natgillin/translations-raw huggingface dataset:
The authorities responsible for notified bodies shall monitor the notified bodies established on their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its obligations set out in this Regulation.
Organi, pristojni za priglašene organe, spremljajo priglašene organe s sedežem na njihovem ozemlju ter njihove odvisne družbe in podizvajalce, da bi zagotovili stalno izpolnjevanje zahtev in njihovih obveznosti, določenih v tej uredbi.
Notified bodies shall, upon request by their authority responsible for notified bodies, supply all relevant information and documents, required to enable the authority, the Commission and other Member States to verify compliance.
Priglašeni organi na zahtevo svojega organa, pristojnega za priglašene organe, predložijo vse ustrezne informacije in dokumente, ki so potrebni, da organu, Komisiji in drugim državam članicam omogočijo preverjanje skladnosti.
Where the Commission or the authority of a Member State submits a request to a notified body established on the territory of another Member State relating to a conformity assessment carried out by that notified body, it shall send a copy of that request to the authority responsible for notified bodies of that other Member State.
Če Komisija ali organ države članice predloži priglašenemu organu s sedežem na ozemlju druge države članice zahtevo v zvezi z ugotavljanjem skladnosti, ki ga je opravil ta priglašeni organ, pošlje izvod te zahteve organu, pristojnemu za priglašene organe v zadevni drugi državi članici.
The notified body concerned shall respond without delay and within 15 days at the latest to the request.
Zadevni priglašeni organ odgovori na zahtevo nemudoma in najpozneje v 15 dneh.
The authority responsible for notified bodies of the Member State in which the body is established shall ensure that requests submitted by authorities of any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason for not doing so in which case the matter may be referred to the MDCG.
Organ, pristojen za priglašene organe države članice, v kateri ima organ sedež, zagotovi, da priglašeni organ razreši zahteve, ki so jih predložili organi katere koli druge države članice ali Komisija, razen če obstaja utemeljen razlog, da jih ne; v tem primeru se zadeva lahko pošlje Koordinacijski skupini za medicinske pripomočke.
At least once a year, the authorities responsible for notified bodies shall re-assess whether the notified bodies established on their respective territory and, where appropriate, the subsidiaries and subcontractors under the responsibility of those notified bodies still satisfy the requirements and fulfil their obligations set out in Annex VII.
Organi, pristojni za priglašene organe, vsaj enkrat na leto ponovno ocenijo, ali priglašeni organi s sedežem na njihovem ozemlju ter, kadar je to ustrezno, odvisne družbe in podizvajalci v pristojnosti teh priglašenih organov še vedno izpolnjujejo zahteve in obveznosti, določene v Prilogi VII.
That review shall include an on-site audit of each notified body and, where necessary, of its subsidiaries and subcontractors.
Ta pregled vključuje presojo na kraju samem pri vsakem priglašenem organu, po potrebi pa tudi pri odvisnih družbah in podizvajalcih.
The authority responsible for notified bodies shall conduct its monitoring and assessment activities according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the notified body with the requirements of this Regulation.
Organ, pristojen za priglašene organe, izvaja dejavnosti spremljanja in ocenjevanja v skladu z letnim načrtom ocenjevanja, da bi lahko učinkovito spremljal, ali priglašeni organ stalno izpolnjuje zahteve iz te uredbe.
That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular, associated subsidiaries and subcontractors.
V tem načrtu je naveden časovni razpored z obrazložitvijo pogostosti ocenjevanja priglašenega organa ter zlasti ustreznih odvisnih družb in podizvajalcev.
The authority shall submit its annual plan for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission.
Organ Koordinacijski skupini za medicinske pripomočke in Komisiji predloži letni načrt za spremljanje ali ocenjevanje za vsak priglašeni organ, za katerega je pristojen.
The monitoring of notified bodies by the authority responsible for notified bodies shall include observed audits of notified body personnel, including where necessary any personnel from subsidiaries and subcontractors, as that personnel in the process of conducting quality management system assessments at a manufacturer's facility.
Organ, pristojen za priglašene organe, v okviru spremljanja priglašenih organov pri postopku ocenjevanju sistema vodenja kakovosti, ki ga v prostorih proizvajalca izvaja osebje priglašenega organa oziroma osebje odvisnih družb in izvajalcev, izvede tudi presojo z opazovanjem tega osebja.
