natgillin/translations-raw huggingface dataset:
Certifikaterne kan forblive gyldige i en midlertidig periode på ni måneder, efter at det bemyndigede organs aktiviteter er indstillet, forudsat at et andet bemyndiget organ skriftligt har bekræftet, at det vil påtage sig ansvaret for det udstyr, der er omfattet af disse certifikater.
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.
Det nye bemyndigede organ foretager en fuld vurdering af det berørte udstyr inden udgangen af denne periode, før det udsteder nye certifikater for dette udstyr.
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.
Hvis det bemyndigede organ har indstillet sine aktiviteter, skal myndigheden med ansvar for bemyndigede organer tilbagekalde udpegelsen.
Article 46
Hvis en myndighed med ansvar for bemyndigede organer har konstateret, at et bemyndiget organ ikke længere opfylder kravene i bilag VII, eller at det ikke opfylder sine forpligtelser eller ikke har gennemført de nødvendige korrigerende foranstaltninger, skal myndigheden suspendere, begrænse eller helt eller delvis tilbagekalde udpegelsen, afhængigt af i hvor alvorlig grad det bemyndigede organ ikke opfylder disse krav eller forpligtelser.
Changes to designations and notifications
En suspension må ikke vare længere end et år og kan forlænges én gang med yderligere et år.
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.
Myndigheden med ansvar for bemyndigede organer skal straks underrette Kommissionen og de øvrige medlemsstater om enhver suspension, begrænsning eller tilbagekaldelse af en udpegelse.
The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.
Hvis et bemyndiget organs udpegelse er blevet suspenderet, begrænset eller helt eller delvist tilbagekaldt, underretter dette organ de pågældende fabrikanter inden for senest 10 dage.
For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.
Hvis en udpegelse begrænses, suspenderes eller tilbagekaldes, skal myndigheden med ansvar for bemyndigede organer tage hensigtsmæssige skridt til at sikre, at det pågældende bemyndigede organs dokumenter opbevares, og stille dem til rådighed for myndigheder i andre medlemsstater med ansvar for bemyndigede organer og for myndigheder med ansvar for markedsovervågning på disses anmodning.
The Commission shall immediately publish the amended notification in NANDO.
Hvis en udpegelse begrænses, suspenderes eller tilbagekaldes, skal myndigheden med ansvar for bemyndigede organer:
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.
vurdere indvirkningen på certifikater, der er udstedt af det bemyndigede organ
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.
forelægge en rapport om sine resultater til Kommissionen og de øvrige medlemsstater senest tre måneder efter, at den har givet meddelelse om ændringerne af udpegelsen
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.
pålægge det bemyndigede organ at suspendere eller tilbagekalde alle certifikater, der uretmæssigt er blevet udstedt, inden for en rimelig tidsfrist, der fastsættes af myndigheden, for at sikre beskyttelsen af udstyr på markedet
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.
i det elektroniske system, der er omhandlet i artikel 57, indføre oplysninger vedrørende certifikater, som den har krævet suspenderet eller tilbagekaldt
Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation.
underrette den kompetente myndighed for medicinsk udstyr i den medlemsstat, hvor fabrikanten har sit registrerede forretningssted, gennem det elektroniske system, der er omhandlet i artikel 57, om de certifikater, som den har krævet suspenderet eller tilbagekaldt.
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.
Den kompetente myndighed træffer de fornødne foranstaltninger, hvis det er nødvendigt for at undgå en potentiel risiko for patienters, brugeres eller andre personers sundhed eller sikkerhed.
A suspension shall not exceed a period of one year, renewable once for the same period.
Med undtagelse af uretmæssigt udstedte certifikater og tilfælde, hvor en udpegelse er blevet suspenderet eller begrænset, vedbliver certifikaterne med at være gyldige i følgende tilfælde:
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.
myndigheden med ansvar for bemyndigede organer har senest én måned efter suspensionen eller begrænsningen bekræftet, at der ikke er noget sikkerhedsproblem vedrørende certifikater, der er berørt af suspensionen eller begrænsningen og myndigheden med ansvar for bemyndigede organer har angivet en frist og forventede foranstaltninger til at afhjælpe suspensionen eller begrænsningen, eller
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.
myndigheden med ansvar for bemyndigede organer har bekræftet, at ingen certifikater af relevans for suspensionen vil blive udstedt, ændret eller genudstedt under suspensionen eller begrænsningen, og anfører, hvorvidt det bemyndigede organ har kapacitet til at fortsætte med at føre tilsyn med og fortsat være ansvarligt for eksisterende udstedte certifikater i suspensions- eller begrænsningsperioden.
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.
