natgillin/translations-raw huggingface dataset:
Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating competent authority shall inform the manufacturer, or where applicable the authorised representative, which shall then take the necessary corrective actions.
poročanjem o resnih zapletih in varnostnih korektivnih ukrepih ter obvestili o varnostnih korektivnih ukrepih in predložitvijo rednih zbirnih poročil, poročil o nadzoru po dajanju na trg, redno posodobljenih poročil o varnosti in poročil o trendih, ki jih proizvajalci predložijo v skladu s členi 80, 81, 82, 83 oziroma 84;
Article 86
standardnimi obrazci za elektronsko in neelektronsko poročanje, vključno z minimalnim sklopom podatkov za poročanje o domnevnih resnih zapletih s strani zdravstvenih delavcev, uporabnikov in pacientov;
The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the detailed arrangements and procedural aspects necessary for the implementation of Articles 80 to 85 and 87 as regards the following:
roki za poročanje o varnostnih korektivnih ukrepih ter roki, ki jih morajo proizvajalci upoštevati pri predložitvi rednih zbirnih poročil in poročil o trendih, ob upoštevanju resnosti dogodka, o katerem je treba poročati v skladu s členom 82;
the typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices;
harmoniziranimi obrazci za izmenjavo informacij med pristojnimi organi iz člena 84;
the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 80, 81, 82, 83 and 84 respectively;
postopki za določitev usklajevalnega pristojnega organa; usklajenim postopkom ocenjevanja, vključno z nalogami in pristojnostmi usklajevalnega pristojnega organa in sodelovanjem drugih pristojnih organov v tem postopku.
standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting of suspected serious incidents by healthcare professionals, users and patients;
Člen 87
timelines for the reporting of field safety corrective actions, and for the provision by manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be reported as referred to in Article 82;
Elektronski sistem za vigilanco in nadzor po dajanju na trg
harmonised forms for the exchange of information between competent authorities as referred to in Article 84;
Komisija v sodelovanju z državami članicami vzpostavi in upravlja elektronski sistem za zbiranje in obdelavo naslednjih informacij:
procedures for the designation of a coordinating competent authority; the coordinated evaluation process, including tasks and responsibilities of the coordinating competent authority and involvement of other competent authorities in this process.
poročil proizvajalcev o resnih zapletih in varnostnih korektivnih ukrepih iz člena 82(1) in člena 84(5);
Article 87
rednih zbirnih poročil proizvajalcev iz člena 82(9);
Electronic system on vigilance and post-market surveillance
poročil proizvajalcev o trendih iz člena 83;
The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information:
redno posodobljenih poročil o varnosti iz člena 81;
reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 82(1) and Article 84(5);
obvestil proizvajalcev o varnostnih korektivnih ukrepih iz člena 84(8);
the periodic summary reports by manufacturers referred to in Article 82(9);
informacij, ki se izmenjujejo med pristojnimi organi držav članic ter med njimi in Komisijo v skladu s členom 84(7) in (9).
the reports by manufacturers on trends referred to in Article 83;
Ta elektronski sistem vključuje ustrezne povezave do podatkovne zbirke UDI.
the PSURs referred to in Article 81;
Pristojni organi držav članic in Komisija imajo prek elektronskega sistema dostop do informacij iz odstavka 1 tega člena.
the field safety notices by manufacturers referred to in Article 84(8);
Do njih imajo dostop tudi priglašeni organi, kolikor se te informacije nanašajo na pripomočke, za katere so v skladu s členom 49 izdali certifikat.
the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 84(7) and (9).
Komisija zagotovi, da imajo zdravstveni delavci in javnost ustrezno raven dostopa do elektronskega sistema iz odstavka 1.
That electronic system shall include relevant links to the UDI database.
Komisija lahko pristojnim organom tretjih držav ali mednarodnim organizacijam na podlagi sporazumov z njimi odobri ustrezno raven dostopa do elektronskega sistema iz odstavka 1.
The information referred to in paragraph 1 of this Article shall be made available through the electronic system to the competent authorities of the Member States and to the Commission.
Navedeni sporazumi temeljijo na vzajemnosti ter zagotavljajo isto raven zaupnosti in varstva podatkov, kot se zahteva v Uniji.
The notified bodies shall also have access to that information to the extent that it relates to devices for which they issued a certificate in accordance with Article 49.
Poročila o resnih zapletih iz točke (a) člena 82(1) se po prejemu samodejno posredujejo prek elektronskega sistema iz odstavka 1 tega člena pristojnemu organu države članice, v kateri se je zaplet zgodil.
The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system referred to in paragraph 1.
Poročila o trendih iz člena 83(1) se po prejemu samodejno posredujejo prek elektronskega sistema iz odstavka 1 tega člena pristojnim organom držav članic, v katerih so se zapleti zgodili.