The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider data arising from market surveillance, vigilance and post-market surveillance to help guide its activities.
Organ, pristojen za priglašene organe, pri spremljanju priglašenih organov kot pomoč pri usmerjanju svojih dejavnosti upošteva podatke, pridobljene pri nadzoru trga, vigilanci in nadzoru po dajanju na trg.
The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and other information, including from other Member States, which may indicate non-fulfilment of the obligations by a notified body or its deviation from common or best practice.
Organ, pristojen za priglašene organe, skrbi za sistematično ukrepanje na podlagi pritožb in drugih informacij, tudi iz drugih držav članic, iz katerih je mogoče sklepati, da priglašeni organ ne izpolnjuje obveznosti ali pa da se oddaljuje od skupne ali najboljše prakse.
The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify compliance.
Organ, pristojen za priglašene organe, sme poleg rednega spremljanja ali ocen na kraju samem opravljati tudi preglede, napovedane na kratek rok, nenapovedane preglede ali namenske preglede, da bi razrešil posebno vprašanje ali preveril skladnost.
The authority responsible for notified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the performance evaluation documentation as further outlined in Article 41.
Organ, pristojen za priglašene organe, pregleda, kako so priglašeni organi ocenili proizvajalčevo tehnično dokumentacijo, zlasti dokumentacijo o oceni učinkovitosti iz člena 41.
The authority responsible for notified bodies shall document and record any findings regarding non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective and preventive actions.
Organ, pristojen za priglašene organe, dokumentira in zabeleži vse ugotovitve v zvezi z zahtevami, določenimi v Prilogi VII, ki jih priglašeni organ ni izpolnil, ter nato spremlja, ali so bili pravočasno izvedeni korektivni in preventivni ukrepi.
Three years after notification of a notified body, and again every fourth year thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team appointed for the purpose of the procedure described in Articles 34 and 35.
Organ, pristojen za priglašene organe države članice, v kateri ima organ sedež, in skupna ocenjevalna ekipa, imenovana za namen postopka iz členov 34 in 35, tri leta po priglasitvi priglašenega organa in nato vsako četrto leto ponovno celovito oceni, ali priglašeni organ še vedno izpolnjuje zahteve, določene v Prilogi VII.
The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to amend paragraph 10 of this Article to modify the frequency at which the complete re-assessment referred to in that paragraph is to be carried out.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 108 za spremembo odstavka 10 tega člena, tako da se spremeni pogostost izvajanja ponovnega celovitega ocenjevanja iz navedenega odstavka.
The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and subcontractors.
Države članice vsaj enkrat na leto poročajo Komisiji in Koordinacijski skupini za medicinske pripomočke o svojih dejavnostih spremljanja in ocenjevanja na kraju samem v zvezi s priglašenimi organi in po potrebi tudi v zvezi z odvisnimi družbami in podizvajalci.
The report shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however, it shall contain a summary which shall be made publicly available.
V poročilu navedejo podrobnosti o rezultatih teh dejavnosti, vključno z dejavnostmi na podlagi odstavka 7, in čeprav Koordinacijska skupina za medicinske pripomočke in Komisija to poročilo obravnavata kot zaupno, je v njem povzetek, ki je javno dostopen.
The summary of the report shall be uploaded to the electronic system referred to in Article 52.
Povzetek poročila se naloži v elektronski sistem iz člena 52.
Review of notified body assessment of technical documentation and performance evaluation documentation
Pregled ocene, ki jo v zvezi s tehnično dokumentacijo in dokumentacijo o oceni učinkovitosti opravi priglašeni organ
The authority responsible for notified bodies, as part of its ongoing monitoring of notified bodies, shall review an appropriate number of notified body assessments of manufacturers' technical documentation, in particular the performance evaluation documentation to verify the conclusions drawn by the notified body based on the information presented by the manufacturer.
Organ, pristojen za priglašene organe, v okviru stalnega spremljanja priglašenih organov pregleda ustrezno število ocen proizvajalčeve tehnične dokumentacije, in zlasti dokumentacije o oceni učinkovitosti, ki jih opravi priglašeni organ, da se preverijo ugotovitve, do katerih je prišel priglašeni organ na podlagi informacij proizvajalca.
