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

    • The implementation of the new EU #MDR and # IVDR in 2019: up or out, sink or swim #medicaldevices #ivds #medtech… twitter.com/i/web/status/1… 1 week ago
    • Ceci n'est pas une période de transition and first reaction to the #ImplantFiles - #mdr #ivdr #medicaldevices… twitter.com/i/web/status/1… 1 month ago
    • #MDR / #IVDR Implementation: the transition period for the EU medical devices regulations at the halfway point semi… twitter.com/i/web/status/1… 3 months ago
    • Bottlenecks, #Brexit and stalling CAMD roll-out - a new post on #MDR and #IVDR implementation #medicaldevices… twitter.com/i/web/status/1… 5 months ago
    • #IVDR and #MDR implementation seminar on 18 May at @axonlawyers #medicaldevices #ivds medicaldeviceslegal.com/2018/04/12/ivd… https://t.co/3q4PQNRr2d 9 months ago
    • #MDR & #IVDR update after the first MDCG/stakeholders meeting and an IVD seminar at Axon Lawyers #medicaldevices… twitter.com/i/web/status/9… 9 months ago
    • An EU Court #medicaldevices #software qualification case with a twist #samd #mdr #MEDDEV medicaldeviceslegal.com/2018/01/12/an-… 1 year ago
    • Happy New Year - with the EU #MDR transition period going past halfway point #medicaldevices medicaldeviceslegal.com/2018/01/08/hap… https://t.co/PaXZpKHZza 1 year ago
    • RT @IVDAust: @MedDevLegal Australian IVD Companies may also be affected by this... 1 year ago
    • The notified body bottleneck in implementing EU #MDR and #IVDR becoming a problem for #medicaldevices manufacturers medtech.pharmaintelligence.informa.com/MT121869/Exper… 1 year ago

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