medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

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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  • Erik Vollebregt

    Erik is a founding partner of the boutique life sciences law firm Axon Lawyers and specialised in EU legal and regulatory issues relating to medical technology

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  • Medicaldeviceslegal tweets

    • Welcome to 2020 - year of the proof of the MDR pudding #medicaldevices #MDR #medtech medicaldeviceslegal.com/2020/01/13/wel… https://t.co/lLMM4h8CMt 2 weeks ago
    • A not so happy #MDR and #IVDR Christmas Carol #medtech #eumdr #medicaldevices medicaldeviceslegal.com/2019/12/25/a-n… https://t.co/GNyRDJ5TcF 1 month ago
    • More on the #PRRC under new EU #medicaldevices regulations #MDR #IVDR medicaldeviceslegal.com/2019/12/12/mor… 1 month ago
    • The Commission and the Council on the #MDR state of affairs #medicaldevices #medtech #eumdr medicaldeviceslegal.com/2019/12/10/the… https://t.co/coF7fV5s3Y 1 month ago
    • #Corrigendum 2 to the EU #MDR and the (potential) consequences for class I #medicaldevices #medtech… twitter.com/i/web/status/1… 1 month ago
    • #Eudamed delayed, but #MDR not delayed - now what? #medicaldevices #medtech #IVDR medicaldeviceslegal.com/2019/11/19/eud… https://t.co/kZQblUstOU 1 month ago
    • Counting down to the #MDR date of application, and the legal stuff to get right before end May 2020 #medicaldevices… twitter.com/i/web/status/1… 3 months ago
    • New sort of applicable economic operators regulation for medical devices in the EU: the Market Surveillance Regulat… twitter.com/i/web/status/1… 5 months ago
    • € 500 per data subject in immaterial damages - a quantification of why #GDPR matters #dataprotection #cybersecurity… twitter.com/i/web/status/1… 6 months ago
    • Qserve / Axon EU #MDR and #IVDR pop-up conference in Boston MA on 18 July #medicaldevices #invitrodiagnostics #IVDs… twitter.com/i/web/status/1… 6 months ago

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