原创力文档MDCG 2022-13 Rev.1 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies（合格评定机构和公告机构的指定、重新评估和通知）.pdf
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MedicalDevices
MedicalDeviceCoordinationGroupDocumentMDCG2022-13Rev.1
applicableforMDR,andIVDR
MDCG2022-13Rev.1
Designation,re-assessment
andnotificationofconformity
assessmentbodiesandnotified
bodies
Revision1–June2024
ThisdocumenthasbeenendorsedbytheMedicalDeviceCoordinationGroup
(MDCG)establishedbyArticle103ofRegulation(EU)2017/745.TheMDCGis
composedofrepresentativesofallMemberStatesanditischairedbya
representativeoftheEuropeanCommission.
ThedocumentisnotaEuropeanCommissiondocumentanditcannotberegarded
asreflectingtheofficialpositionoftheEuropeanCommission.Anyviewsexpressed
inthisdocumentarenotlegallybindingandonlytheCourtofJusticeoftheEuropean
UnioncangivebindinginterpretationsofUnionlaw.
Page1of37
MedicalDevices
MedicalDeviceCoordinationGroupDocumentMDCG2022-13Rev.1
applicableforMDR,andIVDR
MDCG2022-13revision1changes
Updatethedocumenttoincludeguidanceontheconductofjointassessmentsrelatingtoextending
thescopeofdesignations
Contents
1Introductionandscope2
2Designationassessments4
2.1Pre-assessmentandoff-siteactivities4
2.2On-site-assessmentactivities12
2.3Poston-siteassessmentactivities16
2.4Decisionondesignation19
3NotificationandpublicationinNANDO22
3.1NotificationinNANDO22
3.2Contentsofthenotification22
3.3Supportingdocuments23
3.4Objectionperiod23
3.5PublicationinNANDOandvalidityofthedesignation24
4Assessmentsrelatingtoextensionofthescopeofthedesignation24
4.1Pre-assessmentandoff-site
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