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

    • Qserve / Axon EU #MDR and #IVDR pop-up conference in Boston MA on 18 July #medicaldevices #invitrodiagnostics #IVDs… twitter.com/i/web/status/1… 2 weeks ago
    • 'Person responsible for regulatory compliance" #PRRC guidance under EU #MDR and #IVDR published #medicaldevices… twitter.com/i/web/status/1… 3 weeks ago
    • Bottleneck of bottlenecks for #notifiedbody capacity under EU #medicaldevices law #mdr #ivdr medicaldeviceslegal.com/2019/06/13/bot… https://t.co/McscK8wqPU 1 month ago
    • National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 2 months ago
    • IVDR, in-house developed tests and the state of MDR/IVDR implementation medicaldeviceslegal.com/2019/05/12/ivd… https://t.co/E4x5ZJGzYf 2 months ago
    • This was not the Corrigendum you were looking for, more #MDCG guidance on #scrutiny and national #Brexit exemption… twitter.com/i/web/status/1… 3 months ago
    • What to expect for 2019 with EU #MDR and #IVDR implementation? #medicaldevices #ivds #medtech #invitrodiagnostics… twitter.com/i/web/status/1… 4 months ago
    • Don't give me #Brexit problems, give me Brexit scenarios #medicaldevices #IVDs #medtech #CEcertificates #CEmarking… twitter.com/i/web/status/1… 4 months ago
    • First notified body for EU MDR designated! #MDR #IVDR #medtech #medicaldevices medicaldeviceslegal.com/2019/01/21/fir… https://t.co/X46AeuHftM 6 months ago
    • 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… 6 months ago

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  • Recent comments

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    Accessories Advertising Borderline Brexit Business compliance CE marking Clinical evaluation Clinical investigation Data Protection e-commerce eHealth FCPA Intellectual property In Vitro Diagnostics Labeling M&A mHealth Notified Body Patents Personal data Placing on the market PMS Product liability Quality system Recast Scrutiny Software Standards Uncategorized Vigilance

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