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Oct 2023

Draft EUDAMED Roadmap of Modules

Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.

leoeisner October 21, 2023October 21, 2023 13485, 14971, 15223-1, 60601 Amendments, 60601 Series, 60601-1, 60601-1 A2, 60601-1 Amendment 2, 60601-1-10, 60601-1-11, 60601-1-12, 60601-1-2, 60601-1-2, 4th ed., 60601-1-6, 60601-1-8, 60601-1-9, 62304, 62366, 62366-1, Active Implants, Auditing, Combination Product, Cybersecurity, Device, EMC, Essential Performance, EU, EU Commission, EUDAMED, ISO 15223-1, IVDR, Labeling, Marking, MDCG, MDR, Medical Device, Medical Device Regulation, Notified Bodies, Oct 2023, Regulation, State of the Art, UDI Read more

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Categories – Hot Topics

510(k) 60601 series 60601-1 60601-1 3rd ed. A1 AAMI AAMI ES60601-1 AAMI ES60601-1/C1 Active Implantable Medical Devices Directive AIMDD Amendment 1 ANSI/AAMI ES60601-1 CDRH CENELEC Collateral Standard EN60601 EN60601-1 ESCNews EU European Commission FDA FDA Guidance Health Canada Home Healthcare Environments Home Use Home Use Environment Home Use Med Dvcs IEC IEC 60601-1 IEC60601-1 IEC60601-1 3rd ed. IEC60601-1-11 ISO 14971 IVD IVDD MDD MDD Amendment Medical Medical Device Medical Device Directive Medical Device Industry Medical Device Regulatory Medical Devices Notified Body Risk Management

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