natgillin/translations-raw huggingface dataset:
The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices.
Organ, pristojen za priglašene organe, o vsakem začasnem preklicu, omejitvi ali preklicu imenovanja takoj obvesti Komisijo in druge države članice.
Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation.
Če se imenovanje priglašenega organa začasno prekliče, omeji oziroma v celoti ali delno prekliče, priglašeni organ o tem najpozneje v 10 dneh obvesti zadevne proizvajalce.
Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.
Organ, pristojen za priglašene organe, v primeru omejitve, začasnega preklica ali preklica imenovanja sprejme ustrezne ukrepe, da so dokumenti zadevnega priglašenega organa shranjeni, in jih da na voljo organom, pristojnim za priglašene organe, v drugih državah članicah ter organom, pristojnim za nadzor trga, če to zahtevajo.
A suspension shall not exceed a period of one year, renewable once for the same period.
V primeru omejitve, začasnega preklica ali preklica imenovanja organ, pristojen za priglašene organe:
The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation.
oceni vpliv na certifikate, ki jih je izdal priglašeni organ;
Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days.
Komisiji in drugim državam članicam v treh mesecih od uradnega obvestila o spremembah imenovanja predloži poročilo o svojih ugotovitvah;
In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request.
zahteva, da v razumnem času, ki ga določi priglašeni organ, začasno ali trajno prekliče vse neupravičeno izdane certifikate, da se zagotovi varnost pripomočkov na trgu;
In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall:
v elektronski sistem iz člena 57 vnese informacije za certifikate, za katere je zahteval začasni ali trajni preklic;
assess the impact on the certificates issued by the notified body;
pristojni organ za medicinske pripomočke države članice, v kateri ima proizvajalec teh pripomočkov registrirani kraj poslovanja, prek elektronskega sistema iz člena 57 obvesti o certifikatih, za katere je zahteval začasni ali trajni preklic.
submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
Pristojni organ po potrebi sprejme ustrezne ukrepe za preprečitev morebitnega tveganja za zdravje ali varnost pacientov, uporabnikov ali drugih oseb.
require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market;
Kadar je bilo imenovanje začasno preklicano ali omejeno, ostanejo certifikati, razen neupravičeno izdanih, veljavni v naslednjih okoliščinah:
enter into the electronic system referred to in Article 57 information in relation to certificates of which it has required their suspension or withdrawal;
organ, pristojen za priglašene organe, je potrdil v enem mesecu od začasnega preklica ali omejitve, da v zvezi s certifikati, za katere velja začasni preklic ali omejitev, ni nobenega varnostnega tveganja, in določil časovni potek in ukrepe, ki naj bi bili potrebni za odpravo začasnega preklica ali omejitve; ali
inform the competent authority for medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 57 of the certificates for which it has required suspension or withdrawal.
organ, pristojen za priglašene organe, je potrdil, da v času začasnega preklica ali omejitve ne bo izdan, spremenjen ali ponovno izdan noben certifikat, povezan z začasnim preklicem, poleg tega pa navede, ali je priglašeni organ v času začasnega preklica ali omejitve še vedno sposoben spremljati in ostati pristojen za veljavne izdane certifikate.
That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others.
Če organ, pristojen za priglašene organe, ugotovi, da priglašeni organ ne more prevzeti odgovornosti za veljavne izdane certifikate, proizvajalec pripomočka, na katerega se certifikat nanaša, pristojnemu organu za medicinske pripomočke v državi članici, v kateri ima ta proizvajalec registrirani kraj poslovanja, v treh mesecih od začasnega preklica ali omejitve predloži pisno potrditev, da je drug kvalificirani priglašeni organ začasno prevzel naloge priglašenega organa za spremljanje in da v času začasnega preklica ali omejitve ostaja ta odgovoren za certifikate.
With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances:
Kadar je bilo imenovanje preklicano, ostanejo certifikati, razen neupravičeno izdanih, v naslednjih okoliščinah veljavni še devet mesecev:
the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or
kadar je pristojni organ za medicinske pripomočke države članice, v kateri ima registrirani kraj poslovanja proizvajalec pripomočka, na katerega se certifikat nanaša, potrdil, da glede zadevnih pripomočkov ni varnostnih zadržkov, in
the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction.
drug priglašeni organ je pisno potrdil, da bo takoj prevzel odgovornost za te pripomočke in v dvanajstih mesecih od preklica imenovanja zaključil oceno pripomočkov.
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 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.
V okoliščinah iz prvega pododstavka sme pristojni organ za medicinske pripomočke v državi članici, v kateri ima registrirani kraj poslovanja proizvajalec pripomočka, na katerega se certifikat nanaša, podaljšati začasno veljavnost certifikatov še za tri mesece, pri čemer začasna veljavnost v celoti ne sme preseči dvanajst mesecev.
