natgillin/translations-raw huggingface dataset:
Where, within two months of receipt of the notification referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of any measures taken by a Member State, those measures shall be deemed to be justified.
Kadar država članica v dveh mesecih od prejema uradnega obvestila iz člena 90(4) vloži ugovor proti ukrepu, ki ga je sprejela druga država članica, ali kadar Komisija meni, da je ukrep v nasprotju s pravom Unije, Komisija po posvetovanju z zadevnimi pristojnimi organi in po potrebi z zadevnimi gospodarskimi subjekti oceni ta nacionalni ukrep.
In that case, all Member States shall ensure that corresponding appropriate restrictive or prohibitive measures, including withdrawing, recalling or limiting the availability of the device on their national market are taken without delay in respect of the device concerned.
Na podlagi rezultatov navedene ocene lahko Komisija z izvedbenimi akti odloči, ali je nacionalni ukrep upravičen ali ne.
Article 91
Če Komisija meni, da je nacionalni ukrep upravičen, kot je navedeno v odstavku 1 tega člena, se uporablja drugi pododstavek člena 90(7).
Procedure for evaluating national measures at Union level
Če Komisija meni, da nacionalni ukrep ni upravičen, ga zadevna država članica umakne.
Where, within two months of receipt of the notification referred to in Article 90(4), objections are raised by a Member State against a measure taken by another Member State, or where the Commission considers the measure to be contrary to Union law, the Commission shall, after consulting the competent authorities concerned and, where necessary, the economic operators concerned, evaluate that national measure.
Če Komisija ne sprejme odločitve v skladu z odstavkom 1 tega člena v osmih mesecih od prejema uradnega obvestila iz člena 90(4), se šteje, da so nacionalni ukrepi upravičeni.
On the basis of the results of that evaluation, the Commission may decide, by means of implementing acts, whether or not the national measure is justified.
Če država članica ali Komisija meni, da tveganja za zdravje in varnost zaradi uporabe pripomočka ni mogoče zadovoljivo zmanjšati z ukrepi, ki jih sprejme zadevna država članica ali države članice, lahko Komisija na zahtevo države članice ali na lastno pobudo z izvedbenimi akti sprejme potrebne in ustrezno utemeljene ukrepe za zagotovitev varovanja zdravja in varnosti, vključno z ukrepi za omejitev ali prepoved dajanja zadevnega pripomočka na trg ali v uporabo.
Where the Commission considers the national measure to be justified as referred to in paragraph 1 of this Article, the second subparagraph of Article 90(7) shall apply.
Člen 92
If the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure.
Druge neskladnosti
Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt of the notification referred to in Article 90(4), the national measure shall be considered to be justified.
Kadar pristojni organi države članice po oceni v skladu s členom 89 menijo, da pripomoček ne izpolnjuje zahtev iz te uredbe, vendar pa ne pomeni nesprejemljivega tveganja za zdravje ali varnost pacientov, uporabnikov ali drugih oseb ali za druge vidike varovanja javnega zdravja, od zadevnega gospodarskega subjekta zahtevajo, naj zadevno neskladnost odpravi v razumnem roku, ki je sorazmeren z neskladnostjo ter je jasno določen in sporočen gospodarskemu subjektu.
Where a Member State or the Commission considers that the risk to health and safety emanating from a device cannot be mitigated satisfactorily by means of measures taken by the Member State or Member States concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of implementing acts, the necessary and duly justified measures to ensure the protection of health and safety, including measures restricting or prohibiting the placing on the market and putting into service of the device concerned.
Če gospodarski subjekt ne odpravi neskladnosti v obdobju iz odstavka 1 tega člena, zadevna država članica nemudoma sprejme vse ustrezne ukrepe za omejitev ali prepoved dostopnosti izdelka na trgu oziroma zagotovi njegov odpoklic ali umik s trga.
Article 92
Navedene ukrepe nemudoma sporoči Komisiji in drugim državam članicam prek elektronskega sistema iz člena 95.
Other non-compliance
Da se zagotovi enotna uporaba tega člena, lahko Komisija z izvedbenimi akti opredeli ustrezne ukrepe, ki jih morajo sprejeti pristojni organi za obravnavo določenih vrst neskladnosti.
Where, having performed an evaluation pursuant to Article 89, the competent authorities of a Member State find that a device does not comply with the requirements laid down in this Regulation but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance.
Člen 93
Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph 1 of this Article, the Member State concerned shall without delay take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market.
Preventivni ukrepi za varovanje zdravja
That Member State shall inform the Commission and the other Member States without delay of those measures, by means of the electronic system referred to in Article 95.
Kadar država članica po oceni, ki je pokazala na morebitno tveganje, povezano s pripomočkom oziroma s posebno kategorijo ali skupino pripomočkov, meni, da bi bilo treba zaradi varovanja zdravja in varnosti pacientov, uporabnikov ali drugih oseb ali drugih vidikov javnega zdravja dostopnost na trgu ali dajanje v uporabo pripomočka oziroma posebne kategorije ali skupine pripomočkov prepovedati, omejiti ali odobriti pod posebnimi zahtevami ali da bi bilo treba tak pripomoček oziroma tako kategorijo ali skupino pripomočkov umakniti s trga ali odpoklicati, lahko sprejme vse potrebne in upravičene ukrepe.
In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance.
Država članica iz odstavka 1 nemudoma prek elektronskega sistema iz člena 95 uradno obvesti Komisijo in druge države članice o sprejetih ukrepih in razlogih za tako odločitev.
Article 93
Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke in po potrebi z zadevnimi gospodarskimi subjekti oceni sprejete nacionalne ukrepe.
Preventive health protection measures
Komisija lahko z izvedbenimi akti odloči, ali so nacionalni ukrepi upravičeni ali ne.
Where a Member State, after having performed an evaluation, which indicates a potential risk related to a device or a specific category or group of devices considers that, in order to protect the health and safety of patients, users or other persons or other aspects of public health, the making available on the market or putting into service of a device or a specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled, it may take any necessary and justified measures.
Če Komisija v šestih mesecih po uradnem obvestilu ne sprejme odločitve, se šteje, da so nacionalni ukrepi upravičeni.
The Member State referred to in paragraph 1 shall immediately notify the Commission and all other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 95.
Kadar rezultati ocene iz odstavka 3 tega člena kažejo, da bi bilo treba zaradi varovanja zdravja in varnosti pacientov, uporabnikov in drugih oseb ali drugih vidikov javnega zdravja dostopnost na trgu ali dajanje v uporabo pripomočka oziroma posebne kategorije ali skupine pripomočkov prepovedati ali omejiti ali odobriti pod posebnimi zahtevami ali da bi bilo treba pripomoček oziroma kategorijo ali skupino pripomočkov umakniti s trga ali odpoklicati iz vseh držav članic, lahko Komisija sprejme izvedbene akte za sprejetje potrebnih in ustrezno utemeljenih ukrepov.
The Commission, in consultation with the MDCG and, where necessary, the economic operators concerned, shall assess the national measures taken.
Člen 94
The Commission may decide, by means of implementing acts, whether the national measures are justified or not.
Dobra upravna praksa
In the absence of a Commission decision within six months of their notification, the national measures shall be considered to be justified.
V vseh ukrepih, ki jih sprejmejo pristojni organi držav članic na podlagi členov 90 do 93, se navedejo natančni razlogi za njihovo sprejetje.
Where the assessment referred to in paragraph 3 of this Article demonstrates that the making available on the market or putting into service of a device, specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in all Member States in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission may adopt implementing acts) to take the necessary and duly justified measures.
Kadar je ukrep naslovljen na določen gospodarski subjekt, pristojni organ nemudoma uradno obvesti zadevni gospodarski subjekt o tem ukrepu ter hkrati seznani zadevni gospodarski subjekt s pravnimi sredstvi, ki so mu na voljo v skladu s pravom ali upravno prakso zadevne države članice, in z roki, ki se za ta pravna sredstva uporabljajo.
Article 94
Če se ukrep splošno uporablja, se ustrezno objavi.
Good administrative practice
Razen kadar je potrebno takojšnje ukrepanje zaradi nesprejemljivega tveganja za zdravje ali varnost ljudi, se zadevnemu gospodarskemu subjektu zagotovi možnost, da pred sprejetjem kakršnega koli ukrepa svoje pripombe v ustreznem in jasno določenem roku predloži pristojnemu organu.
Any measure adopted by the competent authorities of the Member States pursuant to Articles 90 to 93 shall state the exact grounds on which it is based.
Če je bil ukrep sprejet, ne da bi imel gospodarski subjekt možnost predložitve pripomb v skladu s prvim pododstavkom, se mu omogoči, da pripombe predloži čim prej, sprejeti ukrep pa se nato takoj pregleda.
Where such a measure is addressed to a specific economic operator, the competent authority shall notify without delay the economic operator concerned of that measure, and shall at the same time inform that economic operator of the remedies available under the law or the administrative practice of the Member State concerned and of the time limits to which such remedies are subject.
Vsak sprejeti ukrep se takoj prekliče ali spremeni, ko gospodarski subjekt dokaže, da je sprejel učinkovite korektivne ukrepe in da je pripomoček skladen z zahtevami iz te uredbe.
Where the measure is of general applicability, it shall be appropriately published.
Kadar ukrep, sprejet na podlagi členov 90 do 93, zadeva pripomoček, pri katerem je v postopku ugotavljanja skladnosti sodeloval priglašeni organ, pristojni organi o sprejetem ukrepu prek elektronskega sistema iz člena 95 obvestijo ustrezni priglašeni organ in organ, pristojen za priglašeni organ.
Except in cases where immediate action is necessary for reasons of unacceptable risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time that is clearly defined before any measure is adopted.
Člen 95
Where action has been taken without the economic operator having had the opportunity to make submissions as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter.
Elektronski sistem za nadzor trga
Any measure adopted shall be immediately withdrawn or amended upon the economic operator's demonstrating that it has taken effective corrective action and that the device is in compliance with the requirements of this Regulation.
Komisija v sodelovanju z državami članicami vzpostavi in upravlja elektronski sistem za zbiranje in obdelavo naslednjih informacij:
Where a measure adopted pursuant to Articles 90 to 93 concerns a device for which a notified body has been involved in the conformity assessment, the competent authorities shall by means of the electronic system referred to in Article 95 inform the relevant notified body and the authority responsible for the notified body of the measure taken.
povzetkov rezultatov dejavnosti nadzora iz člena 88(4);
Article 95
končnega poročila o inšpekcijskem pregledu iz člena 88(7);
Electronic system on market surveillance
informacij o pripomočkih, ki pomenijo nesprejemljivo tveganje za zdravje in varnost, kot je navedeno v členu 90(2), (4) in (6);
The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
informacij o izdelkih, ki ne izpolnjujejo zahtev, kot je navedeno v členu 92(2);
summaries of the results of the surveillance activities referred to in Article 88(4);
informacije o preventivnih ukrepih za varovanje zdravja, kot je navedeno v členu 93(2);
the final inspection report as referred to in Article 88(7);
povzetkov rezultatov pregledov in ocen dejavnosti nadzora trga držav članic iz člena 88(8).
information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 90(2), (4) and (6);
Informacije iz odstavka 1 tega člena se prek elektronskega sistema nemudoma pošljejo vsem zadevnim pristojnim organom in, kadar je ustrezno, priglašenemu organu, ki je izdal certifikat za zadevni pripomoček v skladu s členom 51, in so dostopne državam članicam in Komisiji.
information in relation to non-compliance of products as referred to in Article 92(2);
Informacije, ki si jih izmenjajo države članice, se ne objavijo, če bi lahko objava škodila dejavnostim nadzora trga in sodelovanju med državami članicami.
information in relation to the preventive health protection measures referred to in Article 93(2);
POGLAVJE VIII
summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in Article 88(8).
