medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
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Tag browsing: Dalli

MedTech Forum 2012: “S is for scrutiny, which we’re not sure about”

What to expect in the new EU in vitro diagnostics regulation?

Update on Commission reaction to ENVI resolution – no PMA proposal on the table

It’s official: the ENVI resolution is out in final version – EU Commission changes tack to propose PMA for devices

EU ENVI Parliamentary Committee resolution re Review : “learn the lessons of this fraud” and an FDA internal report

Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

The latest on the Recast, Review, Revision of EU medical devices framework

  • Erik Vollebregt

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  • Medicaldeviceslegal tweets

    • The EU Court's Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required… twitter.com/i/web/status/1… 2 months ago
    • #Standardisation request for #MDR and #IVDR refused - now what? #medicaldevices #medtech #eumdr #diagnostics #IVDs medicaldeviceslegal.com/2020/06/20/sta… 3 months ago
    • The urgency with #IVDs under the EU #IVDR #medicaldevices #medtech #dx #diagnostics #invitrodiagnostics medicaldeviceslegal.com/2020/06/08/the… 3 months ago
    • EU #MDR: where are we at Date of Entry into Force plus three years and a little bit? #medicaldevices #IVDs… twitter.com/i/web/status/1… 3 months ago
    • EU #MDR date of application move: politically a done deal now #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 5 months ago
    • New #MDCG guidance on temporary extraordinary measures related to medical device #NotifiedBody #audits during… twitter.com/i/web/status/1… 5 months ago
    • #MDR amendment proposal article 120 (3) oversight set to be fixed #medicaldevices #postponement #medtech #EUMDR… twitter.com/i/web/status/1… 5 months ago
    • The #MDR amendment proposal to move date of application by a year: more than meets the eye #medicaldevices #medtech… twitter.com/i/web/status/1… 5 months ago
    • Commission working on proposal to postpone #MDR date of application for one year #medicaldevices #medtech #eumdr medicaldeviceslegal.com/?p=6801 6 months ago
    • The #MDCG guidance on significant changes - a significant change? #medicaldevices #eumdr #medtech #MDR #IVDR… twitter.com/i/web/status/1… 6 months ago

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  • Recent comments

    Axon Lawyers –… on The MDCG cybersecurity guidanc…
    Auswirkungen der MDR… on IVDR, in-house developed tests…
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