natgillin/translations-raw huggingface dataset:
The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article.
Komisija zagotovi izmenjavo strokovnega znanja med državami članicami na področju medicinskih pripomočkov, in vitro diagnostičnih medicinskih pripomočkov, zdravil, človeških tkiv in celic, kozmetičnih izdelkov, biocidov, živil in po potrebi drugih izdelkov, da tako določi ustrezen regulativni status izdelka oziroma kategorije ali skupine izdelkov.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Pri odločanju o možnem regulativnem statusu kot pripomoček za izdelke, ki vključujejo zdravila, človeška tkiva in celice, biocide ali živila, Komisija zagotovi ustrezno raven posvetovanja z Evropsko agencijo za zdravila (EMA), Evropsko agencijo za kemikalije (ECHA) in Evropsko agencijo za varnost hrane (EFSA), kakor je ustrezno.
The Commission shall ensure that Member States share expertise in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products.
POGLAVJE II
When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), as relevant.
OMOGOČANJE DOSTOPNOSTI PRIPOMOČKOV NA TRGU IN NJIHOVO DAJANJE V UPORABO OBVEZNOSTI GOSPODARSKIH SUBJEKTOV, PONOVNA OBDELAVA, OZNAKA CE, PROSTI PRETOK
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT
Dajanje na trg in v uporabo
Article 5
Pripomoček se lahko da na trg ali v uporabo samo, če je skladen s to uredbo, kadar je ustrezno dobavljen in pravilno nameščen, vzdrževan in uporabljen v skladu s predvidenim namenom.
Placing on the market and putting into service
Pripomoček ob upoštevanju predvidenega namena izpolnjuje splošne zahteve glede varnosti in učinkovitosti iz Priloge I, ki se uporabljajo zanj.
A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
Dokazovanje skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti vključuje klinično oceno v skladu s členom 61.
A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.
Za pripomočke, ki se proizvajajo in uporabljajo v zdravstvenih ustanovah, se šteje, da so dani v uporabo.
Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.
Z izjemo ustreznih splošnih zahtev glede varnosti in učinkovitosti, določenih v Prilogi I, se zahteve iz te uredbe ne uporabljajo za pripomočke, ki se proizvajajo in uporabljajo le v zdravstvenih ustanovah s sedežem v Uniji, pod pogojem, da so izpolnjeni vsi naslednji pogoji:
Devices that are manufactured and used within health institutions shall be considered as having been put into service.
pripomočki niso preneseni na drug pravni subjekt,
With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:
pripomočki so proizvedeni in se uporabljajo v okviru ustreznih sistemov vodenja kakovosti,
the devices are not transferred to another legal entity,
v dokumentaciji zdravstvene ustanove je utemeljeno, da specifičnih potreb ciljne skupine pacientov ni mogoče zadovoljiti – ali vsaj ne dovolj učinkovito – z enakovrednim pripomočkom, ki je dostopen na trgu,
manufacture and use of the devices occur under appropriate quality management systems,
zdravstvena ustanova pristojnemu organu na zahtevo sporoči informacije o uporabi takšnih pripomočkov, kar vključuje tudi utemeljitev njihove proizvodnje, spremembe in uporabe,
the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,
zdravstvena ustanova da izjavo, da bo med drugim objavila:
the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;
naziv in naslov zdravstvene ustanove proizvajalke;
the health institution draws up a declaration which it shall make publicly available, including:
podatke, nujne za identifikacijo pripomočkov;
the name and address of the manufacturing health institution;
izjavo, da so pripomočki skladni s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I k tej uredbi, in, kjer je to ustrezno, informacije o tem, katere zahteve niso v celoti izpolnjene, z ustrezno obrazložitvijo za to,
the details necessary to identify the devices;
zdravstvena ustanova pripravi dokumentacijo, iz katere je mogoče pridobiti informacije o proizvodnih prostorih, postopku izdelave, podatke o zasnovi in učinkovitosti pripomočkov, vključno s predvidenim namenom, in ki mora biti dovolj podrobna, da lahko pristojni organ oceni, ali so izpolnjene splošne zahteve glede varnosti in učinkovitosti iz Priloge I k tej uredbi,
a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,
zdravstvena ustanova z vsemi potrebnimi ukrepi zagotovi, da so vsi pripomočki proizvedeni v skladu z dokumentacijo iz točke (f), in
the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;
zdravstvena ustanova preuči izkušnje, pridobljene pri klinični uporabi pripomočkov, ter sprejme vse potrebne korektivne ukrepe.
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and
Države članice lahko zahtevajo, da takšne zdravstvene ustanove pristojnemu organu predložijo morebitne druge ustrezne informacije o teh pripomočkih, ki se proizvajajo ali uporabljajo na njihovem ozemlju.
the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
Države članice si pridržijo pravico, da omejijo proizvodnjo in uporabo posameznih vrst teh pripomočkov, dovoljen pa jim je tudi dostop do zdravstvenih ustanov, da lahko opravijo inšpekcijske preglede njihovih dejavnosti.
Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory.
