natgillin/translations-raw huggingface dataset:
When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph 6.
V njem se odzove na ugovore iz mnenja in navede razloge, zaradi katerih namerava imenovati organ za ugotavljanje skladnosti oziroma zakaj ga ne namerava imenovati.
After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter having been brought before it.
Če se država članica priglasiteljica odloči, da bo vztrajala pri svoji nameri o imenovanju organa za ugotavljanje skladnosti, potem ko je za to navedla razloge v skladu z odstavkom 8, Komisija v 14 dneh potem, ko je bila o tem obveščena, v NANDO objavi priglasitev.
Where the MDCG is of the opinion that the notification can be accepted, the Commission shall publish in NANDO the notification within 14 days.
Komisija pri objavi priglasitve v NANDO vnese v elektronski sistem iz člena 57 tudi informacije v zvezi s priglasitvijo priglašenega organa, dokumente iz odstavka 4 tega člena ter mnenje in odgovore iz odstavkov 7 in 8 tega člena.
Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40 days of its receipt.
Imenovanje začne veljati dan po tem, ko je priglasitev objavljena v NANDO.
The response shall address the objections raised in the opinion, and set out the reasons for the notifying Member State's decision to designate or not designate the conformity assessment body.
Objavljena priglasitev navaja obseg zakonite dejavnosti priglašenega organa v zvezi z ugotavljanjem skladnosti.
Where the notifying Member State decides to uphold its decision to designate the conformity assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notification within 14 days of being informed thereof.
Zadevni organ za ugotavljanje skladnosti lahko izvaja dejavnosti priglašenega organa šele potem, ko imenovanje postane veljavno v skladu z odstavkom 11.
When publishing the notification in NANDO, the Commission shall also add to the electronic system referred to in Article 57 the information relating to the notification of the notified body along with the documents mentioned in paragraph 4 of this Article and the opinion and responses referred to in paragraphs 7 and 8 of this Article.
Komisija do 26. novembra 2017 z izvedbenimi akti sestavi seznam kod in ustreznih vrst pripomočkov, da opredeli področje uporabe imenovanja priglašenih organov.
The designation shall become valid the day after the notification is published in NANDO.
Komisija lahko ta seznam po posvetovanju s Koordinacijsko skupino za medicinske pripomočke posodobi, med drugim tudi na podlagi informacij, pridobljenih pri usklajevalnih dejavnostih iz člena 48.
The published notification shall state the scope of lawful conformity assessment activity of the notified body.
Člen 43
The conformity assessment body concerned may perform the activities of a notified body only after the designation has become valid in accordance with paragraph 11.
Identifikacijska številka in seznam priglašenih organov
The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies.
Komisija dodeli identifikacijsko številko vsakemu priglašenemu organu, za katerega začne veljati priglasitev v skladu s členom 42(11).
The Commission, after consulting the MDCG, may update this list based, inter alia, on information arising from the coordination activities described in Article 48.
Dodeli mu enotno identifikacijsko številko, tudi če je organ priglašen v skladu z več akti Unije.
Article 43
Če so uspešno imenovani v skladu s to uredbo, organi, priglašeni v skladu z direktivama 90/385/EGS in 93/42/EGS, ohranijo identifikacijsko številko, ki jim je bila dodeljena v skladu z navedenima direktivama.
Identification number and list of notified bodies
Komisija v NANDO javnosti omogoči dostop do seznama organov, priglašenih v skladu s to uredbo, pa tudi do identifikacijskih številk, ki so jim bile dodeljene, in dejavnosti ugotavljanja skladnosti, kot so opredeljene v tej uredbi, ter vrst pripomočkov, za katere so bili priglašeni.
The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11).
Ta seznam da na voljo tudi prek elektronskega sistema iz člena 57.
It shall assign a single identification number even when the body is notified under several Union acts.
Komisija poskrbi za posodabljanje seznama.
If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them pursuant to those Directives.
Člen 44
The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO.
Spremljanje in ponovno ocenjevanje priglašenih organov
It shall also make this list available on the electronic system referred to in Article 57.