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:
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.
where the competent authority for 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
Člen 47
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.
Izpodbijanje usposobljenosti priglašenih organov
In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months.
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 VI, ali obveznosti, ki veljajo zanj.
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.
Poskrbeti mora, da je zadevni organ, pristojen za priglašene organe, o tem obveščen in da ima možnost za preiskavo teh opozoril.
Article 47
Država članica priglasiteljica Komisiji na zahtevo predloži vse informacije v zvezi z imenovanjem zadevnega priglašenega organa.
Challenge to the competence of notified bodies
Komisija lahko v sodelovanju s Koordinacijsko skupino za medicinske pripomočke, kot je ustrezno, začne postopek ocenjevanja, opisan v členu 39(3) in (4), kadar obstaja utemeljen dvom, da priglašeni organ ali njegova odvisna družba ali podizvajalec ne izpolnjuje stalno zahtev, določenih v Prilogi VII, in kadar se šteje, da preiskava organa, pristojnega za priglašene organe, ni povsem odpravila dvomov, ali na zahtevo organa, pristojnega za 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.
Poročanje in rezultati tega ocenjevanja so v skladu z načeli iz člena 39.
It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns.
Glede na resnost zadeve 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 40, pri ocenjevanju na kraju samem, ki je del načrtovanih dejavnosti spremljanja in ocenjevanja v skladu s členom 44 ter je predvideno v letnem načrtu ocenjevanj iz člena 44(4).
The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned.
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.
The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described in Article 39(3) and (4), 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.
Če država članica ne sprejme potrebnih korektivnih ukrepov, lahko Komisija z izvedbenimi akti začasno prekliče, omeji ali prekliče imenovanje.
The reporting and outcome of that assessment shall follow the principles of Article 39.
Komisija zadevno državo članico uradno obvesti o svoji odločitvi ter posodobi NANDO in elektronski sistem iz člena 57.
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 40 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 44 and as outlined in the annual assessment plan described in Article 44(4).
Komisija zagotovi, da se vse zaupne informacije, pridobljene v okviru njenih preiskav, obravnavajo temu primerno.
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.
Člen 48
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.
Medsebojni strokovni pregled in izmenjava izkušenj med organi, pristojnimi za priglašene organe
It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 57.
Komisija poskrbi za organizacijo izmenjave izkušenj in usklajevanje upravnih praks med organi, pristojnimi za priglašene organe.
The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly.
Takšna izmenjava vključuje naslednje elemente:
Article 48
pripravo dokumentov o najboljših praksah glede dejavnosti organov, pristojnih za priglašene organe;
Peer review and exchange of experience between authorities responsible for notified bodies
oblikovanje smernic za priglašene organe v zvezi z izvajanjem te uredbe;
The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies.
usposabljanje in izobraževanje strokovnjakov iz člena 40;
Such exchange shall cover elements including:
spremljanje trendov pri spremembah imenovanj in priglasitev priglašenega organa ter pri preklicih certifikatov in zamenjavah med priglašenimi organi;
development of best practice documents relating to the activities of the authorities responsible for notified bodies;
spremljanje uporabe in uporabnosti kod za opredelitev področja uporabe iz člena 42(13);
development of guidance documents for notified bodies in relation to the implementation of this Regulation;
razvoj mehanizma za medsebojne strokovne preglede med organi in Komisijo;
training and qualification of the experts referred to in Article 40;
načine obveščanja javnosti o dejavnostih organov in Komisije za spremljanje in nadzor priglašenih organov.
monitoring of trends relating to changes to notified body designations and notifications and trends in certificate withdrawals and transfers between notified bodies;
Organi, pristojni za priglašene organe, vsako tretje leto prek mehanizma, razvitega na podlagi odstavka 1 tega člena, sodelujejo pri medsebojnem strokovnem pregledu.
monitoring of the application and applicability of scope codes referred to in Article 42(13);
Ti pregledi se običajno izvedejo vzporedno s skupnim ocenjevanjem na kraju samem, opisanim v členu 39.
development of a mechanism for peer reviews between authorities and the Commission;
Organ pa se lahko odloči tudi, da se bodo takšni pregledi izvajali v okviru njegovih dejavnosti spremljanja iz člena 44.
methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.
Komisija sodeluje pri organizaciji in zagotavlja podporo pri izvajanju mehanizma za medsebojni strokovni pregled.
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.
Komisija sestavi letno zbirno poročilo o dejavnostih medsebojnega strokovnega pregleda, ki ga javno objavi.
Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 39.
