medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
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Tag browsing: notified bodies

The notified body conundrum

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?

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

Critical analysis of the European Society of Cardiologists’ report on medical devices problems, and its proposals for reform

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  • Medicaldeviceslegal tweets

    • Outlook for EU #medicaldevices and #IVD regulation for 2021 - and happy new year! #medtech #eumdr #diagnostics… twitter.com/i/web/status/1… 3 weeks ago
    • The #Brexit ‘deal’ has finally dropped - what’s in it for the #medicaldevices industry? #MDR #IVDR #medtech #eudmr… twitter.com/i/web/status/1… 3 weeks ago
    • The EU Court's Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required… twitter.com/i/web/status/1… 6 months ago
    • #Standardisation request for #MDR and #IVDR refused - now what? #medicaldevices #medtech #eumdr #diagnostics #IVDs medicaldeviceslegal.com/2020/06/20/sta… 7 months ago
    • The urgency with #IVDs under the EU #IVDR #medicaldevices #medtech #dx #diagnostics #invitrodiagnostics medicaldeviceslegal.com/2020/06/08/the… 7 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… 7 months ago
    • EU #MDR date of application move: politically a done deal now #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 9 months ago
    • New #MDCG guidance on temporary extraordinary measures related to medical device #NotifiedBody #audits during… twitter.com/i/web/status/1… 9 months ago
    • #MDR amendment proposal article 120 (3) oversight set to be fixed #medicaldevices #postponement #medtech #EUMDR… twitter.com/i/web/status/1… 9 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… 9 months ago

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