Priglašeni organi nemudoma in najpozneje v 15 dneh obvestijo organ, pristojen za priglašene organe, o pomembnih spremembah, ki bi lahko vplivale na njihovo izpolnjevanje zahtev, določenih v Prilogi VII, ali na njihovo zmožnost opravljanja dejavnosti ugotavljanja skladnosti, povezanih s pripomočki, za katere so bili imenovani.
The Commission shall ensure that the list is kept up to date.
Organi, pristojni za priglašene organe, spremljajo priglašene organe, ki imajo sedež na njihovem ozemlju, ter odvisne družbe in podizvajalce teh priglašenih organov, da bi zagotovili, da so zahteve in obveznosti, določene v tej uredbi, še vedno izpolnjene.
Article 44
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.
Monitoring and re-assessment of notified bodies
Če Komisija ali organ države članice priglašenemu organu s sedežem na ozemlju druge države članice predloži zahtevo v zvezi z ugotavljanjem skladnosti, ki ga je opravil ta priglašeni organ, pošlje izvod te zahteve organu, pristojnemu za priglašene organe, v tej drugi državi članici.
Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated.
Zadevni priglašeni organ nemudoma, najpozneje pa v 15 dneh odgovori na zahtevo.
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.
Organ, pristojen za priglašene organe, države članice, v kateri ima organ sedež, zagotovi, da priglašeni organ reši 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 predloži Koordinacijski skupini za medicinske pripomočke.
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.
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.
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.
Ta pregled vključuje presojo na kraju samem pri vsakem priglašenem organu, po potrebi pa tudi pri odvisnih družbah in podizvajalcih.
The notified body concerned shall respond without delay and within 15 days at the latest to the request.
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.
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.
V tem načrtu je naveden časovni razpored z obrazložitvijo pogostosti ocenjevanja priglašenega organa ter zlasti odvisnih družb in podizvajalcev.
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.
Organ Koordinacijski skupini za medicinske pripomočke in Komisiji predloži letni načrt za spremljanje ali ocenjevanje za vsak priglašeni organ, za katerega je pristojen.
That review shall include an on-site audit of each notified body and, where necessary, of its subsidiaries and subcontractors.
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 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, pri spremljanju priglašenih organov kot pomoč pri usmerjanju svojih dejavnosti upošteva podatke, pridobljene pri nadzoru trga, vigilanci in nadzoru po dajanju na trg.
That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular, associated subsidiaries and subcontractors.
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 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, 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 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 is in the process of conducting quality management system assessments at a manufacturer's facility.
Organ, pristojen za priglašene organe, pregleda, kako so priglašeni organi ocenili proizvajalčevo tehnično dokumentacijo, zlasti dokumentacijo o klinični oceni iz člena 45.
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, 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.
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 države članice, v kateri ima organ sedež, in skupna ocenjevalna ekipa, imenovana za namen postopka iz členov 38 in 39, tri leta po priglasitvi priglašenega organa in nato vsako četrto leto ponovno celovito ocenita, ali priglašeni organ še vedno izpolnjuje zahteve, določene v Prilogi VII.
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.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115, da se spremeni odstavek 10, tako da se določi drugačna pogostost izvajanja ponovnega celovitega ocenjevanja iz zadevnega odstavka.
The authority responsible for notified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in Article 45.
Države članice Komisiji in Koordinacijski skupini za medicinske pripomočke vsaj enkrat na leto poročajo o svojih dejavnostih spremljanja in ocenjevanja na kraju samem v zvezi s priglašenimi organi in po potrebi v zvezi z odvisnimi družbami in podizvajalci.
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.
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.
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 38 and 39.
Povzetek poročila se naloži v elektronski sistem iz člena 57.
The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend paragraph 10 to modify the frequency at which the complete re-assessment referred to in that paragraph is to be carried out.
Člen 45
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.
Pregled ocene, ki jo v zvezi s tehnično dokumentacijo in dokumentacijo o klinični oceni opravi priglašeni organ
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.