The reviews by the authority responsible for notified bodies shall be conducted both off-site and on-site.
Organ, pristojen za priglašene organe, izvaja te preglede na kraju samem in drugod.
The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the types and risk of devices certified by the notified body, in particular high-risk devices, and be appropriately justified and documented in a sampling plan, which shall be made available by the authority responsible for notified bodies to the MDCG upon request.
Vzorčenje zadev, ki se pregledajo v skladu z odstavkom 1, je načrtovano in reprezentativno glede na vrste in tveganja pripomočkov, ki jih je certificiral priglašeni organ, zlasti pripomočkov z visokim tveganjem, ter je ustrezno utemeljeno in dokumentirano v načrtu vzorčenja, ki ga organ, pristojen za priglašene organe, da na voljo Koordinacijski skupini za medicinske pripomočke, če to zahteva.
The authority responsible for notified bodies shall review whether the assessment by the notified body was conducted appropriately and shall check the procedures used, associated documentation and the conclusions drawn by the notified body.
Organ, pristojen za priglašene organe, pregleda, ali je priglašeni organ ustrezno opravil oceno, ter preveri uporabljene postopke, pripadajočo dokumentacijo in ugotovitve priglašenega organa.
Such checking shall include the technical documentation and performance evaluation documentation of the manufacturer upon which the notified body has based its assessment.
To preverjanje vključuje tehnično dokumentacijo in dokumentacijo o oceni učinkovitosti proizvajalca, ki jih je priglašeni organ uporabil za svojo oceno.
Such reviews shall be conducted utilising CS.
Takšni pregledi se izvedejo z uporabo skupnih specifikacij.
Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 40(10) and the joint assessment activities referred to in Article 43(3).
Ti pregledi so tudi del ponovne ocene priglašenih organov v skladu s členom 40(10) in skupnih dejavnosti ocenjevanja iz člena 43(3).
The reviews shall be conducted utilising appropriate expertise.
Pregledi se izvedejo z uporabo ustreznega strokovnega znanja.
Based on the reports of the reviews and assessments by the authority responsible for notified bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market surveillance activities described in Chapter VII, or on the continuous monitoring of technical progress, or on the identification of concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that the sampling carried out under this Article cover a greater or lesser proportion of the technical documentation and performance evaluation documentation assessed by a notified body.
Koordinacijska skupina za medicinske pripomočke lahko na podlagi poročil organov, pristojnih za priglašene organe, ali skupnih ocenjevalnih ekip o pregledih in ocenah, na podlagi podatkov, pridobljenih med dejavnostmi nadzora trga, vigilance in nadzora po dajanju na trg, opisanih v poglavju VII, ali na podlagi stalnega spremljanja tehničnega napredka ali na podlagi opredelitve perečih in novih vprašanj, povezanih z varnostjo in učinkovitostjo pripomočkov, priporoči, da vzorčenje, opravljeno na podlagi tega člena, vključuje večji ali manjši delež tehnične dokumentacije in dokumentacije o oceni učinkovitosti, ki jih je ocenil priglašeni organ.
The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and performance evaluation documentation, as referred to in this Article.
Komisija lahko z izvedbenimi akti sprejme ukrepe, v katerih določi podrobne ureditve in spremne dokumente za pregled ocen tehnične dokumentacije in dokumentacije o oceni učinkovitosti v skladu s tem členom ter za njihovo usklajevanje.
Changes to designations and notifications
Spremembe imenovanj in priglasitev
The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body.
Organ, pristojen za priglašene organe, uradno obvesti Komisijo in druge države članice o vseh pomembnih spremembah v zvezi z imenovanjem priglašenega organa.
The procedures described in Article 35 and in Article 38 shall apply to extensions of the scope of the designation.
Postopki iz členov 35 in 38 se uporabljajo za razširitev področja uporabe imenovanja.
For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.
Za druge spremembe imenovanja, torej ne za razširitev njegovega področja uporabe, se uporabljajo postopki, opisani v naslednjih odstavkih.
The Commission shall immediately publish the amended notification in NANDO.
Komisija spremenjeno priglasitev nemudoma objavi v NANDO.
The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 52.
Komisija nemudoma vnese informacije o spremembi imenovanja priglašenega organa v elektronski sistem iz člena 52.
Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities.
