medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
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Tag browsing: notified bodies

Festive alert! Change is on its way.

In the mean time: a Staff Working Document

Surprise! Unannounced notified body audits Commission recommendation finally issued

ENVI’s 29 may debate on medical devices

Unannounced notified body visits recommendation imminent – amend your contracts and procedures now!

Fireworks! Or a disappointing dud? The 26 February ENVI workshop on the EU medical devices and IVD proposals

“U” is for unannounced audits – what’s up with those?

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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

    • National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 1 week ago
    • IVDR, in-house developed tests and the state of MDR/IVDR implementation medicaldeviceslegal.com/2019/05/12/ivd… https://t.co/E4x5ZJGzYf 1 week 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… 1 month ago
    • What to expect for 2019 with EU #MDR and #IVDR implementation? #medicaldevices #ivds #medtech #invitrodiagnostics… twitter.com/i/web/status/1… 2 months ago
    • Don't give me #Brexit problems, give me Brexit scenarios #medicaldevices #IVDs #medtech #CEcertificates #CEmarking… twitter.com/i/web/status/1… 3 months ago
    • First notified body for EU MDR designated! #MDR #IVDR #medtech #medicaldevices medicaldeviceslegal.com/2019/01/21/fir… https://t.co/X46AeuHftM 4 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… 4 months ago
    • Ceci n'est pas une période de transition and first reaction to the #ImplantFiles - #mdr #ivdr #medicaldevices… twitter.com/i/web/status/1… 5 months ago
    • #MDR / #IVDR Implementation: the transition period for the EU medical devices regulations at the halfway point semi… twitter.com/i/web/status/1… 7 months ago
    • Bottlenecks, #Brexit and stalling CAMD roll-out - a new post on #MDR and #IVDR implementation #medicaldevices… twitter.com/i/web/status/1… 9 months ago

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