On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the electronic system referred to in paragraph 1 at the appropriate level.
Poročila o varnostnih korektivnih ukrepih iz točke (b) člena 82(1) se po prejemu samodejno posredujejo prek elektronskega sistema iz odstavka 1 tega člena pristojnim organom naslednjih držav članic:
Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union.
države članice, v kateri se sprejema ali bo sprejet varnostni korektivni ukrep;
The reports on serious incidents referred to in point (a) of Article 82(1), shall be automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the Member State in which the incident occurred.
države članice, v kateri ima proizvajalec registrirani kraj poslovanja.
The trend reports referred to in Article 83(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the Member States in which the incidents occurred.
Redna zbirna poročila iz člena 82(9) se po prejemu samodejno posredujejo prek elektronskega sistema iz odstavka 1 tega člena pristojnemu organu:
The reports on field safety corrective actions referred to in point (b) of Article 82(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the following Member States:
države članice ali držav članic, ki sodelujejo v usklajevalnem postopku v skladu s členom 84(9) in so se strinjale z rednim zbirnim poročilom;
the Member State in which the field safety corrective action is being or is to be undertaken;
Informacije iz odstavkov 5 do 8 tega člena se po prejemu samodejno posredujejo prek elektronskega sistema iz odstavka 1 tega člena priglašenemu organu, ki je izdal certifikat za zadevni pripomoček v skladu s členom 51.
the Member State in which the manufacturer has its registered place of business.
Oddelek 3
The periodic summary reports referred to in Article 82(9) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of:
Nadzor trga
the Member State or Member States participating in the coordination procedure in accordance with Article 84(9) and which have agreed on the periodic summary report;
Člen 88
The information referred to in paragraphs 5 to 8 of this Article shall be automatically transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this Article, to the notified body that issued the certificate for the device in question in accordance with Article 51.
Dejavnosti nadzora trga
Section 3
Pristojni organi izvajajo ustrezne preglede skladnosti in učinkovitosti pripomočkov, po potrebi tudi pregled dokumentacije in fizične ali laboratorijske preglede na podlagi ustreznih vzorcev.
Market surveillance
Pristojni organi zlasti upoštevajo uveljavljena načela glede ocene tveganja in obvladovanja tveganja, podatke o vigilanci in pritožbe.
Article 88
Pristojni organi pripravijo letne načrte dejavnosti nadzora in zagotovijo zadostno število materialnih in strokovnih človeških virov, potrebnih za izvajanje teh dejavnosti, ob upoštevanju evropskega programa za nadzor trga, ki ga je razvila Koordinacijska skupina za medicinske pripomočke v skladu s členom 99, in lokalnih okoliščin.
Market surveillance activities
Pristojni organi zaradi izpolnjevanja obveznosti iz odstavka 1:
The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples.
lahko od gospodarskih subjektov med drugim zahtevajo dostop do dokumentacije in informacij, ki so potrebne za izvajanje dejavnosti organov, ter, kadar je to upravičeno, da zagotovijo potrebne brezplačne vzorce pripomočkov ali brezplačni dostop do pripomočkov ter
The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints.
opravijo napovedane in, če je to potrebno, nenapovedane inšpekcijske preglede prostorov gospodarskih subjektov ter dobaviteljev in/ali podizvajalcev, po potrebi pa tudi objektov poklicnih uporabnikov.
The competent authorities shall draw up annual surveillance activity plans and allocate a sufficient number of material and competent human resources in order to carry out those activities taking into account the European market surveillance programme developed by the MDCG pursuant to Article 99 and local circumstances.
Pristojni organi pripravijo letni povzetek rezultatov svojih dejavnosti nadzora in jih prek elektronskega sistema iz člena 95 dajo na voljo drugim pristojnim organom.
In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
Pristojni organi lahko pripomočke, ki pomenijo nesprejemljivo tveganje, ali ponarejene pripomočke zasežejo, uničijo ali drugače onemogočijo njihovo delovanje, če menijo, da je to potrebno zaradi varovanja javnega zdravja.
may require economic operators to, inter alia, make available the documentation and information necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of devices or access to devices free of charge; and
Po vsakem inšpekcijskem pregledu, opravljenem za namene iz odstavka 1, pristojni organ pripravi poročilo o ugotovitvah inšpekcijskega pregleda v zvezi s skladnostjo z zakonskimi in tehničnimi zahtevami, ki se uporabljajo na podlagi te uredbe.
shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users.
V poročilu so navedeni vsi potrebni korektivni ukrepi.
The competent authorities shall prepare an annual summary of the results of their surveillance activities and make it accessible to other competent authorities by means of the electronic system referred to in Article 95.
Pristojni organ, ki je opravil inšpekcijski pregled, vsebino poročila iz odstavka 6 tega člena pošlje gospodarskemu subjektu, pri katerem je bil opravljen inšpekcijski pregled.
