natgillin/translations-raw huggingface dataset:
Member States shall ensure that where a genetic test is used on individuals, in the context of healthcare as defined in point (a) of Article 3 of Directive 2011/24/EU of the European Parliament and of the Council [23] and for the medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing, the individual being tested or, where applicable, his or her legally designated representative is provided with relevant information on the nature, the significance and the implications of the genetic test, as appropriate.
Države članice zagotovijo, da bo v primerih, ko se pri posameznikih v okviru zdravstvenega varstva, kot ga opredeljuje točka (a) člena 3 Direktive 2011/24/EU Evropskega parlamenta in Sveta [23], in za medicinske namene diagnosticiranja, izboljšanja zdravljenja, napovednega ali prenatalnega testiranja, uporabi genetski test, testirani posameznik ali po potrebi njegov zakonito imenovani zastopnik ustrezno obveščen o naravi, pomenu in posledicah genetskega testa, kakor je ustrezno.
In the context of the obligations referred to in paragraph 1, Member States shall, in particular, ensure that there is appropriate access to counselling in the case of the use of genetic tests that provide information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable according to the state of science and technology.
Države članice v zvezi z obveznostmi iz odstavka 1 zlasti zagotovijo, da je ustrezna možnost za svetovanje na voljo v primeru uporabe genetskega testa zaradi pridobivanja informacij o genetski predispoziciji za zdravstveno stanje in/ali bolezni, za katere na splošno velja, da jih glede na trenutno stanje v znanosti in tehnologiji ni mogoče ozdraviti.
Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease which the individual being tested is already known to have is confirmed by a genetic test or in cases where a companion diagnostic is used.
Odstavek 2 se ne uporablja v primerih, ko genetski testi potrdijo že znano diagnozo bolezenskega stanja in/ali bolezni testiranega posameznika, ali v primerih, ko se uporabi dopolnilna diagnostika.
Nothing in this Article shall prevent Member States from adopting or maintaining measures at national level which are more protective of patients, more specific or which deal with informed consent.
Ta člen ne preprečuje državam članicam, da na nacionalni ravni sprejmejo ali ohranijo ukrepe, ki bolj ščitijo pacienta, so bolj specifični ali urejajo privolitev po seznanitvi.
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE MARKING, FREE MOVEMENT
OMOGOČANJE DOSTOPNOSTI PRIPOMOČKOV NA TRGU IN NJIHOVO DAJANJE V UPORABO, OBVEZNOSTI GOSPODARSKIH SUBJEKTOV, OZNAKA CE, PROSTI PRETOK
Placing on the market and putting into service
Dajanje na trg in v uporabo
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.
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.
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.
Pripomoček ob upoštevanju predvidenega namena izpolnjuje splošne zahteve glede varnosti in učinkovitosti iz Priloge I, ki se uporabljajo zanj.
Demonstration of conformity with the general safety and performance requirements shall include a performance evaluation in accordance with Article 56.
Prikaz skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti vključuje klinično oceno v skladu s členom 56.
Devices that are manufactured and used within health institutions, with the exception of devices for performance studies, shall be considered as having been put into service.
Za pripomočke, ki se proizvajajo in uporabljajo v zdravstvenih ustanovah, razen za pripomočke za študije učinkovitosti, se šteje, da so dani v uporabo.
