medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
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Category: Audits

Surprise! Unannounced notified body audits Commission recommendation finally issued

In the mean time… joint immediate action plan, unannounced audits and other things over the summer

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

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

  • 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

    • 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 weeks ago
    • New sort of applicable economic operators regulation for medical devices in the EU: the Market Surveillance Regulat… twitter.com/i/web/status/1… 3 months ago
    • € 500 per data subject in immaterial damages - a quantification of why #GDPR matters #dataprotection #cybersecurity… twitter.com/i/web/status/1… 3 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… 4 months ago
    • 'Person responsible for regulatory compliance" #PRRC guidance under EU #MDR and #IVDR published #medicaldevices… twitter.com/i/web/status/1… 4 months ago
    • Bottleneck of bottlenecks for #notifiedbody capacity under EU #medicaldevices law #mdr #ivdr medicaldeviceslegal.com/2019/06/13/bot… https://t.co/McscK8wqPU 5 months ago
    • National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 6 months ago
    • IVDR, in-house developed tests and the state of MDR/IVDR implementation medicaldeviceslegal.com/2019/05/12/ivd… https://t.co/E4x5ZJGzYf 6 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… 7 months ago
    • What to expect for 2019 with EU #MDR and #IVDR implementation? #medicaldevices #ivds #medtech #invitrodiagnostics… twitter.com/i/web/status/1… 8 months ago

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  • Recent comments

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