Hvis myndigheden med ansvar for bemyndigede organer afgør, at det bemyndigede organ ikke har kapacitet til at støtte eksisterende udstedte certifikater, skal fabrikanten senest tre måneder efter suspensionen eller begrænsningen skriftligt bekræfte over for den kompetente myndighed for medicinsk udstyr i den medlemsstat, hvor fabrikanten af det udstyr, der er omfattet af certifikatet, har sit registrerede forretningssted, at et andet kvalificeret bemyndiget organ midlertidigt varetager det bemyndigede organs funktioner med hensyn til at føre tilsyn med og fortsat være ansvarligt for certifikaterne i suspensions- eller begrænsningsperioden.
In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall:
Med undtagelse af uretmæssigt udstedte certifikater og tilfælde, hvor en udpegelse er blevet tilbagekaldt, vedbliver certifikaterne med at være gyldige i ni måneder i følgende tilfælde:
assess the impact on the certificates issued by the notified body;
hvis den kompetente myndighed for medicinsk udstyr i den medlemsstat, hvor fabrikanten af det udstyr, der er omfattet af certifikaterne, har sit registrerede forretningssted, har bekræftet, at der ikke er noget sikkerhedsproblem forbundet med det pågældende udstyr, og
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;
et andet bemyndiget organ skriftligt har bekræftet, at det straks varetager ansvaret for dette udstyr og vil have færdiggjort vurderingen af det inden 12 måneder efter tilbagekaldelse af udpegelsen.
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;
Under de omstændigheder, der er omhandlet i første afsnit, kan den kompetente myndighed for medicinsk udstyr i den medlemsstat, hvor fabrikanten af det udstyr, der er omfattet af certifikatet, har sit registrerede forretningssted, forlænge certifikaternes foreløbige gyldighed i yderligere perioder på tre måneder, dog i alt højst 12 måneder.
enter into the electronic system referred to in Article 57 information in relation to certificates of which it has required their suspension or withdrawal;
Den myndighed eller det bemyndigede organ, der har påtaget sig funktionerne for det bemyndigede organ, der er berørt af ændringen af udpegelsen, underretter straks Kommissionen, medlemsstaterne og de øvrige bemyndigede organer herom.
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.
Artikel 47
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.
Anfægtelse af bemyndigede organers kompetence
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:
Kommissionen undersøger sammen med MDCG alle sager, hvor den er blevet gjort opmærksom på betænkeligheder vedrørende et bemyndiget organs, eller en eller flere af dets dattervirksomheders eller underentreprenørers, fortsatte opfyldelse af kravene i bilag VII eller de forpligtelser, der påhviler dem.
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
Den skal sikre, at den relevante myndighed med ansvar for bemyndigede organer underrettes og får mulighed for at undersøge disse betænkeligheder.
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.
Den bemyndigende medlemsstat forelægger efter anmodning Kommissionen alle oplysninger om udpegelsen af det pågældende bemyndigede organ.
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.
Kommissionen kan sammen med MDCG, hvis det er relevant, indlede den vurderingsprocedure, der er beskrevet i artikel 39, stk. 3 og 4, når der er rimelig grund til bekymring for, om et bemyndiget organ eller et bemyndiget organs dattervirksomhed eller underentreprenør til stadighed opfylder kravene i bilag VII, og når undersøgelsen foretaget af myndigheden med ansvar for de bemyndigede organer ikke vurderes at have imødekommet denne bekymring fuldt ud eller efter anmodning fra myndigheden med ansvar for bemyndigede organer.
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:
Indrapporteringen og resultatet af denne vurderingsprocedure skal følge principperne i artikel 39.
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
Alternativt kan Kommissionen, afhængigt af hvor alvorligt spørgsmålet er, sammen med MDCG anmode om, at myndigheden med ansvar for bemyndigede organer giver op til to eksperter fra den liste, der er oprettet i henhold til artikel 40, tilladelse til at deltage i en vurdering på stedet som led i de planlagte tilsyns- og vurderingsaktiviteter i overensstemmelse med artikel 44 og som angivet i den årlige vurderingsplan, der er beskrevet i artikel 44, stk. 4.
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.
Hvis Kommissionen konstaterer, at et bemyndiget organ ikke længere opfylder kravene vedrørende dets udpegelse, skal den underrette den bemyndigende medlemsstat herom og anmode den om at træffe de nødvendige korrigerende foranstaltninger, herunder om nødvendigt suspension, begrænsning eller tilbagekaldelse af udpegelsen.
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.
Hvis medlemsstaten ikke træffer de nødvendige korrigerende foranstaltninger, kan Kommissionen ved hjælp af gennemførelsesretsakter suspendere, begrænse eller tilbagekalde udpegelsen.
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.
Den underretter den pågældende medlemsstat om sin afgørelse og opdaterer NANDO og det elektroniske system, der er omhandlet i artikel 57.