Komisija lahko z izvedbenimi akti sprejme ukrepe, v katerih določi podrobno ureditev in pripadajoče dokumente glede mehanizma za medsebojni strokovni pregled ter usposabljanja in izobraževanja iz odstavka 1 tega člena.
Alternatively, an authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 44.
Člen 49
The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism.
Usklajevanje priglašenih organov
The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available.
Komisija zagotovi, da je ustrezno usklajevanje in sodelovanje med priglašenimi organi vzpostavljeno in deluje kot koordinacijska skupina priglašenih organov na področju medicinskih pripomočkov, vključno z in vitro diagnostičnimi medicinskimi pripomočki.
The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanism and training and qualification as referred to in paragraph 1 of this Article.
Ta skupina se sestaja redno in vsaj vsako leto.
Article 49
Organi, priglašeni v okviru te uredbe, sodelujejo pri delu navedene skupine.
Coordination of notified bodies
Komisija lahko določi posebno ureditev za delovanje koordinacijske skupine priglašenih organov.
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices.
Člen 50
This group shall meet on a regular basis and at least annually.
Seznam standardnih pristojbin
The bodies notified under this Regulation shall participate in the work of that group.
Priglašeni organi sestavijo sezname svojih standardnih pristojbin za dejavnosti ugotavljanja skladnosti, ki jih izvajajo, in te sezname javno objavijo.
The Commission may establish the specific arrangements for the functioning of the coordination group of notified bodies.
POGLAVJE V
Article 50
RAZVRSTITEV IN UGOTAVLJANJE SKLADNOSTI
List of standard fees
ODDELEK 1
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.
Razvrstitev
CHAPTER V
Člen 51
CLASSIFICATION AND CONFORMITY ASSESSMENT
Razvrstitev pripomočkov
SECTION 1
Pripomočki se razvrstijo v razrede I, IIa, IIb in III, pri čemer se upošteva predvideni namen pripomočkov in z njimi povezana tveganja.
Classification
Razvrstitev se opravi v skladu s Prilogo VIII.
Article 51
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.
Classification of devices
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 alinee točke (b) drugega odstavka oddelka 2.2 Priloge IX.
Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks.
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.
Classification shall be carried out in accordance with Annex VIII.
Pristojni organ v državi članici, v kateri ima proizvajalec registrirani kraj poslovanja, o svoji odločitvi uradno obvesti Koordinacijsko skupino za medicinske pripomočke in Komisijo.
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.
Vpogled v odločitev je mogoč na zahtevo.
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 je to upravičeno zaradi že uveljavljenih tehnologij, podobnih tehnologijam, uporabljenim v izvzetih pripomočkih s seznama v drugem pododstavku odstavka 4 tega člena, ki se uporabljajo v drugih pripomočkih za vsaditev razreda IIb, ali če je to upravičeno zaradi varovanja zdravja in varnosti pacientov, uporabnikov ali drugih oseb ali drugih vidikov javnega zdravja, se na Komisijo prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 115, s katerimi se navedeni seznam spremeni tako, da se nanj dodajo druge vrste pripomočkov za vsaditev razreda IIb ali se pripomočki z njega odstranijo.
4.
Če so pripomočki dani na trg v sterilnem stanju, če imajo merilno funkcijo ali če so kirurški instrumenti za ponovno uporabo, proizvajalec uporabi postopke iz poglavij I in III Priloge IX ali dela A Priloge XI.
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.
Vendar je vključitev priglašenega organa v te postopke omejena:
5.
pri pripomočkih, danih na trg v sterilnem stanju, na vidike, ki so povezani z vzpostavljanjem pogojev za zagotavljanje in ohranjanje sterilnega stanja;
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.
pri pripomočkih z merilno funkcijo na vidike, ki so povezani s skladnostjo pripomočkov z metrološkimi zahtevami;
6.
v primeru kirurških instrumentov za ponovno uporabo na vidike, ki so povezani s ponovno uporabo pripomočka, zlasti čiščenje, razkuževanje, sterilizacijo, vzdrževanje in funkcionalno preskušanje ter navodila za uporabo.
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 114(3).
Proizvajalci pripomočkov, izdelanih za posameznega uporabnika, uporabijo postopek iz Priloge XIII in pred dajanjem takšnih pripomočkov na trg pripravijo izjavo iz oddelka 1 navedene priloge.
SECTION 2 Conformity assessment Article 52
Pri proizvajalcih pripomočkov za vsaditev razreda III, izdelanih za posameznega uporabnika, se poleg postopkov, ki se uporabljajo na podlagi prvega pododstavka, izvede ugotavljanje skladnosti, kot je določeno v poglavju I Priloge IX.
Conformity assessment procedures 1.
Proizvajalec se lahko namesto tega odloči, da uporabi ugotavljanje skladnosti, kot je določeno v delu A Priloge XI.