medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
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Category: Vigilance

Ceci n’est pas une période de transition and first reaction to the Implant Files

Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

New EU guidance on medical devices vigilance reporting – more than meets the eye

Update on Eudamed and its implications for vigilance in the EU

New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

EU court rules on no-fault liability for medical services with medical devices

Outlines of the medical devices Recast become more fixed with Council conclusions

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  • Medicaldeviceslegal tweets

    • New #MDCG guidance on temporary extraordinary measures related to medical device #NotifiedBody #audits during… twitter.com/i/web/status/1… 6 hours ago
    • #MDR amendment proposal article 120 (3) oversight set to be fixed #medicaldevices #postponement #medtech #EUMDR… twitter.com/i/web/status/1… 14 hours ago
    • The #MDR amendment proposal to move date of application by a year: more than meets the eye #medicaldevices #medtech… twitter.com/i/web/status/1… 4 days ago
    • Commission working on proposal to postpone #MDR date of application for one year #medicaldevices #medtech #eumdr medicaldeviceslegal.com/?p=6801 2 weeks ago
    • The #MDCG guidance on significant changes - a significant change? #medicaldevices #eumdr #medtech #MDR #IVDR… twitter.com/i/web/status/1… 2 weeks ago
    • The #MDR and the #Covid-19 recommendation - a possible template for fixing the MDR and #IVDR bottleneck… twitter.com/i/web/status/1… 2 weeks ago
    • New #MDCG Class I Article 120 (3) and (4) #MDR guidance - nothing new but nice summary of requirements… twitter.com/i/web/status/1… 3 weeks ago
    • The #MDCG #cybersecurity guidance - a helpful rush job #medicaldevices #ehealth #mhealth #medtech #euMDR #MDR #IVDR… twitter.com/i/web/status/1… 3 weeks ago
    • The #MDCG MDR joint implementation plan for the #MDR (not the #IVDR) #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 3 weeks ago
    • #Brexit is a fact - now deal with it And what does that mean for #medicaldevices for the coming years?… twitter.com/i/web/status/1… 2 months ago

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