Article 47
Kommissionen sikrer, at alle fortrolige oplysninger, som den indhenter som led i sine undersøgelser, behandles i overensstemmelse hermed.
Challenge to the competence of notified bodies
Artikel 48
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.
Peer review og udveksling af erfaringer mellem myndigheder med ansvar for bemyndigede organer
It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns.
Kommissionen sørger for at organisere udveksling af erfaringer og koordinering af administrativ praksis mellem myndighederne med ansvar for bemyndigede organer.
The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned.
En sådan udveksling skal omfatte elementer som bl.a.:
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.
udarbejdelse af dokumenter om bedste praksis vedrørende aktiviteterne i myndighederne med ansvar for bemyndigede organer
The reporting and outcome of that assessment shall follow the principles of Article 39.
udarbejdelse af dokumenter med vejledning for bemyndigede organer med hensyn til gennemførelsen af denne forordning
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).
eksperternes uddannelse og kvalifikationer, jf. artikel 40
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.
monitorering af tendenser vedrørende ændringer af udpegelser og notifikationer af bemyndigede organer og tendenser med hensyn til tilbagekaldelser af certifikater og overførsler heraf mellem bemyndigede organer
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.
monitorering af anvendelsen og anvendeligheden af koder, der beskriver rammerne, jf. artikel 42, stk. 13
It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 57.
udvikling af en mekanisme til peer review mellem myndigheder og Kommissionen
The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly.
metoder til kommunikation til offentligheden om myndighedernes og Kommissionens tilsyns- og overvågningsaktiviteter vedrørende bemyndigede organer.
Article 48
Myndighederne med ansvar for bemyndigede organer deltager i et peer review hvert tredje år ved hjælp af den mekanisme, der er udviklet i henhold til denne artikels stk. 1.
Peer review and exchange of experience between authorities responsible for notified bodies
Sådanne peer reviews skal normalt gennemføres parallelt med de vurderinger på stedet, der er beskrevet i artikel 39.
The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies.
Alternativt kan en myndighed vælge, at sådanne peer reviews skal finde sted som en del af dens tilsynsaktiviteter, jf. artikel 44.
Such exchange shall cover elements including:
Kommissionen deltager i tilrettelæggelsen og yder støtte til implementeringen af peer review-mekanismen.
development of best practice documents relating to the activities of the authorities responsible for notified bodies;
Kommissionen skal udarbejde en årlig sammenfattende rapport for peer review-aktiviteterne, der gøres offentligt tilgængelig.
development of guidance documents for notified bodies in relation to the implementation of this Regulation;
Kommissionen kan ved hjælp af gennemførelsesretsakter vedtage foranstaltninger, der fastsætter de nærmere bestemmelser og tilhørende dokumenter i forbindelse med peer review-mekanismen og uddannelse og kvalifikationer, jf. denne artikels stk. 1.
training and qualification of the experts referred to in Article 40;
Artikel 49
monitoring of trends relating to changes to notified body designations and notifications and trends in certificate withdrawals and transfers between notified bodies;
Koordinering af bemyndigede organer
monitoring of the application and applicability of scope codes referred to in Article 42(13);
Kommissionen sikrer, at der etableres passende koordinering og samarbejde mellem de bemyndigede organer, og at denne koordinering og dette samarbejde fungerer i form af en koordineringsgruppe af bemyndigede organer for medicinsk udstyr, herunder medicinsk udstyr til in vitro-diagnostik.
development of a mechanism for peer reviews between authorities and the Commission;
Denne gruppe mødes regelmæssigt og mindst en gang om året.
methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.
De organer, der er bemyndiget i henhold til denne forordning, deltager i denne gruppes arbejde.
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.
Kommissionen kan fastsætte nærmere bestemmelser for arbejdet i koordineringsgruppen af bemyndigede organer.
Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 39.
Artikel 50
Alternatively, an authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 44.
Liste over standardgebyrer
The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism.
De bemyndigede organer opstiller lister over deres standardgebyrer for de overensstemmelsesvurderingsaktiviteter, som de udfører, og gør disse lister offentligt tilgængelige.
The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available.
KAPITEL V
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.
KLASSIFICERING OG OVERENSSTEMMELSESVURDERING
Article 49
AFDELING 1
Coordination of notified bodies
Klassificering
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.
Artikel 51
This group shall meet on a regular basis and at least annually.
Klassificering af udstyr
The bodies notified under this Regulation shall participate in the work of that group.
Udstyr inddeles i klasse I, IIa, IIb og III under hensyn til udstyrets erklærede formål og de dermed forbundne risici.
The Commission may establish the specific arrangements for the functioning of the coordination group of notified bodies.
Klassificeringen foretages i overensstemmelse med bilag VIII.
Article 50