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

Eudamed enters into full force

  • Erik Vollebregt

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  • Medicaldeviceslegal tweets

    • Finally remote initial audits under the #MDR and #IVDR, or not (yet)? #medtech #diagnostics #IVDs #medicaldevices medicaldeviceslegal.com/2021/01/24/fin… 1 month ago
    • Outlook for EU #medicaldevices and #IVD regulation for 2021 - and happy new year! #medtech #eumdr #diagnostics… twitter.com/i/web/status/1… 2 months ago
    • The #Brexit ‘deal’ has finally dropped - what’s in it for the #medicaldevices industry? #MDR #IVDR #medtech #eudmr… twitter.com/i/web/status/1… 2 months ago
    • The EU Court's Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required… twitter.com/i/web/status/1… 7 months ago
    • #Standardisation request for #MDR and #IVDR refused - now what? #medicaldevices #medtech #eumdr #diagnostics #IVDs medicaldeviceslegal.com/2020/06/20/sta… 8 months ago
    • The urgency with #IVDs under the EU #IVDR #medicaldevices #medtech #dx #diagnostics #invitrodiagnostics medicaldeviceslegal.com/2020/06/08/the… 8 months ago
    • EU #MDR: where are we at Date of Entry into Force plus three years and a little bit? #medicaldevices #IVDs… twitter.com/i/web/status/1… 8 months ago
    • EU #MDR date of application move: politically a done deal now #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 10 months ago
    • New #MDCG guidance on temporary extraordinary measures related to medical device #NotifiedBody #audits during… twitter.com/i/web/status/1… 10 months ago
    • #MDR amendment proposal article 120 (3) oversight set to be fixed #medicaldevices #postponement #medtech #EUMDR… twitter.com/i/web/status/1… 10 months ago

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