medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

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

    • Commission working on proposal to postpone #MDR date of application for one year #medicaldevices #medtech #eumdr medicaldeviceslegal.com/?p=6801 1 week ago
    • The #MDCG guidance on significant changes - a significant change? #medicaldevices #eumdr #medtech #MDR #IVDR… twitter.com/i/web/status/1… 1 week ago
    • The #MDR and the #Covid-19 recommendation - a possible template for fixing the MDR and #IVDR bottleneck… twitter.com/i/web/status/1… 2 weeks ago
    • New #MDCG Class I Article 120 (3) and (4) #MDR guidance - nothing new but nice summary of requirements… twitter.com/i/web/status/1… 2 weeks ago
    • The #MDCG #cybersecurity guidance - a helpful rush job #medicaldevices #ehealth #mhealth #medtech #euMDR #MDR #IVDR… twitter.com/i/web/status/1… 2 weeks ago
    • The #MDCG MDR joint implementation plan for the #MDR (not the #IVDR) #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 3 weeks ago
    • #Brexit is a fact - now deal with it And what does that mean for #medicaldevices for the coming years?… twitter.com/i/web/status/1… 2 months ago
    • Welcome to 2020 - year of the proof of the MDR pudding #medicaldevices #MDR #medtech medicaldeviceslegal.com/2020/01/13/wel… https://t.co/lLMM4h8CMt 2 months ago
    • A not so happy #MDR and #IVDR Christmas Carol #medtech #eumdr #medicaldevices medicaldeviceslegal.com/2019/12/25/a-n… https://t.co/GNyRDJ5TcF 3 months ago
    • More on the #PRRC under new EU #medicaldevices regulations #MDR #IVDR medicaldeviceslegal.com/2019/12/12/mor… 3 months ago

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