medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Category: Telemedicine

The MDCG cybersecurity guidance – a helpful rush job

Team NB FAQ on EN62304 standard for software lifecycle processes

EU Data protection developments: privacy by design – literally, may impact your design

Happy New Year – with all those developments

The new Commission eHealth Action Plan, and some thoughts on what it will mean for devices

  • Erik Vollebregt

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  • Medicaldeviceslegal tweets

    • 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… 6 days 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… 1 month ago
    • MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR #medicaldevices… twitter.com/i/web/status/1… 2 months ago
    • Happy #IVDR day! The EU IVDR is now applicable - and what does that mean? #moleculardiagnostics #medicaldevices… twitter.com/i/web/status/1… 2 months ago
    • More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking… twitter.com/i/web/status/1… 5 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… 7 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… 8 months ago
    • Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech… twitter.com/i/web/status/1… 10 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
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    Accessories Advertising Borderline Brexit Business compliance CE marking Clinical evaluation Clinical investigation Data Protection e-commerce eHealth Eudamed FCPA In Vitro Diagnostics IVDR Labeling M&A MDR mHealth Notified Body Personal data Placing on the market PMS Product liability Quality system Recast Software Standards Uncategorized Vigilance
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