Ta odstavek se ne uporablja za pripomočke, ki se proizvajajo na industrijski ravni.
Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.
Da bi Komisija zagotovila enotno uporabo Priloge I, lahko sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe.
This paragraph shall not apply to devices that are manufactured on an industrial scale.
Člen 6
In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
Prodaja na daljavo
Article 6
Pripomoček, ki je fizični ali pravni osebi s sedežem v Uniji na voljo prek storitev informacijske družbe, kot so opredeljene v točki (b) člena 1(1) Direktive (EU) 2015/1535, je skladen s to uredbo.
Distance sales
Brez poseganja v nacionalno pravo glede izvajanja zdravstvenega poklica je pripomoček, ki se ne da na trg, temveč se bodisi za plačilo bodisi brezplačno uporablja v okviru trgovske dejavnosti za zagotavljanje diagnostične ali terapevtske storitve, ponujene bodisi neposredno bodisi prek posrednikov fizični ali pravni osebi s sedežem v Uniji prek storitev informacijske družbe, kot so opredeljene v točki (b) člena 1(1) Direktive (EU) 2015/1535, skladen s to uredbo.
A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation.
Vsaka fizična ali pravna oseba, ki da na voljo pripomoček v skladu z odstavkom 1 ali opravlja storitev v skladu z odstavkom 2, na zahtevo pristojnega organa omogoči dostop do izvoda izjave EU o skladnosti zadevnega pripomočka.
Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation.
Država članica lahko iz razlogov varovanja javnega zdravja zahteva, naj ponudnik storitev informacijske družbe, kot so opredeljene v točki (b) člena 1(1) Direktive (EU) 2015/1535, preneha opravljati svojo dejavnost.
Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned.
Člen 7
A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
Navedbe
Article 7
Pri označevanju, v navodilih za uporabo, pri omogočanju dostopnosti, dajanju v uporabo in oglaševanju pripomočkov je prepovedana uporaba besedil, imen, blagovnih znamk, slikovnega materiala in simbolov ali drugih znakov, ki bi uporabnika ali pacienta lahko zavedli glede predvidenega namena, varnosti in učinkovitosti pripomočka, ker:
Claims
bi pripomočku pripisovali funkcije in lastnosti, ki jih ta nima;
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
bi dajali lažen vtis glede zdravljenja ali diagnoze, funkcij ali lastnosti, ki jih pripomoček nima;
ascribing functions and properties to the device which the device does not have;
uporabnika ali pacienta ne bi seznanjali z verjetnim tveganjem, povezanim z uporabo pripomočka v skladu z njegovim predvidenim namenom;
creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
bi navajali uporabo pripomočka, ki je v nasprotju z uporabo, navedeno kot del predvidenega namena, za katerega je bilo opravljeno ugotavljanje skladnosti.
failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
Člen 8
suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
Uporaba harmoniziranih standardov
Article 8
Za pripomočke, ki so v skladu z ustreznimi harmoniziranimi standardi ali ustreznimi deli teh standardov, katerih sklicevanja so bila objavljena v Uradnem listu Evropske unije, se domneva, da so skladni z zahtevami iz te uredbe, zajetimi v navedenih standardih ali njihovih delih.
Use of harmonised standards
Prvi pododstavek se uporablja tudi za zahteve glede sistema ali postopka, ki jih morajo v skladu s to uredbo izpolnjevati gospodarski subjekti ali sponzorji, vključno s tistimi, ki zadevajo sisteme vodenja kakovosti, obvladovanje tveganja, sisteme nadzora po dajanju na trg, klinične raziskave, klinično oceno ali klinično spremljanje po dajanju na trg.
Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
Za sklicevanja na harmonizirane standarde v tej uredbi se šteje, da pomenijo harmonizirane standarde, katerih sklicevanja so bila objavljena v Uradnem listu Evropske unije.
The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).
Sklicevanja na harmonizirane standarde v tej uredbi vključujejo tudi monografije Evropske farmakopeje, sprejete v skladu s Konvencijo o izdelavi Evropske farmakopeje, zlasti o kirurških šivalnih materialih in medsebojnem učinkovanju zdravil in materialov, uporabljenih v pripomočkih, ki vsebujejo takšna zdravila, če so sklicevanja na navedene monografije objavljena v Uradnem listu Evropske unije.
References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.
Člen 9
References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union.
Skupne specifikacije
Article 9
Če harmoniziranih standardov ni ali ne zadoščajo ali če se je treba odzvati na pereče zadeve, povezane z javnim zdravjem, lahko Komisija brez poseganja v člen 1(2) in 17(5) ter v rok, ki je predpisan v teh določbah, in po posvetovanju s Koordinacijsko skupino za medicinske pripomočke z izvedbenimi akti sprejme skupne specifikacije za splošne zahteve glede varnosti in učinkovitosti, določene v Prilogi I, tehnično dokumentacijo, določeno v prilogah II in III, klinično oceno in klinično spremljanje po dajanju na trg, določeno v Prilogi XIV, ali zahteve glede kliničnih raziskav, določene v Prilogi XV.
