natgillin/translations-raw huggingface dataset:
dokumentere ansvarsområder og mekanismer for meddelelse af beslutninger klart, navnlig såfremt den endelige underskriver af et certifikat adskiller sig fra beslutningstageren eller beslutningstagerne eller ikke opfylder de krav, der er fastlagt i punkt 3.2.7
For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX, notified bodies shall have sufficient expertise, facilities and documented procedures for:
udstede et certifikat eller certifikater i overensstemmelse med mindstekravene i bilag XII med en gyldighedsperiode på højst fem år og angive, om der gælder særlige betingelser eller begrænsninger i forbindelse med certificeringen
the allocation of appropriately qualified and authorised personnel for the examination of individual aspects, such as use of the device, biocompatibility, performance evaluation, risk management and sterilisation, and
udstede et certifikat eller certifikater udelukkende til ansøgeren og ikke at udstede certifikater, der dækker flere enheder
the assessment of conformity of the design with this Regulation, and taking account of Sections 4.5.4. and 4.5.5.
sikre, at fabrikanten underrettes om resultatet af vurderingen og den heraf følgende beslutning, og at de indlæses i det elektroniske system, der er nævnt i artikel 52.
This assessment shall include the examination of the implementation by manufacturers of incoming, in-process and final checks and the results thereof.
Ændringer
If further tests or other evidence is required for the assessment of conformity with the requirements of this Regulation, the notified body in question shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests.
Det bemyndigede organ skal have indført dokumenterede procedurer og kontraktlige aftaler med fabrikanter vedrørende fabrikanters oplysningskrav og vurdering af ændringer af:
Type-examinations
det eller de godkendte kvalitetsstyringssystemer eller det omfang af produkter, der er omfattet
The notified body shall have documented procedures, sufficient expertise and facilities for the type-examination of devices in accordance with Annex X including the capacity to:
den godkendte design af udstyr
examine and assess the technical documentation, taking account of Sections 4.5.4. and 4.5.5, and verify that the type has been manufactured in conformity with that documentation;
den godkendte udstyrstype
establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility;
ethvert stof, der indgår i eller benyttes til fremstilling af udstyr, og som er underlagt specifikke procedurer i overensstemmelse med punkt 4.5.5.
document its rationale for the selection of those parameters;
Procedurerne og de kontraktlige aftaler, der er omhandlet i første afsnit, skal omfatte foranstaltninger til kontrol af betydningen af de ændringer, der er omhandlet i første afsnit.
carry out the appropriate examinations and tests in order to verify that the solutions adopted by the manufacturer meet the general safety and performance requirements set out in Annex I. Such examinations and tests shall include all tests necessary to verify that the manufacturer has in fact applied the relevant standards it has opted to use;
Det pågældende bemyndigede organ skal i overensstemmelse med sine dokumenterede procedurer:
agree with the applicant as to where the necessary tests will be performed if they are not to be carried out directly by the notified body;
sikre, at fabrikanter indsender planer om ændringer som omhandlet i første afsnit til forhåndsgodkendelse og relevante oplysninger vedrørende sådanne ændringer
assume full responsibility for test results.
vurdere de foreslåede ændringer og verificere, om kvalitetsstyringssystemet eller udstyrets eller udstyrstypens design efter disse ændringer fortsat opfylder kravene i denne forordning
Test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer.
underrette fabrikanten om sin afgørelse og forelægge en rapport eller, hvis det er relevant, en tillægsrapport, der skal indeholde de begrundede konklusioner fra dets vurdering.
