natgillin/translations-raw huggingface dataset:
udarbejder en EU-typeafprøvningsrapport om resultaterne af de gennemførte vurderinger og prøvninger og de videnskabelige udtalelser, jf. litra a)-k), herunder en vurderingsrapport om ydeevneevaluering for udstyr i klasse C eller D eller omfattet af punkt 2, tredje led.
The notified body may require the application to be completed by carrying out further tests or by providing further proof to allow assessment of conformity with the requirements of this Regulation.
Certifikat
The notified body shall verify the compliance of the device with the relevant requirements set out in Annex I of this Regulation.
Hvis typen er i overensstemmelse med denne forordning, udsteder det bemyndigede organ et EU-typeafprøvningscertifikat.
The notified body shall assess the application, by using staff, employed by it, with proven knowledge and experience regarding the technology concerned and the intended purpose of the device and provide the manufacturer with a technical documentation assessment report.
Certifikatet skal indeholde fabrikantens navn og adresse, konklusionerne af vurderingen af typeafprøvningen, betingelserne for certifikatets gyldighed samt de nødvendige oplysninger til identifikation af den godkendte type.
The certificate shall contain the conclusions of the assessment, the conditions of its validity, the data needed for the identification of the approved devices and, where appropriate, a description of the intended purpose of the device.
Certifikatet skal udformes i overensstemmelse med bilag XII.
Where the manufacturer plans to introduce any of the above-mentioned changes, it shall inform the notified body which issued the EU technical documentation assessment certificate thereof.
De relevante dele af dokumentationen vedlægges certifikatet, og det bemyndigede organ opbevarer en kopi.
Assessment of the technical documentation of companion diagnostics
Ændringer af typen
The manufacturer of a companion diagnostic shall lodge with the notified body an application for the assessment of the technical documentation.
Ansøgeren underretter det bemyndigede organ, der har udstedt EU-typeafprøvningscertifikatet, om enhver påtænkt ændring af den godkendte type eller dens erklærede formål og brugsbetingelser.
The notified body shall assess that application in accordance with the procedure laid down in Sections 4.1 to 4.8 of this Annex.
Hvis ændringer af det godkendte udstyr, herunder begrænsninger af dets erklærede formål og brugsbetingelser, kan få indflydelse på overensstemmelse med de generelle krav til sikkerhed og ydeevne eller på de foreskrevne betingelser for anvendelse af produktet, skal sådanne ændringer også godkendes af det bemyndigede organ, som har udstedt EU-typeafprøvningscertifikatet.
The application shall enable the characteristics and performance of the device to be understood, and shall enable conformity with the design-related requirements of this Regulation to be assessed, in particular, with regard to the suitability of the device in relation to the medicinal product concerned.
Det bemyndigede organ undersøger de påtænkte ændringer, underretter fabrikanten om sin afgørelse og forelægger fabrikanten et tillæg til EU-typeafprøvningsrapporten.
The notified body shall, before issuing an EU technical documentation assessment certificate for the companion diagnostic and on the basis of the draft summary of safety and performance and the draft instructions for use, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, regarding the suitability of the device in relation to the medicinal product concerned.
Godkendelsen af ændringer af den godkendte type har form af et tillæg til EU-typeafprøvningscertifikatet.
Where the medicinal product falls exclusively within the scope of the Annex to Regulation (EC) No 726/2004 of the European Parliament and of the Council [1], the notified body shall seek the opinion of the EMA.
Ændringer af det godkendte udstyrs erklærede formål og brugsbetingelser med undtagelse af begrænsninger af dets erklærede formål og brugsbetingelser kræver en ny ansøgning om overensstemmelsesvurdering.
If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products authority, or the EMA, that is responsible for the authorisation.
Hvis ændringerne kan påvirke den ydeevne, der er angivet af fabrikanten, eller overensstemmelsen med de fælles specifikationer eller andre løsninger, som er valgt af fabrikanten, og som er godkendt gennem EU-typeafprøvningscertifikatet, skal det bemyndigede organ høre det EU-referencelaboratorium, som var involveret i den første høring, for at få bekræftet, at overensstemmelsen med de fælles specifikationer, hvis sådanne foreligger, eller med andre løsninger, som er valgt af fabrikanten for at sikre et niveau af sikkerhed og ydeevne, som mindst svarer hertil, er opretholdt.
The medicinal products authority consulted shall provide its opinion, within 60 days of receipt of all the necessary documentation.