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:
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:
the devices are not transferred to another legal entity;
pripomočki niso preneseni na drug pravni subjekt,
manufacture and use of the devices occur under appropriate quality management systems;
pripomočki so proizvedeni in se uporabljajo v okviru ustreznih sistemov vodenja kakovosti,
the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation;
laboratorij zdravstvene ustanove izpolnjuje zahteve iz standarda EN ISO 15189 ali po potrebi nacionalnih določb, tudi nacionalnih določb glede akreditacije,
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;
v dokumentaciji zdravstvene ustanove je utemeljeno, da specifičnih potreb ciljne skupine pacientov ni mogoče dovolj učinkovito zadovoljiti z enakovrednim pripomočkom, ki je dostopen na trgu,
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;
zdravstvena ustanova pristojnemu organu na zahtevo sporoči informacije o uporabi takšnih pripomočkov, kar vključuje tudi utemeljitev njihove proizvodnje, spremembe in uporabe,
the health institution draws up a declaration which it shall make publicly available, including:
zdravstvena ustanova da izjavo, da bo med drugim objavila:
the name and address of the manufacturing health institution,
naziv in naslov zdravstvene ustanove proizvajalke;
the details necessary to identify the devices,
podatke, nujne za identifikacijo pripomočkov;
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;
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;
as regards class D devices in accordance with the rules set out in Annex VIII, 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.
glede pripomočkov razreda D v skladu s pravili iz Priloge VIII, 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.
Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;
Države članice lahko to določbo uporabijo tudi za pripomočke A, B ali C razreda v skladu s pravili iz Priloge VIII;
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g); and
zdravstvena ustanova z vsemi potrebnimi ukrepi zagotovi, da so vsi pripomočki proizvedeni v skladu z dokumentacijo iz točke (g), in
the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
zdravstvena ustanova preuči izkušnje, pridobljene pri klinični uporabi pripomočkov, ter sprejme vse potrebne korektivne ukrepe.
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.
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.
Member States shall retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.
Države članice si pridržijo pravico, da omejijo proizvodnjo in uporabo vseh posameznih vrst teh pripomočkov, dovoljen pa jim je tudi dostop do zdravstvenih ustanov, da lahko opravijo inšpekcijske preglede njihovih dejavnosti.
This paragraph shall not apply to devices that are manufactured on an industrial scale.
Ta odstavek se ne uporablja za pripomočke, ki se proizvajajo na industrijski ravni.
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.
Da bi zagotovila enotno uporabo Priloge I, lahko Komisija sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe.
Distance sales
Prodaja na daljavo
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.
Pripomoček, ki je fizični ali pravni osebi s sedežem v Uniji na voljo prek storitev informacijske družbe, kot je opredeljena v točki (b) člena 1(1) Direktive (EU) 2015/1535, je skladen s to uredbo.
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.
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, ali prek drugih sredstev sporočanja, skladen s to uredbo.
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.
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.
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.
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.
Claims
Navedbe
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:
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:
ascribing functions and properties to the device which the device does not have;
bi pripomočku pripisovali funkcije in lastnosti, ki jih ta nima;
creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
bi dajali lažen vtis glede zdravljenja ali diagnoze, funkcij ali lastnosti, ki jih pripomoček nima;
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;
uporabnika ali pacienta ne bi seznanjali z verjetnim tveganjem, povezanim z uporabo pripomočka v skladu z njegovim predvidenim namenom;
suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
bi navajali uporabo pripomočka, ki je v nasprotju z uporabo, navedeno kot del predvidenega namena, za katerega je bilo opravljeno ugotavljanje skladnosti.
Use of harmonised standards
Uporaba harmoniziranih standardov
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 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.
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, performance studies, clinical evidence or post-market performance follow-up (‘PMPF’).
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 za nadzor po dajanju na trg, študije učinkovitosti, klinične dokaze ali spremljanje učinkovitosti po dajanju na trg.
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.
Sklicevanja na harmonizirane standarde v tej uredbi se štejejo, da pomenijo harmonizirane standarde, katerih sklicevanja so bila objavljena v Uradnem listu Evropske unije.
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, provided that references to those monographs have been published in the Official Journal of the European Union.
Sklicevanje na harmonizirane standarde v tej uredbi vključuje tudi monografije Evropske farmakopeje, sprejete v skladu s Konvencijo o izdelavi Evropske farmakopeje, če so bila sklicevanja na navedene monografije objavljena v Uradnem listu Evropske unije.
Common specifications
Skupne specifikacije
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 performance evaluation and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annex XIII.