Verification by examination and testing of every product batch
Overvågningsaktiviteter og tilsyn efter certificering
The notified body shall:
Det bemyndigede organ skal have dokumenterede procedurer:
have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product batch in accordance with Annexes IX and XI;
der fastlægger, hvordan og hvornår der skal udføres overvågningsaktiviteter vedrørende fabrikanter.
establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility in order to:
Disse procedurer skal indeholde foranstaltninger vedrørende uanmeldte audit på stedet hos fabrikanter og, hvis det er relevant, underentreprenører og leverandører, som udfører produktprøvninger, og tilsyn med opfyldelse af eventuelle betingelser, som fabrikanter er bundet af, og som har forbindelse med certificeringsafgørelser, f.eks. opdateringer af kliniske data med bestemte mellemrum
verify, for class C devices, the conformity of the device with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to those devices,
til gennemgang af relevante kilder til videnskabelige og kliniske oplysninger og oplysninger forelagt, efter at udstyr er bragt i omsætning, vedrørende omfanget af deres udpegelse.
confirm, for class B devices, the conformity with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to those devices,
Disse oplysninger skal tages i betragtning i forbindelse med planlægning og udførelse af overvågningsaktiviteter
document its rationale for the selection of the parameters referred to in point (b);
med henblik på at gennemgå sikkerhedsovervågningsoplysninger, som de har adgang til i henhold til artikel 87, for at vurdere deres eventuelle indvirkning på gyldigheden af gældende certifikater.
have documented procedures to carry out the appropriate assessments and tests in order to verify the conformity of the device with the requirements of this Regulation by examining and testing every product batch as specified in Section 5 of Annex XI;
ikke at træffe foranstaltninger på det grundlag, at sikkerhedsovervågningssagen klart ikke er knyttet til den tildelte certificering
Performance evaluation assessment
observere fabrikantens og de kompetente myndigheders aktiviteter og resultaterne af fabrikantens undersøgelse med henblik på at afgøre, om den tildelte certificeringer i fare, eller om passende korrigerende handlinger er foretaget
The assessment by notified bodies of procedures and documentation shall address the results of literature searches and all validation, verification and testing performed and conclusions drawn, and shall typically include considering the use of alternative materials and substances and take account of the packaging, stability including shelf life of the finished device.
gennemføre ekstraordinære overvågningsforanstaltninger, f.eks. dokumentgennemgang, audit med kort varsel eller uanmeldte audit og produktprøvning, såfremt det er sandsynligt, at den tildelte certificeringer i fare
Where no new testing has been undertaken by a manufacturer or where there have been deviations from procedures, the notified body in question shall critically examine the justification presented by the manufacturer.
forøge hyppigheden af overvågningsaudit
The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to performance evaluation both for initial conformity assessment and on an ongoing basis.
gennemgå specifikke produkter eller processer i forbindelse med den næste audit af fabrikanten eller
The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address:
træffe alle andre relevante foranstaltninger.
the planning, conduct, assessment, reporting and updating of the performance evaluation as referred to in Annex XIII,
I forbindelse med overvågningsaudit af fabrikanter skal det bemyndigede organ have dokumenterede procedurer til at:
post-market surveillance and post-market performance follow up,
foretage overvågningsaudit af fabrikanten mindst en gang om året, hvilket planlægges og foretages i overensstemmelse med de relevante krav i punkt 4.5
the interface with the risk management process,
sikre, at den foretager en tilstrækkelig vurdering af fabrikantens dokumentation om og anvendelse af bestemmelserne om sikkerhedsovervågning, overvågning, efter at udstyret er bragt i omsætning, og PMPF
the appraisal and analysis of the available data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I,
udtage stikprøver af og afprøve udstyr og teknisk dokumentation under audit i henhold til foruddefinerede prøveudtagningskriterier og prøvningsprocedurer for at sikre, at fabrikanten løbende anvender det godkendte kvalitetsstyringssystem
the conclusions drawn with regard to the clinical evidence and drawing up of the performance evaluation report.
sikre, at fabrikanten opfylder de dokumentations- og oplysningskrav, der er fastsat i de relevante bilag, og at dens procedurer tager hensyn til bedste praksis i forbindelse med gennemførelse af kvalitetsstyringssystemer
The procedures referred to in the second paragraph shall take into consideration available CS, guidance and best practice documents.
