/index_en.htm
Glej http://ec.europa.eu/health/scientific_committees/emerging/opinions/scmpmd/index_en.htm.