medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Category: Uncategorized

Proposal to manage IVDR

A not so happy MDR and IVDR Christmas Carol

More on the PRRC

The Commission and the Council on the MDR state of affairs

Corrigendum 2 and the (potential) consequences for class I devices

€ 500 per data subject – a quantification of why GDPR matters

National MDR and IVDR implementation news – Netherlands implementation decree consultation

IVDR, in-house developed tests and the state of MDR/IVDR implementation

This was not the Corrigendum you were looking for

Don’t give me Brexit problems, give me Brexit scenarios

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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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