Hvis ændringerne påvirker ydeevnen ved eller den tilsigtede brug af udstyr beregnet til ledsagende diagnosticering, som blev godkendt gennem EU-typeafprøvningscertifikatet, eller dets egnethed i forbindelse med et lægemiddel, skal det bemyndigede organ høre den kompetente myndighed for lægemidler, som var involveret i den første høring, eller EMA.
This 60-day period may be extended once for a further 60 days on justified grounds.
Den hørte myndighed for lægemidler afgiver i givet fald sin udtalelse senest 30 dage efter modtagelse af gyldig dokumentation vedrørende ændringerne.
The opinion and any possible update shall be included in the documentation of the notified body concerning the device.
Godkendelsen af ændringer af den godkendte type udstedes i form af et tillæg til det oprindelige EU-typeafprøvningscertifikat.
The notified body shall give due consideration to the scientific opinion referred to in point (d) when making its decision.
Administrative bestemmelser
The notified body shall convey its final decision to the medicinal products authority consulted.
Fabrikanten eller, hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, dennes autoriserede repræsentant skal i mindst 10 år, efter at det sidste udstyr er bragt i omsætning, kunne forelægge de kompetente myndigheder:
The EU technical documentation assessment certificate shall be delivered in accordance with point (e) of Section 5.1.
den i punkt 2, andet led, omhandlede dokumentation
Before changes affecting the performance and/or the intended use and/or the suitability of the device in relation to the medicinal product concerned are made, the manufacturer shall inform the notified body of the changes.
oplysninger om de i punkt 5 omhandlede ændringer
In the latter case, the notified body shall assess the changes and seek the opinion of the medicinal products authority consulted.
kopier af EU-typeafprøvningscertifikater, videnskabelige udtalelser og rapporter og tillæg/tilføjelser dertil.
The medicinal products authority consulted shall give its opinion within 30 days of receipt of the all the necessary documentation regarding the changes.
Bilag IX, punkt 7, finder anvendelse.
A supplement to the EU technical documentation assessment certificate shall be issued in accordance with point (f) of Section 5.1.
OVERENSSTEMMELSESVURDERING BASERET PÅ KVALITETSSIKRING AF PRODUKTIONEN
The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, it's authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities:
Fabrikanten sørger for, at det kvalitetsstyringssystem, der er godkendt til fremstilling af det pågældende udstyr, anvendes og udfører en endelig verificering som angivet i punkt 3 og er underlagt den overvågning, der er beskrevet i punkt 4.
the EU declaration of conformity,
Når fabrikanten opfylder kravene i punkt 1, udarbejder og opbevarer denne en EU-overensstemmelseserklæring, jf. artikel 17 og bilag IV, for det udstyr, der er omfattet af overensstemmelsesvurderingsproceduren.
the documentation referred to in the fifth indent of Section 2.1. and, in particular, the data and records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2.,
Ved at udstede en EU-overensstemmelseserklæring anses fabrikanten for at sørge for og for at erklære, at det pågældende udstyr opfylder de relevante krav i denne forordning, som udstyret er omfattet af, og for så vidt angår udstyr i klasse C og D, som underkastes typeafprøvning, er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet.
information on the changes referred to in Section 2.4.,
Kvalitetsstyringssystem
the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and
alle de elementer, der er anført i bilag IX, punkt 2.1
the decisions and reports from the notified body as referred to in this Annex.
den i bilag II og III omhandlede tekniske dokumentation for de godkendte typer
Each Member State shall require that the documentation referred to in Section 6 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period.
en kopi af EU-typeafprøvningscertifikaterne, jf. bilag X, punkt 4; hvis EU-typeafprøvningscertifikaterne er udstedt af samme bemyndigede organ, som ansøgningen indsendes til, skal ansøgningen også omfatte en henvisning til den tekniske dokumentation og opdateringer heraf og de udstedte certifikater.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p.
Kvalitetsstyringssystemet skal implementeres på en sådan måde, at det sikres, at det er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet, og med de bestemmelser i denne forordning, der gælder for udstyret i hver fase.
1).
Den pågældende dokumentation skal navnlig indeholde en fyldestgørende beskrivelse af alle de elementer, der er anført i bilag IX, punkt 2.2, litra a), b), d) og e).
ANNEX X
Bilag IX, punkt 2.3, første og andet afsnit, finder anvendelse.
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
Hvis kvalitetsstyringssystemet er et system, som sikrer, at udstyret er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet, og at det er i overensstemmelse med de relevante bestemmelser i denne forordning, skal det bemyndigede organ udstede e EU-certifikat om kvalitetssikring af produktionen.
EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentation and relevant life cycle processes and a corresponding representative sample of the device production envisaged, fulfils the relevant provisions of this Regulation.
Det bemyndigede organ underretter fabrikanten om sin afgørelse om at udstede certifikatet.
Application
Afgørelsen skal indeholde resultaterne af det bemyndigede organs audit og en begrundet vurdering.
The manufacturer shall lodge an application for assessment with a notified body.
Bilag IX, punkt 2.4, finder anvendelse.
the name of the manufacturer and the address of its registered place of business and, if the application is lodged by the authorised representative, the name of the authorised representative and the address of its registered place of business,
Overvågning
the technical documentation referred to in Annexes II and III.
Bilag IX, punkt 3.1, punkt 3.2, første, andet og fjerde led, og punkt 3.3, 3.4, 3.6 og 3.7, finder anvendelse.
The applicant shall make a representative sample of the device production envisaged (‘type’) available to the notified body.
Verifikation af fremstillet udstyr i klasse D
The notified body may request other samples as necessary,
For udstyr i klasse D skal fabrikanten gennemføre test på hver fremstillet batch af udstyr.
in the case of devices for self-testing or near-patient testing, test reports, including results of studies carried out with intended users, and data showing the handling suitability of the device in relation to its intended purpose for self-testing or near patient-testing,
Efter afslutning af kontrollerne og testene skal fabrikanten straks fremsende de relevante rapporter om disse test til det bemyndigede organ.
where practicable, an example of the device.
Fabrikanten skal desuden stille prøver af fremstillede udstyr eller batcher af udstyr til rådighed for det bemyndigede organ i overensstemmelse med på forhånd fastsatte betingelser og nærmere ordninger, som skal omfatte, at det bemyndigede organ eller fabrikanten sender prøver, der er udtaget af de fremstillede udstyr eller batcher af udstyr, til et EU-referencelaboratorium, hvis et sådant laboratorium er blevet udpeget i overensstemmelse med artikel 100, med henblik på gennemførelse af relevante laboratorieprøvninger.
If required, the device shall be returned on completion of the technical documentation assessment;
Fabrikanten eller, hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, dennes autoriserede repræsentant skal i mindst 10 år, efter at det sidste udstyr er bragt i omsætning, kunne forelægge de kompetente myndigheder:
data showing the suitability of the device in relation to its intended purpose for self-testing or near-patient testing,
den i bilag IX, punkt 2.1, femte led, omhandlede dokumentation
the information to be provided with the device on its label and its instructions for use, and
den i bilag IX, punkt 2.1, ottende led, omhandlede dokumentation, herunder EU-typeafprøvningscertifikatet, jf. bilag X
a written declaration that no application has been lodged with any other notified body for the same type, or information about any previous application for the same type that was refused by another notified body or was withdrawn by the manufacturer or its authorised representative before that other notified body made its final assessment.
oplysninger om de i bilag IX, punkt 2.4, omhandlede ændringer og
Assessment
de i bilag IX, punkt 2.3, 3.3 og 3.4, omhandlede afgørelser og rapporter fra det bemyndigede organ.
examine the application, by using staff with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence.
BILAG XII
The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests;
CERTIFIKATER, DER UDSTEDES AF ET BEMYNDIGET ORGAN
examine and assess the technical documentation for conformity with the requirements of this Regulation that are applicable to the device and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable standards referred to in Article 8 or with applicable CS, and record items not designed on the basis of the relevant standards referred to in Article 8 or of the relevant CS;
Certifikater skal udarbejdes på et af EU's officielle sprog.
review the clinical evidence presented by the manufacturer in the performance evaluation report in accordance with Section 1.3.2 of Annex XIII.
Hver attest må kun vedrøre én overensstemmelsesvurderingsprocedure.
The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the clinical application of the device in question for the purposes of that review;
Certifikater udstedes kun til én fabrikant.
in circumstances in which the clinical evidence is partly or totally based on data from devices which are claimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation.
Fabrikantens navn og adresse i certifikatet skal være det/den samme som det navn og den adresse, der er registreret i det elektroniske system, jf. artikel 27.
The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity;
Certifikaters indhold skal utvetydigt beskrive det omfattede udstyr:
clearly document the outcome of its assessment in the performance evaluation assessment report referred to in Section 4.8 of Annex IX;
EU-certifikater for vurdering af teknisk dokumentation og EU-typeafprøvningscertifikater skal indeholde en klar identifikation herunder af udstyrets navn, model og type, det erklærede formål som opført af fabrikanten i brugsanvisningen og i forbindelse med hvilket udstyret er blevet vurderet i overensstemmelsesvurderingsproceduren, risikoklassificering og den grundlæggende UDI-DI, jf. artikel 24, stk. 6.