sikre, at fabrikanten ikke bruger godkendelser af kvalitetsstyringssystemer eller udstyr på en vildledende måde
The notified body's assessment of performance evaluations as referred to in Annex XIII shall cover:
indhente tilstrækkelige oplysninger til at fastslå, om kvalitetsstyringssystemet fortsat opfylder kravene i denne forordning
the intended use specified by the manufacturer and claims for the device defined by it,
anmode den pågældende fabrikant om at foretage korrektioner, korrigerende handlinger og, hvis det er relevant, forebyggende foranstaltninger ved opdagelse af mangler, og
the planning of the performance evaluation,
hvis det er nødvendigt, pålægge særlige restriktioner for det relevante certifikat eller suspendere eller tilbagekalde det.
the methodology for the literature search,
Det bemyndigede organ skal, hvis det er angivet som en del af betingelserne for certificering:
relevant documentation from the literature search,
foretage en tilbundsgående gennemgang af den evaluering af ydeevne, der senest er opdateret af fabrikanten, på grundlag af fabrikantens overvågning, efter at udstyret er bragt i omsætning, på grundlag af dens PMPF og på grundlag af klinisk litteratur, der er relevant for den tilstand, der behandles med udstyret, eller på klinisk litteratur, der er relevant for tilsvarende udstyr
the performance studies,
klart dokumentere resultatet af den tilbundsgående gennemgang og henvende sig til fabrikanten med eventuelle specifikke betænkeligheder eller pålægge denne særlige betingelser
validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability and conclusions data from equivalent and similar devices,
sikre, at den ydeevneevaluering, der senest er opdateret, er korrekt afspejlet i brugsanvisningen og, hvis det er relevant, sammenfatningen af sikkerhed og ydeevne.
the performance evaluation report,
Fornyet certificering
justifications in relation to non-performance of performance studies or PMPF.
Det bemyndigede organ skal have indført dokumenterede procedurer for gennemgang i forbindelse med fornyet certificering og fornyelse af certifikater.
In relation to data from performance studies included within the performance evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved performance study plan.
Fornyet certificering af godkendte kvalitetsstyringssystemer eller EU-vurderingscertifikater for teknisk dokumentation eller EU-typeafprøvningscertifikater skal finde sted mindst hvert femte år.
The notified body shall ensure that the performance evaluation adequately addresses the relevant safety and performance requirements provided for in Annex I, that it is appropriately aligned with the risk management requirements and that it is conducted in accordance with Annex XIII and that it is appropriately reflected in the information provided relating to the device.
Det bemyndigede organ skal have dokumenterede procedurer for fornyelse af EU-vurderingscertifikater for teknisk dokumentation og EU-typeafprøvningscertifikater, og disse procedurer skal kræve, at den pågældende fabrikant indsender en sammenfatning af ændringer og videnskabelige resultater for udstyret, herunder:
Specific Procedures
alle ændringer af det oprindeligt godkendte udstyr, herunder ændringer, hvorom der endnu ikke er underrettet
The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to in Section 5 of Annex IX, for which they are designated.
erfaringer fra overvågning, efter at udstyret er bragt i omsætning
In the case of companion diagnostics, the notified body shall have documented procedures in place that aim to fulfil the requirements of this Regulation in relation to consultation of the EMA or a medicinal products competent authority during its assessment of such types of device.
erfaringer fra risikostyring
Reporting
erfaringer fra opdatering af dokumentationen for opfyldelse af de generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I
ensure that all steps of the conformity assessment are documented so that the conclusions of the assessment are clear and demonstrate compliance with the requirements of this Regulation and can represent objective evidence of such compliance to persons that are not themselves involved in the assessment, for example personnel in designating authorities,
erfaringer fra gennemgange af ydeevneevaluering, herunder resultaterne af eventuelle undersøgelser af ydeevne og PMPF
ensure that records that are sufficient to provide a discernible audit trail are available for quality management system audits,
ændringer af kravene, dele af udstyret eller det videnskabelige eller reguleringsmæssige miljø
clearly document the conclusions of its assessment of performance evaluation in a performance evaluation assessment report,
ændringer af anvendte eller nye harmoniserede standarder, fælles specifikationer eller tilsvarende dokumenter, og
for each specific project, provide a detailed report which shall be based on a standard format containing a minimum set of elements determined by the MDCG.
