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

    • Managing the 2024 MDR danger zone - and outlines of a potential solution in MDCG 2022-11 #medicaldevices #EUMDR… twitter.com/i/web/status/1… 2 weeks ago
    • MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR #medicaldevices… twitter.com/i/web/status/1… 1 month ago
    • Happy #IVDR day! The EU IVDR is now applicable - and what does that mean? #moleculardiagnostics #medicaldevices… twitter.com/i/web/status/1… 1 month ago
    • More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking… twitter.com/i/web/status/1… 4 months ago
    • 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… 6 months ago
    • #IVDR amendment proposal moving on up to adoption with Council not touching the Commission's proposed text… twitter.com/i/web/status/1… 7 months ago
    • Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech… twitter.com/i/web/status/1… 8 months ago
    • Happy #MDR #DoA and #Swixit / no #Turkxit day! #medicaldevices #medtech #switzerland #eumdr medicaldeviceslegal.com/2021/05/26/hap… 1 year ago
    • The Enriched #MDR and #IVDR book - finally available: the first comprehensively annotated MDR and IVDR book.… twitter.com/i/web/status/1… 1 year 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… 1 year ago

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