Transcription of MEDICAL DEVICE REGULATION (MDR) - GS1
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MEDICAL DEVICE REGULATION (MDR)EUROPEV olker Zeinar07 Nov 2019 - GS1 Healthcare Conference, New Braun Melsungen AG 3EU REGULATION MDR 2017 / 745 ChapterSubjectIScope / DefinitionsIIMaking available +putting into service, obligations economic operators, reprocessing, CE marking, ..IIII dentification,traceability, registration of economic operators + devices , EUDAMED, ..IVNotified BodiesVClassification / conformity assessmentVIClinical evaluation/ investigationVIIPost-market surveillance, vigilance, market surveillanceVIIIC ooperationbetween MS, Med Dev Coord. Group, expert panels, ..IXConfidentiality, data protection, funding, penaltiesXFinal provisionsAnxSubjectIGeneralsafety + performance requirementsIITechnical + chapters - 123 articles - 17 annexes175 pages - replaces the MDD 93/42/ECKEY DATESMDR Publication 05 May 2017 Entry into force 26 May 2017 Date of Appl. 26 May 2020 Transition Period 26 May 2024S C O P Eall MEDICAL DevicesExcept :Custom-made devB.
MEDICAL DEVICE REGULATION (MDR). EUROPE. Volker Zeinar. 07 Nov 2019 - GS1 Healthcare Conference, New Delhi
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