Če priglašeni organ sklene, da bo prenehal dejavnosti za ugotavljanje skladnosti, o tem čim prej obvesti organ, pristojen za priglašene organe, in zadevne proizvajalce, v primeru načrtovanega prenehanja pa eno leto pred prenehanjem svojih dejavnosti.
The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates.
Certifikati lahko ostanejo začasno veljavni devet mesecev po prenehanju dejavnosti priglašenega organa, pod pogojem, da je drug priglašeni organ pisno potrdil, da bo prevzel odgovornost za pripomočke, na katere se ti certifikati nanašajo.
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.
Novi priglašeni organ opravi celotno oceno pripomočkov do konca tega obdobja, šele nato izda nove certifikate za te pripomočke.
Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation.
Če je priglašeni organ prenehal delovati, organ, pristojen za priglašene organe, imenovanje prekliče.
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.
Če organ, pristojen za priglašene organe, ugotovi, da priglašeni organ ne izpolnjuje več zahtev, določenih v Prilogi VII, ali da ne izpolnjuje svojih obveznosti ali da ni izvedel potrebnih korektivnih ukrepov, organ glede na resnost neizpolnjevanja navedenih zahtev ali nespoštovanja obveznosti začasno prekliče, omeji oziroma v celoti ali delno prekliče imenovanje.
A suspension shall not exceed a period of one year, renewable once for the same period.
Začasni preklic ne sme presegati obdobja enega leta, ki se lahko enkrat podaljša za enako obdobje.
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.
Organ, pristojen za priglašene organe, o vsakem začasnem preklicu, omejitvi ali preklicu imenovanja takoj obvesti Komisijo in druge države članice.
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.
Če se imenovanje priglašenega organa začasno prekliče, omeji ali v celoti ali delno prekliče, priglašeni organ o tem najpozneje v desetih dneh obvesti zadevne proizvajalce.
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.
Organ, pristojen za priglašene organe, v primeru omejitve, začasnega ali trajnega 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.
7 In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall:
V primeru omejitve, začasnega ali trajnega preklica imenovanja organ, pristojen za priglašene organe:
assess the impact on the certificates issued by the notified body;
oceni vpliv na certifikate, ki jih je izdal priglašeni organ;
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;
Komisiji in drugim državam članicam v treh mesecih od uradnega obvestila o spremembah imenovanja predloži poročilo o svojih ugotovitvah;
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;
od priglašenega organa zahteva, da v razumnem časovnem roku, ki ga določi nacionalni organ, začasno ali trajno prekliče vse neupravičeno izdane certifikate, da se zagotovi varnost pripomočkov na trgu;
enter in the electronic system referred to in Article 52 information in relation to certificates of which it has required their suspension or withdrawal;
v elektronski sistem iz člena 52 vnese informacije za certifikate, za katere je zahteval začasni ali trajni preklic;
inform the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 52 of the certificates for which it has required suspension or withdrawal.
pristojni organ za in vitro diagnostične medicinske pripomočke države članice, v kateri ima zadevni proizvajalec registrirani kraj poslovanja, prek elektronskega sistema iz člena 52 obvesti o certifikatih, za katere je zahteval začasni ali trajni preklic.
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.
Pristojni organ sprejme ustrezne ukrepe po potrebi za preprečitev morebitnega tveganja za zdravje ali varnost pacientov, uporabnikov ali drugih oseb.
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:
Razen neupravičeno izdanih certifikatov in kadar je bilo imenovanje začasno preklicano ali omejeno, ostanejo certifikati veljavni v naslednjih okoliščinah:
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
organ, pristojen za priglašene organe, je v enem mesecu od začasnega preklica ali omejitve potrdil, da v zvezi s certifikati, za katere velja začasni preklic ali omejitev, ni nobenega varnostnega tveganja, in organ, pristojen za priglašene organe, je določil časovni potek in ukrepe, ki naj bi bili potrebni za odpravo začasnega preklica ali omejitve; ali
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.
organ, pristojen za priglašene organe, je potrdil, da noben certifikat, povezan z začasnim preklicem, med začasnim preklicem ali omejitvijo ne bo izdan, spremenjen ali ponovno izdan, poleg tega pa navede, ali je priglašeni organ med obdobjem začasnega preklica ali omejitve še vedno sposoben spremljati in ostati odgovoren za veljavne izdane certifikate.