Organ, pristojen za priglašene organe, v okviru stalnega spremljanja priglašenih organov pregleda ustrezno število ocen proizvajalčeve tehnične dokumentacije, zlasti dokumentacije o klinični oceni iz točk (c) in (d) oddelka 6.1 Priloge II, ki jih opravi priglašeni organ, da se preverijo ugotovitve, do katerih je prišel priglašeni organ na podlagi informacij proizvajalca.
The summary of the report shall be uploaded to the electronic system referred to in Article 57.
Organ, pristojen za priglašene organe, izvaja te preglede kraju samem in drugod.
Article 45
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 ta to zahteva.
Review of notified body assessment of technical documentation and clinical evaluation documentation
Organ, pristojen za priglašene organe, pregleda, ali je priglašeni organ ustrezno opravil oceno, ter preveri uporabljene postopke, pripadajočo dokumentacijo in ugotovitve priglašenega organa.
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 clinical evaluation documentation as referred to in points (c) and (d) of Section 6.1 of Annex II to verify the conclusions drawn by the notified body based on the information presented by the manufacturer.
Takšno preverjanje vključuje tehnično dokumentacijo in dokumentacijo o klinični oceni proizvajalca, ki jih je priglašeni organ uporabil za svojo oceno.
The reviews by the authority responsible for notified bodies shall be conducted both off-site and on-site.
Takšni pregledi se izvedejo z uporabo skupnih specifikacij.
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.
Ti pregledi so tudi del ponovne ocene priglašenih organov v skladu s členom 44(10) in skupnih dejavnosti ocenjevanja iz člena 47(3).
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.
Ti pregledi se izvedejo ob uporabi ustreznega strokovnega znanja.
Such checking shall include the technical documentation and clinical evaluation documentation of the manufacturer upon which the notified body has based its assessment.
Koordinacijska skupina za medicinske pripomočke lahko na podlagi poročil organov, pristojnih za priglašene organe, ali skupnih ocenjevalnih ekip o teh pregledih in ocenah, na podlagi podatkov, pridobljenih med dejavnostmi nadzora trga, vigilance in nadzora po dajanju na trg, opisanimi v poglavju VII, 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 klinični oceni, ki jih je ocenil priglašeni organ.
Such reviews shall be conducted utilising CS.
Komisija lahko z izvedbenimi akti sprejme ukrepe, v katerih določi podrobne ureditve in spremne dokumente za pregled ocen tehnične dokumentacije in dokumentacije o klinični oceni ter za njegovo usklajevanje, kakor je navedeno v tem členu.
Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 44(10) and the joint assessment activities referred to in Article 47(3).
Člen 46
The reviews shall be conducted utilising appropriate expertise.
Spremembe imenovanj in priglasitev
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, 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 clinical evaluation documentation assessed by 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 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 clinical evaluation documentation, as referred to in this Article.
Postopki iz členov 39 in 42 se uporabljajo za razširitev področja uporabe imenovanja.
Article 46
Za druge spremembe imenovanja, torej ne za razširitev njegovega področja uporabe, se uporabljajo postopki, opisani v spodnjih odstavkih.
Changes to designations and notifications
Komisija spremenjeno priglasitev nemudoma objavi v NANDO.
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.
Komisija informacije o spremembi imenovanja priglašenega organa nemudoma vnese v elektronski sistem iz člena 57.
The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.
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.
For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.
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 Commission shall immediately publish the amended notification in NANDO.
Novi priglašeni organ opravi celotno oceno zadevnih pripomočkov do konca tega obdobja, šele nato izda nove certifikate za te pripomočke.
The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57.
Če je priglašeni organ prenehal z dejavnostjo, organ, pristojen za priglašene organe, imenovanje prekliče.
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 organ, pristojen za priglašene organe, ugotovi, da priglašeni organ ne izpolnjuje več zahtev, določenih v Prilogi VII, ali da ne spoštuje svojih obveznosti ali da ni izvedel potrebnih korektivnih ukrepov, glede na resnost neizpolnjevanja navedenih zahtev ali nespoštovanja obveznosti začasno prekliče, omeji oziroma v celoti ali delno prekliče imenovanje.
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.
Začasni preklic ne sme presegati obdobja enega leta, ki se lahko podaljša enkrat za enako obdobje.