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

  • Erik Vollebregt

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  • Medicaldeviceslegal tweets

    • New #MDCG guidance on authorised representatives and a Dutch competent authority inspection program on authorised r… twitter.com/i/web/status/1… 3 weeks ago
    • The 2nd edition of The Enriched #MDR and #IVDR is available now! #EUMDR #EUIVDR #medicaldevices #IVDs… twitter.com/i/web/status/1… 1 month ago
    • New EU #productliability rules proposed - a first glance of the impact for the #medicaldevices and… twitter.com/i/web/status/1… 1 month ago
    • MDCG 2022-14, a new position paper by the #MDCG in an attempt to remedy the issues of #notifiedbody capacity.… twitter.com/i/web/status/1… 2 months ago
    • More on the #BlueGuide 2022: analysis of the new elements in Chapter 2 and what they mean for #medicaldevices and… twitter.com/i/web/status/1… 3 months ago
    • A first look at the new(ish) things for #medicaldevices and #IVDs in the 2022 #BlueGuide #medtech #MDR #IVDR… twitter.com/i/web/status/1… 3 months ago
    • Managing the 2024 MDR danger zone - and outlines of a potential solution in MDCG 2022-11 #medicaldevices #EUMDR… twitter.com/i/web/status/1… 5 months ago
    • MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR #medicaldevices… twitter.com/i/web/status/1… 5 months ago
    • Happy #IVDR day! The EU IVDR is now applicable - and what does that mean? #moleculardiagnostics #medicaldevices… twitter.com/i/web/status/1… 6 months ago
    • More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking… twitter.com/i/web/status/1… 9 months ago

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