ændringer inden for medicinsk, videnskabelig og teknisk viden, såsom:
The report of the notified body shall:
nye behandlinger
clearly document the outcome of its assessment and draw clear conclusions from the verification of the manufacturer's conformity with the requirements of this Regulation,
ændringer i testmetoder
make a recommendation for a final review and for a final decision to be taken by the notified body; this recommendation shall be signed off by the member of personnel responsible in the notified body,
nye videnskabelige resultater vedrørende materialer og komponenter, herunder resultater vedrørende deres bioforligelighed
be provided to the manufacturer in question.
erfaringer fra undersøgelser af sammenligneligt udstyr
Final review
data fra registre
The notified body shall prior to making a final decision:
erfaringer fra undersøgelser af ydeevne med sammenligneligt udstyr.
ensure that the personnel assigned for the final review and decision making on specific projects are appropriately authorised and are different from the personnel who have conducted the assessments,
Det bemyndigede organ skal have dokumenterede procedurer til at vurdere de oplysninger, der er omhandlet i andet afsnit, og skal være særligt opmærksom på kliniske data fra overvågning, efter at udstyret er bragt i omsætning, og PMPF-aktiviteter siden den foregående certificering eller fornyede certificering, herunder passende opdateringer af fabrikanters rapporter af ydeevneevaluering.
verify that the report or reports and supporting documentation needed for decision making, including concerning resolution of non-conformities noted during assessment, are complete and sufficient with respect to the scope of the application, and
For så vidt angår afgørelsen om fornyet certificering skal det pågældende bemyndigede organ anvende de samme metoder og principper som i forbindelse med den oprindelige certificeringsafgørelse.
verify whether there are any unresolved non-conformities preventing issuance of a certificate.
Om nødvendigt skal der udarbejdes særskilte formularer til fornyet certificering under hensyntagen til de trin, der skal gennemgås med henblik på certificering, såsom ansøgning og ansøgningsgennemgang.
Decisions and certifications
BILAG VIII
The notified body shall have documented procedures for decision-making including as regards the allocation of responsibilities for the issuance, suspension, restriction and withdrawal of certificates.
KLASSIFICERINGSREGLER
Those procedures shall include the notification requirements laid down in Chapter V of this Regulation.
GENNEMFØRELSESREGLER
The procedures shall allow the notified body in question to:
Klassificeringsreglernes anvendelse er afhængig af udstyrs erklærede formål.
decide, based on the assessment documentation and additional information available whether the requirements of this Regulation are fulfilled,
Hvis det pågældende udstyr er bestemt til at skulle anvendes sammen med andet udstyr, gælder klassificeringsreglerne særskilt for hvert udstyr.
decide, based on the results of its assessment of the performance evaluation and risk management whether the post-market surveillance plan, including the PMPF plan, is adequate,
Tilbehør til medicinsk udstyr til in vitro-diagnostik klassificeres selvstændigt og adskilt fra det udstyr, sammen med hvilket det anvendes.
decide on specific milestones for further review by the notified body of the up to date performance evaluation,
Software, som styrer udstyr eller påvirker anvendelsen af udstyr, henhører under samme klasse som det pågældende udstyr.
decide whether specific conditions or provisions need to be defined for the certification,
Hvis softwaren er uafhængig af andet udstyr, klassificeres den selvstændigt.
decide, based on the novelty, risk classification, performance evaluation and conclusions from the risk analysis of the device, on a period of certification not exceeding five years,
Kalibratorer, der er beregnet til brug sammen med et udstyr, klassificeres i samme klasse som udstyret.
