应对紧迫MDR挑战的解决方案

Sponsored byMatthias Fink, M.D., AKRA TeamSolutions to Your Pressing MDR ChallengesThispresentationisintendedforeducationalpurposes onlyanddoesnotreplacethelegaltextofthe legislation,standardsorguidancedocuments.Therequirementsonnotifiedbodieswillbeusedto shareexperience.Notifiedbodynamesordetailsare notincluded.AKRATEAMshouldnotmadeliablefordifferent opinionsorinterpretationsofCompetentAuthorities, NotifiedBodies,ConformityAssessmentBodiesorany otherrelevantorganizations.Disclaimerwww.akrateam.com| 2Copyright©AKRATEAM.Donotdistribute.Extensionofthetransitionalperiodin Art.120(3)•donotpresentanyunacceptablerisktohealthand safety•havenotundergonesignificantchangesindesignor intendedpurposeAND•forwhichthemanufacturershavealreadyundertakenthenecessarystepstolaunchthecertificationprocess undertheMDR•AdaptationofQMStoMDR•ApplicationforconformityassessmentbyaNB beforeacertaindeadlineExtensionofTransition ProvisionsperMDRArt.120Regulation2023/60715March2023AppliesonlytodevicesthatImplementati