medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

Category: Quality system

3D printing of custom medical devices under future EU law

New EU medical devices regulations proposals out – first impression: nothing unexpected but devil is in the details

Improving implementation: the Code for Notified Bodies

Eudamed enters into full force

M&A in the medical devices sector: full seminar

M&A seminar: EU legal & regulatory aspects

Software design for medical devices

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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

    • New sort of applicable economic operators regulation for medical devices in the EU: the Market Surveillance Regulat… twitter.com/i/web/status/1… 4 weeks ago
    • € 500 per data subject in immaterial damages - a quantification of why #GDPR matters #dataprotection #cybersecurity… twitter.com/i/web/status/1… 1 month 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… 2 months ago
    • 'Person responsible for regulatory compliance" #PRRC guidance under EU #MDR and #IVDR published #medicaldevices… twitter.com/i/web/status/1… 2 months ago
    • Bottleneck of bottlenecks for #notifiedbody capacity under EU #medicaldevices law #mdr #ivdr medicaldeviceslegal.com/2019/06/13/bot… https://t.co/McscK8wqPU 3 months ago
    • National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 4 months ago
    • IVDR, in-house developed tests and the state of MDR/IVDR implementation medicaldeviceslegal.com/2019/05/12/ivd… https://t.co/E4x5ZJGzYf 4 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… 5 months ago
    • What to expect for 2019 with EU #MDR and #IVDR implementation? #medicaldevices #ivds #medtech #invitrodiagnostics… twitter.com/i/web/status/1… 6 months ago
    • Don't give me #Brexit problems, give me Brexit scenarios #medicaldevices #IVDs #medtech #CEcertificates #CEmarking… twitter.com/i/web/status/1… 6 months ago

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  • Recent comments

    Axon Lawyers –… on REACH is upon us
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    Uitgelicht en gespot… on € 500 per data subject –…

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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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