The competent authorities may confiscate, destroy or otherwise render inoperable devices that present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the protection of public health.
Pristojni organ pred sprejetjem končnega poročila temu gospodarskemu subjektu omogoči, da predloži pripombe.
Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority shall draw up a report on the findings of the inspection that concern compliance with the legal and technical requirements applicable under this Regulation.
To končno poročilo o inšpekcijskem pregledu se vnese v elektronski sistem iz člena 95.
The report shall set out any corrective actions needed.
Države članice pregledujejo in ocenjujejo delovanje svojih dejavnosti nadzora trga.
The competent authority which carried out the inspection shall communicate the content of the report referred to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection.
Ti pregledi in ocene se izvajajo vsaj vsaka štiri leta, rezultati pregledov in ocen pa se sporočijo ostalim državam članicam in Komisiji.
Before adopting the final report, the competent authority shall give that economic operator the opportunity to submit comments.
Vsaka država članica prek elektronskega sistema iz člena 95 javnosti omogoči dostop do povzetka rezultatov.
That final inspection report shall be entered in the electronic system provided for in Article 95.
Pristojni organi države članice usklajujejo svoje dejavnosti nadzora trga, sodelujejo z drugimi pristojnimi organi ter z njimi in s Komisijo izmenjujejo rezultate teh dejavnosti, da zagotovijo harmonizirano in visoko raven nadzora trga v vseh državah članicah.
The Member States shall review and assess the functioning of their market surveillance activities.
Pristojni organi države članice se po potrebi dogovorijo o delitvi dela, skupnih dejavnostih nadzora trga in specializaciji.
Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission.
Če je v državi članici za nadzor trga ali nadzor zunanjih meja pristojnih več organov, ti organi med seboj sodelujejo z izmenjavo informacij, ki so pomembne za njihovo vlogo in njihove naloge.
Each Member State shall make a summary of the results accessible to the public by means of the electronic system referred to in Article 95.
Pristojni organi držav članic po potrebi sodelujejo s pristojnimi organi tretjih držav, da bi izmenjevali informacije in tehnično pomoč ter spodbujali dejavnosti, povezane z nadzorom trga.
The competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof, to provide for a harmonised and high level of market surveillance in all Member States.
Člen 89
Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint market surveillance activities and specialisation.
Ocena pripomočkov, za katere se domneva, da pomenijo nesprejemljivo tveganje ali da so drugače neskladni z zahtevami
Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions.
Kadar pristojni organi v državi članici na podlagi podatkov, pridobljenih z vigilanco ali dejavnostmi nadzora trga, ali drugih informacij domnevajo, da lahko pripomoček:
Where appropriate, the competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance.
pomeni nesprejemljivo tveganje za zdravje ali varnost pacientov, uporabnikov ali drugih oseb ali za druge vidike varovanja javnega zdravja ali
Article 89
kako drugače ni v skladu z zahtevami iz te uredbe,
Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
ocenijo, ali zadevni pripomoček izpolnjuje vse zahteve iz te uredbe, ki se nanašajo na tveganje, ki ga pomeni pripomoček, ali za kakršno koli drugačno neskladnost pripomočka.
Where the competent authorities of a Member State, based on data obtained by vigilance or market surveillance activities or on other information, have reason to believe that a device:
Zadevni gospodarski subjekti sodelujejo s pristojnimi organi.
may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or
Člen 90
otherwise does not comply with the requirements laid down in this Regulation,
Postopek za obravnavo pripomočkov, ki pomenijo nesprejemljivo tveganje za zdravje in varnost
they shall carry out an evaluation of the device concerned covering all requirements laid down in this Regulation relating to the risk presented by the device or to any other non-compliance of the device.
Kadar pristojni organi po oceni v skladu s členom 89 ugotovijo, da pripomoček pomeni nesprejemljivo tveganje za zdravje ali varnost pacientov, uporabnikov ali drugih oseb ali za druge vidike varovanja javnega zdravja, od proizvajalca zadevnih pripomočkov, njegovega pooblaščenega predstavnika in vseh drugih zadevnih gospodarskih subjektov nemudoma zahtevajo, da sprejmejo vse ustrezno utemeljene korektivne ukrepe, s katerimi zagotovijo skladnost pripomočka z zahtevami te uredbe, ki se nanašajo na tveganje, ki ga pomeni pripomoček, in s katerimi na način, ki je sorazmeren z naravo tveganja, omejijo omogočanje dostopnosti pripomočka na trgu, dovolijo omogočanje dostopnosti pripomočka pod določenimi zahtevami, umaknejo pripomoček s trga ali ga odpokličejo v razumnem roku, ki je jasno določen in sporočen zadevnemu gospodarskemu subjektu.