Če harmoniziranih standardov ni ali ne zadoščajo ali če se je treba odzvati na pereče zadeve, povezane z javnim zdravjem, lahko Komisija 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, oceno učinkovitosti in spremljanje učinkovitosti po dajanju na trg, določena v Prilogi XIII, ali zahteve glede študij učinkovitosti, določene v Prilogi XIII.
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.
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.
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.
Proizvajalci izpolnjujejo skupne specifikacije iz odstavka 1, razen če lahko ustrezno utemeljijo, da so sprejeli rešitve, ki zagotavljajo vsaj enakovredno raven varnosti in učinkovitosti.
General obligations of manufacturers
Splošne obveznosti proizvajalcev
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 pri dajanju pripomočkov na trg ali v uporabo zagotovijo, da so bili ti zasnovani in izdelani v skladu z zahtevami te uredbe.
Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.
Proizvajalci vzpostavijo, dokumentirajo, izvajajo in vzdržujejo sistem za obvladovanje tveganja, kot je opisano v oddelku 3 Priloge I.
Manufacturers shall conduct a performance evaluation in accordance with the requirements set out in Article 56 and Annex XIII, including a PMPF.
Proizvajalci izvedejo oceno učinkovitosti v skladu z zahtevami iz člena 56 in Priloge XIII, vključno s spremljanjem učinkovitosti po dajanju na trg.
Manufacturers shall draw up and keep up to date the technical documentation for those devices.
Proizvajalci sestavijo in posodabljajo tehnično dokumentacijo za te pripomočke.
The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed.
Tehnična dokumentacija mora biti taka, da omogoča ugotavljanje skladnosti pripomočka z zahtevami iz te uredbe.
The technical documentation shall include the elements set out in Annexes II and III.
Tehnična dokumentacija vsebuje elemente, določene v prilogah II in III.
The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress, the Annexes II and III.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 108, s katerimi zaradi tehničnega napredka spremeni prilogi II in III.
Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devices for performance study, shall draw up an EU declaration of conformity in accordance with Article 17, and affix the CE marking of conformity in accordance with Article 18.
Če je bila skladnost z veljavnimi zahtevami dokazana z veljavnim postopkom ugotavljanja skladnosti, proizvajalci pripomočkov, razen pripomočkov za študijo učinkovitosti, v skladu s členom 17 sestavijo izjavo EU o skladnosti in v skladu s členom 18 namestijo oznako skladnosti CE.
Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 24 and with the registration obligations referred to in Article 26 and 28.
Proizvajalci izpolnjujejo obveznosti glede sistema UDI iz člena 24 ter obveznosti glede registracije iz členov 26 in 28.
Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, 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.
Proizvajalci hranijo tehnično dokumentacijo, izjavo EU o skladnosti in, kjer je potrebno, izvod ustreznega certifikata, vključno z morebitnimi spremembami in dopolnili, izdanimi v skladu s členom 51, ki so 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.
Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof.
Proizvajalec na zahtevo pristojnega organa navedeno tehnično dokumentacijo predloži v celoti ali predloži samo njen povzetek, kot je navedeno v zahtevi.
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.
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).
Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation.
Proizvajalci zagotovijo, da se vzpostavijo postopki, s katerimi serijska proizvodnja ostaja skladna z zahtevami iz te uredbe.
Changes in product design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a product is declared shall be adequately taken into account in a timely manner.
Ustrezno in pravočasno se upoštevajo tudi spremembe zasnove ali lastnosti izdelka ter spremembe harmoniziranih standardov ali skupnih specifikacij, s katerimi je izdelek skladen.
Manufacturers of devices, other than devices for performance study, 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.
Proizvajalci pripomočkov, razen pripomočkov za študijo učinkovitosti, 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.
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 zajema vse dele in elemente organizacije proizvajalca, ki se ukvarjajo s kakovostjo procesov, postopkov in pripomočkov.