medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

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

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  • Medicaldeviceslegal tweets

    • Some critical remarks on inconsistencies and new requirements in MDCG 2021-27 guidance Q&A on importers and distrib… twitter.com/i/web/status/1… 1 month ago
    • #IVDR amendment proposal moving on up to adoption with Council not touching the Commission's proposed text… twitter.com/i/web/status/1… 1 month ago
    • Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech… twitter.com/i/web/status/1… 3 months ago
    • Happy #MDR #DoA and #Swixit / no #Turkxit day! #medicaldevices #medtech #switzerland #eumdr medicaldeviceslegal.com/2021/05/26/hap… 8 months ago
    • The Enriched #MDR and #IVDR book - finally available: the first comprehensively annotated MDR and IVDR book.… twitter.com/i/web/status/1… 8 months ago
    • The new EU AI regulation proposal and its impact for EU medical devices and IVDs regulation #MDR #IVDR… twitter.com/i/web/status/1… 8 months ago
    • #MDR date of application next month - and the Enriched MDR and IVDR book #IVDR #economicoperators #swixit #turkxit… twitter.com/i/web/status/1… 9 months ago
    • Finally remote initial audits under the #MDR and #IVDR, or not (yet)? #medtech #diagnostics #IVDs #medicaldevices medicaldeviceslegal.com/2021/01/24/fin… 1 year ago
    • Outlook for EU #medicaldevices and #IVD regulation for 2021 - and happy new year! #medtech #eumdr #diagnostics… twitter.com/i/web/status/1… 1 year 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… 1 year ago

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