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements laid down in this Regulation in the event that the standards referred to in Article 8 or the CS have not been applied.
EU-kvalitetsstyringssystemcertifikater og EU-certifikater om kvalitetssikring af produktionen skal indeholde identifikationsoplysninger om udstyr og grupper af udstyr, risikoklassificering og det erklærede formål.
Where the device has to be connected to another device or devices in order to operate as intended, proof shall be provided that it conforms to the general safety and performance requirements when connected to any such device or devices having the characteristics specified by the manufacturer;
Det bemyndigede organ skal på anmodning kunne godtgøre, hvilket (individuelt) udstyr der er omfattet af certifikatet.
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised standards, those standards have actually been applied;
Det bemyndigede organ opretter et system, der gør det muligt at identificere det udstyr, som er omfattet af certifikatet, herunder dets klassificering.
agree with the applicant on the place where the necessary assessments and tests are to be carried out;
Certifikater skal i påkommende tilfælde indeholde en note om, at med henblik på at bringe det udstyr, som den omfatter, i omsætning kræves der et andet certifikat, der udstedes i overensstemmelse med denne forordning.
draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to (g);
EU-kvalitetsstyringssystemcertifikater og EU-certifikater om kvalitetssikring af produktionen for sterilt udstyr i klasse A skal indeholde en erklæring om, at det bemyndigede organs audit var begrænset til de aspekter af fabrikationen, der vedrører sikring og vedligeholdelse af sterile forhold.
in the case of class D devices, request the EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
Hvis et certifikat suppleres, ændres eller genudstedes, skal det nye certifikat indeholde en henvisning til det tidligere certifikat og dets udstedelsesdato med angivelse af ændringerne.
The verification shall include laboratory tests by the EU reference laboratory in accordance with Article 48(5).
CERTIFIKATERS MINIMUMSINDHOLD
In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation, consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 following the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
det bemyndigede organs navn, adresse og identifikationsnummer
The scientific opinion of the EU reference laboratory and, where the procedure laid down in Article 48(6) is applicable, the views of the experts consulted, and any possible updates shall be included in the documentation of the notified body concerning the device.
fabrikantens navn og adresse og, hvis det er relevant, den autoriserede repræsentants navn og adresse
The notified body shall give due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views expressed by the experts consulted in accordance with Article 48(6), when making its decision.
unikt nummer, der identificerer certifikatet
The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable;
fabrikantens SRN, hvis det allerede er udstedt, jf. artikel 28, stk. 2
for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use, of one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as ‘the medicinal products authority consulted’ depending on which has been consulted under this point) on the suitability of the device in relation to the medicinal product concerned.
udstedelsesdato
Where the medicinal product falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMA.
udløbsdato
If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the EMA, that is responsible for the authorisation.
data, der er nødvendige for utvetydigt at kunne identificere udstyret, hvis det er relevant, jf. dette bilags punkt 4
The medicinal products authority consulted shall deliver its opinion within 60 days of receipt of all the necessary documentation.
hvis det er relevant, en henvisning til eventuelle tidligere certifikater, jf. kapitel I, punkt 8
The opinion of the medicinal products authority consulted and any possible update shall be included in the documentation of the notified body concerning the device.
henvisning til denne forordning og til det relevante bilag, i overensstemmelse med hvilket overensstemmelsesvurderingen er foretaget
The notified body shall give due consideration to the opinion expressed by the medicinal products authority consulted when making its decision.
gennemførte undersøgelser og prøvninger, f.eks. henvisning til relevante fælles specifikationer, harmoniserede standarder, prøvningsrapporter og auditrapport(er)
It shall convey its final decision to the medicinal products authority consulted; and
hvis det er relevant, en henvisning til de relevante dele af den tekniske dokumentation eller andre certifikater, der kræves for at bringe det omfattede udstyr i omsætning
draw up an EU type-examination report on the results of the assessments and tests carried out, and scientific opinions provided under, points (a) to (k), including a performance evaluation assessment report for class C or class D devices or covered by the third indent of Section 2.
hvis det er relevant, oplysninger om det bemyndigede organs overvågning
Certificate
konklusionen af det bemyndigede organs overensstemmelsesvurdering for så vidt angår det pågældende bilag
If the type conforms to this Regulation, the notified body shall issue an EU type-examination certificate.