clearly document decision making and approval steps including approval by signature of the members of personnel responsible,
Kontrolmaterialer med kvantitative eller kvalitative fastsatte værdier, der er beregnet til brug med en specifik analyt eller en række analytter, klassificeres i samme klasse som udstyret.
clearly document responsibilities and mechanisms for communication of decisions, in particular, where the final signatory of a certificate differs from the decision maker or decision makers or does not fulfil the requirements laid down in Section 3.2.7.,
For at kunne foretage en korrekt klassificering af udstyr skal en fabrikant tage hensyn til alle klassificering- og implementeringsregler.
issue a certificate or certificates in accordance with the minimum requirements laid down in Annex XII for a period of validity not exceeding five years and shall indicate whether there are specific conditions or limitations associated with the certification,
Hvis en fabrikant angiver, at et udstyr har flere erklærede formål, og udstyret som følge heraf henhører under mere end én klasse, skal det klassificeres i den højeste klasse.
issue a certificate or certificates for the applicant alone and shall not issue certificates covering multiple entities,
Hvis flere klassificeringsregler finder anvendelse på samme udstyr, finder reglen om placering i den højeste klasse anvendelse.
ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that they are entered into the electronic system referred to in Article 52.
Hver klassificeringsregel finder anvendelse på indledende test, konfirmatoriske test og supplerende test.
Changes and modifications
Regel 1
The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to the manufacturers' information obligations and the assessment of changes to:
Udstyr, der skal anvendes til følgende formål klassificeres i klasse D:
the approved quality management system or systems or to the product-range covered,
påvisning af tilstedeværelse af eller eksponering for overførbare agenser i blod, blodkomponenter, celler, væv eller organer eller i derivater heraf for at vurdere deres egnethed til transfusion, transplantation eller indgift af celler
the approved design of a device,
påvisning af tilstedeværelse af eller eksponering for overførbare agenser, som forårsager livstruende sygdomme med en høj eller formodet høj risiko for spredning
the approved type of a device,
fastlæggelse af en smittefarlig koncentration af en livstruende sygdom, hvis monitorering er afgørende for patientbehandlingsprocessen.
any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.5.
Regel 2
The procedures and contractual arrangements referred to in the first paragraph shall include measures for checking the significance of the changes referred to in the first paragraph.
Udstyr, der skal anvendes til blodtypebestemmelse eller vævstypebestemmelse for at sikre immunologisk kompatibilitet af blod, blodkomponenter, celler, væv eller organer, der skal anvendes til transfusion eller transplantation eller indgift af celler, klassificeres i klasse C, medmindre det skal anvendes til bestemmelse af en eller flere af følgende markører:
In accordance with its documented procedures, the notified body in question shall:
systemet [A (AB01), B (AB02), AB (AB03)]
ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and relevant information relating to such changes,
rhesussystemet [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]
assess the changes proposed and verify whether, after these changes, the quality management system, or the design of a device or type of a device, still meets the requirements of this Regulation,
Kellsystemet [Kel1 (K)]
notify the manufacturer of its decision and provide a report or, as applicable, a supplementary report, which shall contain the justified conclusions of its assessment.
Kiddsystemet [JK1 (Jka), JK2 (Jkb)]
Surveillance activities and post-certification monitoring
Duffysystemet [FY1 (Fya), FY2 (Fyb)],
The notified body shall have documented procedures:
idet de i så fald klassificeres i klasse D.
defining how and when surveillance activities of manufacturers are to be conducted.
Regel 3
Those procedures shall include arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at defined intervals,
Udstyr klassificeres i klasse C, hvis det er beregnet til:
for screening relevant sources of scientific and clinical data and post-market information relating to the scope of their designation.
påvisning af tilstedeværelse af eller eksponering for en seksuelt overført agens
Such information shall be taken into account in the planning and conduct of surveillance activities,