Common specifications
Za pripomočke, ki so skladni s skupnimi specifikacijami iz odstavka 1, se šteje, da so skladni z zahtevami iz te uredbe, zajetimi v navedenih skupnih specifikacijah ali ustreznih delih teh skupnih specifikacij.
Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV.
Proizvajalci izpolnjujejo skupne specifikacije iz odstavka 1, razen če lahko ustrezno utemeljijo, da so sprejeli rešitve, ki zagotavljajo vsaj enakovredno raven varnosti in učinkovitosti.
Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.
Ne glede na odstavek 3 proizvajalci izdelkov iz Priloge XVI izpolnjujejo ustrezne skupne specifikacije za te izdelke.
Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.
Člen 10
Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products.
Splošne obveznosti proizvajalcev
Article 10
Proizvajalci pri dajanju pripomočkov na trg ali v uporabo zagotovijo, da so bili ti zasnovani in izdelani v skladu z zahtevami te uredbe.
General obligations of manufacturers
Proizvajalci vzpostavijo, dokumentirajo, izvajajo in vzdržujejo sistem za obvladovanje tveganja, kot je opisano v oddelku 3 Priloge I.
When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.
Proizvajalci izvedejo klinično oceno v skladu z zahtevami iz člena 61 in Priloge XIV, vključno s kliničnim spremljanjem po dajanju na trg.
Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.
Proizvajalci pripomočkov, razen pripomočkov, izdelanih za posameznega uporabnika, sestavijo in posodabljajo tehnično dokumentacijo za te pripomočke.
Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.
Tehnična dokumentacija mora biti taka, da omogoča ugotavljanje skladnosti pripomočka z zahtevami iz te uredbe.
Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices.
Tehnična dokumentacija vsebuje elemente, določene v prilogah II in III.
The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115, s katerimi glede na tehnični napredek spremeni prilogi II in III.
The technical documentation shall include the elements set out in Annexes II and III.
Proizvajalci pripomočkov, izdelanih za posameznega uporabnika, sestavijo, posodabljajo in pristojnim organom dajejo na razpolago dokumentacijo v skladu z oddelkom 2 Priloge XIII.
The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III.
Če je bila skladnost z veljavnimi zahtevami dokazana z veljavnim postopkom ugotavljanja skladnosti, proizvajalci pripomočkov, razen pripomočkov, izdelanih za posameznega uporabnika, in pripomočkov, ki so predmet raziskave, v skladu s členom 19 sestavijo izjavo EU o skladnosti in v skladu s členom 20 namestijo oznako CE.
Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII.
Proizvajalci izpolnjujejo obveznosti glede sistema UDI iz člena 27 ter obveznosti glede registracije iz členov 29 in 31.
Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.
Proizvajalci zagotovijo, da so tehnična dokumentacija, izjava EU o skladnosti in, kjer je potrebno, izvod ustreznega certifikata, vključno z morebitnimi spremembami in dopolnili, izdanimi v skladu s členom 56, pristojnim organom na voljo najmanj deset let po tem, ko je bil na trg dan zadnji pripomoček, na katerega se izjava EU o skladnosti nanaša.
Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31.
V primeru pripomočkov za vsaditev je to obdobje najmanj 15 let po tem, ko je bil na trg dan zadnji pripomoček.
Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market.
Proizvajalec na zahtevo pristojnega organa navedeno tehnično dokumentacijo predloži v celoti ali predloži samo njen povzetek, kot je navedeno v zahtevi.
In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.
Proizvajalec, ki ima registrirani kraj poslovanja zunaj Unije, poskrbi, da ima njegov pooblaščeni predstavnik ves čas na voljo potrebno dokumentacijo za izpolnjevanje nalog iz člena 11(3).
Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof.
Proizvajalci zagotovijo, da se vzpostavijo postopki, s katerimi serijska proizvodnja ostaja skladna z zahtevami iz te uredbe.
A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.
Ustrezno in pravočasno se upoštevajo tudi spremembe zasnove ali lastnosti pripomočka ter spremembe harmoniziranih standardov ali skupnih specifikacij, na podlagi katerih pripomoček šteje za skladnega.
Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation.
Proizvajalci pripomočkov, razen pripomočkov, ki so predmet raziskave, vzpostavijo, dokumentirajo, izvajajo, vzdržujejo posodabljajo in nenehno izboljšujejo sistem vodenja kakovosti, s katerim na najučinkovitejši način in na način, sorazmeren z razredom tveganja in ustrezen vrsti pripomočka, zagotovijo skladnost s to uredbo.
Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner.
Sistem vodenja kakovosti zajema vse dele in elemente organizacije proizvajalca, ki se ukvarjajo s kakovostjo procesov, postopkov in pripomočkov.
Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
Uporablja se za upravljanje strukture, odgovornosti, postopkov, procesov in sredstev za upravljanje, zahtevanih za uveljavitev načel in ukrepov, ki so potrebni za zagotovitev skladnosti z določbami te uredbe.
The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices.
Sistem vodenja kakovosti vključuje vsaj naslednje vidike: