natgillin/translations-raw huggingface dataset:
In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
Če organ, pristojen za priglašene organe, ugotovi, da priglašeni organ ne more prevzeti odgovornosti za veljavne izdane certifikate, proizvajalec pristojnemu organu za in vitro diagnostične medicinske pripomočke v državi članici, v kateri ima registrirani kraj poslovanja proizvajalec pripomočka, na katerega se nanaša certifikat, v treh mesecih od začasnega preklica ali omejitve predloži pisno potrditev, da je drug kvalificiran priglašeni organ začasno prevzel naloge priglašenega organa za spremljanje in da med obdobjem začasnega preklica ali omejitve ostaja odgovoren za certifikate.
With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances:
Razen neupravičeno izdanih certifikatov in kadar je bilo imenovanje preklicano, ostanejo certifikati v naslednjih okoliščinah veljavni še devet mesecev:
where the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and
kadar je pristojni organ za in vitro diagnostične medicinske pripomočke države članice, v kateri ima registrirani kraj poslovanja proizvajalec pripomočka, ki ga certifikat zajema, potrdil, da glede zadevnih pripomočkov ni varnostnih zadržkov, in
another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation.
kadar je drugi priglašeni organ pisno potrdil, da bo takoj prevzel odgovornost za te pripomočke, v dvanajstih mesecih od preklica imenovanja pa zaključil oceno pripomočkov.
In the circumstances referred to in the first subparagraph, the national competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months.
V okoliščinah iz prvega pododstavka sme nacionalni pristojni organ za in vitro diagnostične medicinske pripomočke v državi članici, v kateri ima registrirani kraj poslovanja proizvajalec pripomočka, na katerega se nanaša certifikat, podaljšati začasno veljavnost certifikatov še za tri mesece, pri čemer v celoti ne sme presegati dvanajst mesecev.
The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
Organ ali priglašeni organ, ki je prevzel naloge priglašenega organa, na katerega vpliva sprememba imenovanja, o tem takoj obvesti Komisijo, druge države članice in druge priglašene organe.
The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in Annex VII or the obligations to which they are subject.
Komisija v sodelovanju s Koordinacijsko skupino za medicinske pripomočke preišče vse primere, pri katerih je bila opozorjena, da priglašeni organ ali eden ali več njegovih odvisnih družb ali podizvajalcev ne izpolnjuje stalno obveznosti, določenih v Prilogi VII, ki veljajo zanj.
It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns.
Poskrbeti mora za to, da je zadevni organ, pristojen za priglašene organe, o tem obveščen in da ima možnost za preiskavo teh opozoril.
The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned.
Država članica priglasiteljica Komisiji na zahtevo predloži vse informacije v zvezi z imenovanjem zadevnega priglašenega organa.
The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described in Article 35(3) and (5) where there is reasonable concern about the ongoing compliance of a notified body or a subsidiary or subcontractor of the notified body with the requirements set out in Annex VII and where the investigation by the authority responsible for notified bodies is not deemed to have fully addressed the concerns or upon request of the authority responsible for notified bodies.
Komisija lahko v sodelovanju s Koordinacijsko skupino za medicinske pripomočke, kot je ustrezno, začne postopek ocenjevanja, opisan v členu 35(3) in (5), če obstaja utemeljen dvom, da priglašeni organ oziroma odvisna družba ali podizvajalec priglašenega organa ne izpolnjuje stalno zahtev, določenih v Prilogi VII, in če se šteje, da preiskava organa, pristojnega za priglašene organe, ni povsem odpravila dvomov, ali na zahtevo organa, pristojnega za priglašene organe.
The reporting and outcome of that assessment shall follow the principles of Article 35.
Poročanje in rezultati tega ocenjevanja so v skladu z načeli iz člena 35.
Alternatively, depending on the severity of the issue, the Commission, in conjunction with the MDCG, may request that the authority responsible for notified bodies allow the participation of up to two experts from the list established pursuant to Article 36 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 40 and as outlined in the annual assessment plan described in Article 40(4) therein.
Glede na resnost vprašanja lahko Komisija v sodelovanju s Koordinacijsko skupino za medicinske pripomočke namesto tega od organa, pristojnega za priglašene organe, zahteva, naj omogoči udeležbo največ dveh strokovnjakov s seznama, sestavljenega na podlagi člena 36, pri ocenjevanju na kraju samem, ki je del načrtovanih dejavnosti spremljanja in ocenjevanja v skladu s členom 40 ter je predvideno v letnem načrtu ocenjevanj iz člena 40(4).
Where the Commission ascertains that a notified body no longer meets the requirements for its designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the designation if necessary.
Kadar Komisija ugotovi, da priglašeni organ ne izpolnjuje več zahtev za imenovanje, o tem obvesti državo članico priglasiteljico in od nje zahteva, da sprejme potrebne korektivne ukrepe, po potrebi vključno z začasnim preklicem, omejitvijo ali preklicem imenovanja.
Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the designation.
Če država članica ne sprejme potrebnih korektivnih ukrepov, lahko Komisija z izvedbenimi akti začasno prekliče, omeji ali prekliče imenovanje.
It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 52.
Komisija zadevno državo članico uradno obvesti o svoji odločitvi ter posodobi NANDO in elektronski sistem iz člena 52.
The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly.
Komisija zagotovi, da se vse zaupne informacije, pridobljene v okviru njenih preiskav, obravnavajo temu ustrezno.
Peer review and exchange of experience between authorities responsible for notified bodies
Medsebojni strokovni pregled in izmenjava izkušenj med organi, pristojnimi za priglašene organe
The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies.
Komisija poskrbi za organizacijo izmenjave izkušenj in usklajevanje upravnih praks med organi, pristojnimi za priglašene organe.
Such exchange shall cover elements including:
Ta izmenjava vključuje naslednje elemente:
development of best practice documents relating to the activities of the authorities responsible for notified bodies;
pripravo dokumentov o najboljših praksah glede dejavnosti organov, pristojnih za priglašene organe;
development of guidance documents for notified bodies in relation to the implementation of this Regulation;
oblikovanje smernic za priglašene organe v zvezi z izvajanjem te uredbe;
training and qualification of the experts referred to in Article 36;
usposabljanje in izobraževanje strokovnjakov iz člena 36;
monitoring of trends relating to changes to notified body designations and notifications, and trends in certificate withdrawals and transfers between notified bodies;
spremljanje trendov pri spremembah imenovanj in priglasitev priglašenega organa ter pri preklicih certifikatov in zamenjavah med priglašenimi organi;
monitoring of the application and applicability of scope codes referred to in Article 38(13);
spremljanje uporabe in uporabnosti kod za opredelitev področja uporabe iz člena 38(13);
development of a mechanism for peer reviews between authorities and the Commission;
razvoj mehanizma za medsebojne strokovne preglede med organi in Komisijo;
methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.
načine obveščanja javnosti o dejavnostih organov in Komisije za spremljanje in nadzor priglašenih organov.
The authorities responsible for notified bodies shall participate in a peer review every third year through the mechanism developed pursuant to paragraph 1 of this Article.
Organi, pristojni za priglašene organe, vsako tretje leto prek mehanizma, razvitega na podlagi odstavka 1 tega člena, sodelujejo pri medsebojnem strokovnem pregledu.
Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 35.
Ti pregledi se običajno izvedejo vzporedno z ocenami na kraju samem, opisanimi v členu 35.
Alternatively, a national authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 40.
Nacionalni organ pa se lahko odloči tudi, da se bodo takšni pregledi izvajali v okviru njegovih dejavnosti spremljanja iz člena 40.
The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism.
Komisija sodeluje pri organizaciji in zagotavlja podporo pri izvajanju mehanizma za medsebojni strokovni pregled.
The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available.
Komisija sestavi letno zbirno poročilo o dejavnostih medsebojnega strokovnega pregleda, ki ga javno objavi.
The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanisms and training and qualification as referred to in paragraph 1 of this Article.
Komisija lahko z izvedbenimi akti sprejme ukrepe, v katerih določi podrobno ureditev in pripadajoče dokumente za mehanizme medsebojnega strokovnega pregleda ter usposabljanje in izobraževanje iz odstavka 1 tega člena.
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies, as referred to in Article 49 of Regulation (EU) 2017/745.
Komisija zagotovi, da je ustrezna koordinacija in sodelovanje med priglašenimi organi vzpostavljeno in deluje kot koordinacijska skupina priglašenih organov iz člena 49 Uredbe (EU) 2017/745.
The bodies notified under this Regulation shall participate in the work of that group.
Organi, priglašeni v okviru te uredbe, sodelujejo pri delu navedene skupine.
List of standard fees
Seznam standardnih pristojbin
Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.
Priglašeni organi sestavijo sezname svojih standardnih pristojbin za dejavnosti ugotavljanja skladnosti, ki jih izvajajo, in te sezname javno objavijo.
CLASSIFICATION AND CONFORMITY ASSESSMENT
RAZVRSTITEV IN UGOTAVLJANJE SKLADNOSTI
Classification of devices
Razvrstitev pripomočkov
Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks.
Pripomočki se razvrstijo v razrede A, B, C in D, pri čemer se upošteva predvideni namen pripomočkov in z njim povezana tveganja.
Classification shall be carried out in accordance with Annex VIII.
Razvrstitev se opravi v skladu s Prilogo VIII.
Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business.
O vsakem sporu med proizvajalcem in zadevnim priglašenim organom, ki izhaja iz uporabe Priloge VIII, odloča pristojni organ v državi članici, v kateri ima proizvajalec registrirani kraj poslovanja.
In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2. of Annex IX has its registered place of business.
Če proizvajalec nima registriranega kraja poslovanja v Uniji in še ni imenoval pooblaščenega predstavnika, se zadeva preda pristojnemu organu v državi članici, v kateri ima registrirani kraj poslovanja pooblaščeni predstavnik iz zadnje alineje točke (b) drugega odstavka oddelka 2.2.
Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body.
Priloge IX.
The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision.
Če ima zadevni priglašeni organ sedež v drugi državi članici kot proizvajalec, pristojni organ sprejme odločitev po posvetovanju s pristojnim organom države članice, ki je imenovala priglašeni organ.
The decision shall be made available upon request.
Pristojni organ v državi članici, v kateri ima registrirani kraj poslovanja proizvajalec, uradno obvesti Koordinacijsko skupino za medicinske pripomočke in Komisijo o svoji odločitvi.
At the request of a Member State, the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following:
Vpogled v odločitev je mogoč na zahtevo.
application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices;
Komisija na zahtevo države članice po posvetovanju s Koordinacijsko skupino za medicinske pripomočke z izvedbenimi akti odloči o naslednjem:
that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII.
o uporabi Priloge VIII, za določen pripomoček oziroma kategorijo ali skupino pripomočkov, da bi določili razvrstitev teh pripomočkov;
The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3.
da se pripomoček oziroma kategorija ali skupina pripomočkov zaradi javnega zdravja ponovno razvrsti na podlagi novih znanstvenih dokazov ali informacij, ki se pojavijo med vigilanco in dejavnostmi nadzora trga, z odstopanjem od Priloge VIII.
In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
Komisija lahko na lastno pobudo in po posvetovanju s Koordinacijsko skupino za medicinske pripomočke z izvedbenimi akti odloči o vprašanjih iz točk (a) in (b) odstavka 3.
The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Da se zagotovi enotna uporaba Priloge VIII, in upoštevajo ustrezna znanstvena mnenja ustreznih znanstvenih odborov, lahko Komisija sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe.
Conformity assessment
Izvedbeni akti iz odstavkov 3, 4 in 5 tega člena se sprejmejo v skladu s postopkom pregleda iz člena 107(3).
Article 48
Ugotavljanje skladnosti
Conformity assessment procedures
Člen 48
Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
Postopki ugotavljanja skladnosti
Prior to putting into service a device that is not placed on the market, with the exception of in-house devices manufactured pursuant to Article 5(5), manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
Proizvajalci pred dajanjem pripomočka na trg ocenijo njegovo skladnost z veljavnimi postopki za ugotavljanje skladnosti, opredeljenimi v prilogah IX do XI.
Manufacturers of class D devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I, II except for Section 5, and in Chapter III of Annex IX.
Proizvajalci preden dajo v uporabo pripomoček, ki ni dan na trg, razen internih pripomočkov, izdelanih v skladu s členom 5(5),ocenijo skladnost tega pripomočka v skladu z veljavnimi postopki za ugotavljanje skladnosti, opredeljenimi v prilogah IX do XI.
In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX.
Pri proizvajalcih pripomočkov razreda D, razen pripomočkov za študijo učinkovitosti, se opravi ugotavljanje skladnosti, kot je določeno v poglavjih I in II (razen oddelka 5) ter v poglavju III Priloge IX.
In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council [25] or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.
Pri pripomočkih za samotestiranje in testiranje ob pacientu proizvajalec poleg postopkov iz prvega pododstavka opravi tudi postopek za oceno tehnične dokumentacije iz oddelka 5.1 Priloge IX.
Manufacturers of class D devices, other than devices for performance study, may, instead of the conformity assessment procedure applicable pursuant to paragraph 3, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.
Poleg postopkov iz prvega in drugega pododstavka za pripomočke za dopolnilno diagnostiko se priglašeni organ posvetuje s pristojnim organom, imenovanim s strani države članice v skladu z Direktivo 2001/83/ES Evropskega parlamenta in Sveta [25], ali z EMA, kot je ustrezno, v skladu s postopki, določenimi v oddelku 5.2 Priloge IX.
For companion diagnostics, the notified body shall in particular consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
Proizvajalci pripomočkov razreda D, razen pripomočkov za študijo učinkovitosti, lahko namesto postopka ugotavljanja skladnosti, ki se uporablja na podlagi odstavka 3, odločijo za ugotavljanje skladnosti, kot je določeno v Prilogi X, v kombinaciji z ugotavljanjem skladnosti, kot je določeno v Prilogi XI.
The relevant experts shall, under the supervision of the Commission, provide their views, in accordance with Section 4.9 of Annex IX or point (j) of Section 3 of Annex X, as applicable, to the notified body within the deadline for delivery of the scientific opinion by the EU reference laboratory as specified therein.
7.
Manufacturers of class C devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex of at least one representative device per generic device group.
Pri proizvajalcih pripomočkov razreda C, razen pripomočkov za študijo učinkovitosti, se izvede ugotavljanje skladnosti, kot je določeno v poglavjih I in III Priloge IX, vključno z oceno tehnične dokumentacije, kot je določeno v oddelkih 4.4 do 4.8 navedene priloge, in sicer najmanj enega reprezentativnega pripomočka na vsako generično skupino pripomočkov.
In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX.
Pri pripomočkih za samotestiranje in testiranje ob pacientu proizvajalec poleg postopkov iz prvega pododstavka izvede tudi postopek za oceno tehnične dokumentacije iz oddelka 5.1 Priloge IX.
In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.
Za pripomočke za dopolnilno diagnostiko priglašeni organ poleg postopkov iz prvega in drugega pododstavka za vsak pripomoček izvede tudi postopek za oceno tehnične dokumentacije, določen v oddelku 5.2 Priloge IX, ter uporabi postopek za oceno tehnične dokumentacije, določen v oddelkih 4.1 do 4.8 Priloge IX, ter se posvetuje s pristojnim organom, ki ga imenujejo države članice v skladu z Direktivo 2001/83/ES ali z EMA, kot je ustrezno, in sicer v skladu s postopkom, določenim v oddelku 5.2 Priloge IX.
Manufacturers of class C devices, other than devices for performance study, may, instead of the conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5.
Proizvajalci pripomočkov razreda C, razen pripomočkov za študijo učinkovitosti, se lahko namesto postopka ugotavljanja skladnosti v skladu z odstavkom 7 odločijo za ugotavljanje skladnosti, kot je določeno v Prilogi X, v kombinaciji z ugotavljanjem skladnosti, kot je določeno v Prilogi XI, razen njenega oddelka 5.