The relevant economic operators shall cooperate with the competent authorities.
Pristojni organi Komisijo, druge države članice in – v primeru, ko je bil certifikat za zadevni pripomoček izdan v skladu s členom 51 – priglašeni organ, ki je izdal zadevni certifikat, prek elektronskega sistema iz člena 95 nemudoma uradno obvestijo o rezultatih ocene in sprejetih ukrepih, ki so jih zahtevali od gospodarskih subjektov.
Article 90
Gospodarski subjekti iz odstavka 1 nemudoma zagotovijo sprejetje vseh ustreznih korektivnih ukrepov povsod v Uniji za vse zadevne pripomočke, katerih dostopnost so omogočili na trgu.
Procedure for dealing with devices presenting an unacceptable risk to health and safety
Kadar gospodarski subjekt iz odstavka 1 ne sprejme ustreznih korektivnih ukrepov v roku iz odstavka 1, pristojni organi sprejmejo vse ustrezne ukrepe za prepoved ali omejitev dostopnosti pripomočka na nacionalnem trgu ali pa ga z njega umaknejo ali odpokličejo.
Where, having performed an evaluation pursuant to Article 89, the competent authorities find that the device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall without delay require the manufacturer of the devices concerned, its authorised representative and all other relevant economic operators to take all appropriate and duly justified corrective action to bring the device into compliance with the requirements of this Regulation relating to the risk presented by the device and, in a manner that is proportionate to the nature of the risk, to restrict the making available of the device on the market, to subject the making available of the device to specific requirements, to withdraw the device from the market, or to recall it, within a reasonable period that is clearly defined and communicated to the relevant economic operator.
Pristojni organi prek elektronskega sistema iz člena 95 nemudoma uradno obvestijo Komisijo, druge države članice in priglašeni organ iz odstavka 2 tega člena o teh ukrepih.
The competent authorities shall, without delay, notify the Commission, the other Member States and, where a certificate has been issued in accordance with Article 51 for the device concerned, the notified body that issued that certificate, of the results of the evaluation and of the actions which they have required the economic operators to take, by means of the electronic system referred to in Article 95.
Uradno obvestilo iz odstavka 4 vsebuje vse razpoložljive podatke, zlasti podatke, potrebne za identifikacijo neskladnega pripomočka in njegovo sledenje, ter podatke o poreklu pripomočka, vrsti domnevne neskladnosti in razlogih zanjo in s tem povezanim tveganjem, vrsti in trajanju sprejetih nacionalnih ukrepov ter stališču zadevnega gospodarskega subjekta.
The economic operators as referred to in paragraph 1 shall, without delay, ensure that all appropriate corrective action is taken throughout the Union in respect of all the devices concerned that they have made available on the market.
Države članice, razen države članice, ki je sprožila postopek, prek elektronskega sistema iz člena 95 nemudoma obvestijo Komisijo in druge države članice o vseh dodatnih pomembnih informacijah, ki so jim na voljo in se nanašajo na neskladnost zadevnega pripomočka, in o vseh ukrepih, ki so jih sprejele v zvezi z zadevnim pripomočkom.
Where the economic operator as referred to in paragraph 1 does not take adequate corrective action within the period referred to in paragraph 1, the competent authorities shall take all appropriate measures to prohibit or restrict the making available of the device on their national market, to withdraw the device from that market or to recall it.
V primeru nestrinjanja s priglašenim nacionalnim ukrepom Komisijo in druge države članice prek elektronskega sistema iz člena 95 nemudoma obvestijo o svojem ugovoru.
The competent authorities shall notify the Commission, the other Member States and the notified body referred to in paragraph 2 of this Article, without delay, of those measures, by means of the electronic system referred to in Article 95.
Če v dveh mesecih po prejemu uradnega obvestila iz odstavka 4 nobena država članica ali Komisija ne vloži ugovora na nobenega od ukrepov, ki jih je sprejela država članica, se šteje, da so navedeni ukrepi upravičeni.
The notification referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification and tracing of the non-compliant device, the origin of the device, the nature of and the reasons for the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
V tem primeru vse države članice zagotovijo takojšnje sprejetje ustreznih omejevalnih ukrepov ali ukrepov prepovedi v zvezi z zadevnim pripomočkom, med katere spadajo tudi umik, odpoklic ali omejevanje razpoložljivosti pripomočka na njihovem nacionalnem trgu.
Member States other than the Member State initiating the procedure shall, without delay, inform the Commission and the other Member States, by means of the electronic system referred to in Article 95, of any additional relevant information at their disposal relating to the non-compliance of the device concerned and of any measures adopted by them in relation to the device concerned.
Člen 91
In the event of disagreement with the notified national measure, they shall, without delay, inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 95.
Postopek za ocenjevanje nacionalnih ukrepov na ravni Unije