SODELOVANJE MED DRŽAVAMI ČLANICAMI, KOORDINACIJSKA SKUPINA ZA MEDICINSKE PRIPOMOČKE, REFERENČNI LABORATORIJI EU IN REGISTRI PRIPOMOČKOV
The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with Article 51 for the device concerned and be accessible to the Member States and to the Commission.
Člen 96
Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States.
Pristojni organi
CHAPTER VIII
Države članice imenujejo pristojni organ ali organe, odgovorne za izvajanje te uredbe.
COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS
Zagotovijo jim pooblastila, sredstva, opremo in znanje, ki so potrebni za pravilno izvedbo njihov nalog v skladu s to uredbo.
Article 96
Države članice Komisiji sporočijo nazive in kontaktne podatke pristojnih organov, ki objavi seznam pristojnih organov.
Competent authorities
Člen 97
The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation.
Sodelovanje
They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation.
Pristojni organi držav članic sodelujejo med seboj in s Komisijo.
The Member States shall communicate the names and contact details of the competent authorities to the Commission which shall publish a list of competent authorities.
Komisija organizira izmenjavo informacij, potrebnih za enotno uporabo te uredbe.
Article 97
Države članice ob podpori Komisije po potrebi sodelujejo v mednarodnih pobudah, da se zagotovi sodelovanje med regulativnimi organi na področju medicinskih pripomočkov.
Cooperation
Člen 98
The competent authorities of the Member States shall cooperate with each other and with the Commission.
Koordinacijska skupina za medicinske pripomočke
The Commission shall provide for the organisation of exchanges of information necessary to enable this Regulation to be applied uniformly.
Koordinacijska skupina za medicinske pripomočke, ustanovljena v skladu s pogoji in podrobnimi ureditvami iz člena 103 in 107 Uredbe (EU) 2017/745, ob podpori Komisije, kot je določeno v členu 104 Uredbe (EU) 2017/745, opravlja naloge, ki so ji dodeljene na podlagi te uredbe in na podlagi Uredbe (EU) 2017/745.
Member States shall with the support of the Commission participate, where appropriate, in initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical devices.
Člen 99
Article 98
Naloge Koordinacijske skupine za medicinske pripomočke
Medical Device Coordination Group
Koordinacijska skupina za medicinske pripomočke v skladu s to uredbo opravlja naslednje naloge:
The Medical Device Coordination Group (MDCG) established in accordance with the conditions and detailed arrangements referred to in Article 103 and 107 of Regulation (EU) 2017/745 shall carry out, with the support of the Commission as provided in Article 104 of Regulation (EU) 2017/745, the tasks conferred on it under this Regulation as well as those under Regulation (EU) 2017/745.
sodeluje pri oceni ustreznosti organov za ugotavljanje skladnosti, ki so vložili vlogo, in priglašenih organov v skladu z določbami, določenimi v poglavju IV;
Article 99
svetuje Komisiji na njeno zahtevo v zvezi z zadevami, povezanimi s koordinacijsko skupino priglašenih organov, ustanovljene na podlagi člena 45;
Tasks of the MDCG
sodeluje pri razvoju smernic, katerih cilj je zagotoviti učinkovito in usklajeno izvajanje te uredbe, zlasti glede imenovanja in spremljanja priglašenih organov, izpolnjevanja splošnih zahtev glede varnosti in učinkovitosti ter izvedbe ocen učinkovitosti s strani proizvajalcev, ocene s strani priglašenih organov in dejavnosti vigilance;
Under this Regulation, the MDCG shall have the following tasks:
sodeluje pri stalnem spremljanju tehničnega napredka in presoji, ali so splošne zahteve glede varnosti in učinkovitosti, ki jih določata ta uredba in Uredba (EU) 2017/745, ustrezne za zagotovitev varnosti in učinkovitosti pripomočkov, ter tako prispeva k ugotavljanju, ali obstaja potreba po spremembi Priloge I k tej uredbi;
to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV;
sodeluje pri razvoju standardov za pripomočke in skupnih specifikacij;
to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 45;
pomaga pristojnim organom držav članic pri njihovih dejavnostih usklajevanja, zlasti na področju razvrstitve in določitve regulativnega statusa pripomočkov, študij učinkovitosti, vigilance in nadzora trga, vključno z razvojem in vzdrževanjem okvira za evropski program za nadzor trga, katerega cilj je zagotoviti učinkovitost in usklajevanje nadzora trga v Uniji v skladu s členom 88;
to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of performance evaluations by manufacturers, assessment by notified bodies and vigilance activities;
svetuje, bodisi na lastno pobudo ali na zahtevo Komisije, pri oceni katerega koli vprašanja, povezanega z izvajanjem te uredbe;
to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and performance requirements laid down in this Regulation and Regulation (EU) 2017/745 are adequate to ensure safety and performance of devices, and thereby contribute to identifying whether there is a need to amend Annex I to this Regulation;
sodeluje pri usklajevanju upravne prakse glede pripomočkov v državah članicah.
to contribute to the development of device standards and of CS;
Člen 100
to assist the competent authorities of the Member States in their coordination activities in particular in the fields of classification and the determination of the regulatory status of devices, performance studies, vigilance and market surveillance including the development and maintenance of a framework for a European market surveillance programme with the objective of achieving efficiency and harmonisation of market surveillance in the Union, in accordance with Article 88;
Referenčni laboratoriji Evropske unije
to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue related to the implementation of this Regulation;
Za posebne pripomočke oziroma kategorije ali skupine pripomočkov ali za posebne nevarnosti, povezane s kategorijo ali skupino pripomočkov, lahko Komisija z izvedbenimi akti imenuje enega ali več referenčnih laboratorijev Evropske unije (v nadaljnjem besedilu: referenčni laboratoriji EU), ki izpolnjujejo merila, določena v odstavku 4.
to contribute to harmonised administrative practice with regard to devices in the Member States.
Komisija imenuje samo tiste referenčne laboratorije EU, za katere sta država članica ali Skupno raziskovalno središče Komisije predložila vlogo za imenovanje.
Article 100
Kadar je to primerno, so naloge referenčnih laboratorijev EU na področju, za katerega so imenovani, naslednje:
The European Union reference laboratories
preverjanje učinkovitosti, ki jo navaja proizvajalec, in skladnosti pripomočkov razreda D z veljavnimi skupnimi specifikacijami, kadar so na voljo, ali drugimi rešitvami, ki jih proizvajalec izbere za zagotovitev vsaj enakovredne ravni varnosti in učinkovitosti, kot je določeno v tretjem pododstavku člena 48(3);
For specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices, the Commission may designate, by means of implementing acts, one or more European Union reference laboratories (the ‘EU reference laboratories’), that satisfy the criteria set out in paragraph 4.
ustrezno testiranje vzorcev izdelanih pripomočkov razreda D ali serij pripomočkov razreda D, kot je določeno v oddelku 4.12 Priloge IX in oddelku 5.1 Priloge XI;
The Commission shall only designate the EU reference laboratories for which a Member State or the Commission's Joint Research Centre have submitted an application for designation.
zagotovitev znanstvene in tehnične pomoči Komisiji, Koordinacijski skupini za medicinske pripomočke, državam članicam in priglašenim organom v zvezi z izvajanjem te uredbe;
Within the scope of their designation, the EU reference laboratories shall, where appropriate, have the following tasks:
zagotovitev znanstvenega svetovanja o zadnjem stanju tehničnega razvoja na področju posebnih pripomočkov oziroma posebne kategorije ali skupine pripomočkov;