medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Category: Product liability

The New Product Liability Directive(s) proposals and medical devices / IVDs

Counting down to the MDR date of application, and the legal stuff to get right before May 2020

EU Court decides TÜV Rheinland / PIP breast implants case

Product liability for devices under MDR and IVDR

European Court of Justice introduces ‘product batch’ liability

ENVI’s amendments

EU court rules on no-fault liability for medical services with medical devices

Developments in EU product liability for medical devices – or not

Software as medical device – regulatory requirements, product liability

  • 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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  • Recent comments

    Axon Lawyers –… on The New Product Liability Dire…
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  • Most used categories on this blog

    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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