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dc.contributor.authorBretthauer, Michael
dc.contributor.authorGerke, Sara
dc.contributor.authorHassan, Cesare
dc.contributor.authorAhmad, Omer F.
dc.contributor.authorMori, Yuichi
dc.date.accessioned2024-03-08T14:31:10Z
dc.date.available2024-03-08T14:31:10Z
dc.date.issued2023-04-18
dc.description.abstractThe European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveillance of benefits and harms to the entire life cycle of devices. New “expert panels” have been established by the European Commission to advise in the assessment of devices toward certification, and the role of previous “notified bodies” (private companies charged by the Commission with ensuring that manufacturers follow the requirements for device testing) is being expanded. The MDR does not contain a grandfathering clause; thus, all existing medical devices must be recertified under the stricter regulation. The recertification deadline has recently been extended to 2027 or 2028, depending on the device's risk class. Whether most device manufacturers can meet these new requirements is uncertain, and the MDR will likely have important consequences for manufacturers, researchers, clinicians, and patients. Enhanced collaborations between the medical device industry and physician partners will be needed to meet the new requirements in a timely manner to avoid shortages of existing devices and to mitigate barriers to development of new devices.en_US
dc.identifier.citationBretthauer, Gerke, Hassan, Ahmad, Mori. The New European Medical Device Regulation: Balancing Innovation and Patient Safety. Annals of Internal Medicine. 2023;176(6):844-848en_US
dc.identifier.cristinIDFRIDAID 2169078
dc.identifier.doi10.7326/M23-0454
dc.identifier.issn0003-4819
dc.identifier.issn1539-3704
dc.identifier.urihttps://hdl.handle.net/10037/33145
dc.language.isoengen_US
dc.publisherAmerican College of Physiciansen_US
dc.relation.journalAnnals of Internal Medicine
dc.relation.projectIDinfo:eu-repo/grantAgreement/EC/Horizon 2.1./101057099/Norway/OPTIMISING COLORECTAL CANCER PREVENTION TROUGH PERSONALISED TREATMENT WITH ARTIFICIAL INTELLIGENCE/OperA/en_US
dc.relation.projectIDinfo:eu-repo/grantAgreement/EC/Horizon 2.1/101057321/Ireland/VALIDATING AI IN CLASSIFYING CANCER IN REAL-TIME SURGERY/CLASSICA/en_US
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.titleThe New European Medical Device Regulation: Balancing Innovation and Patient Safetyen_US
dc.type.versionacceptedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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