medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Category: Standards

Standardisation request for MDR and IVDR refused; now what?

Team NB FAQ on EN62304 standard for software lifecycle processes

CE marking of apps: It Can Be Done and Here Is How

Regulating Medical Software and nothing new on the Recast

Standardisation, anyone?

ISO 14155:2011 is here: revised standards for medical devices clinical trials

New standard for medical technology used at home

Software design for medical devices

New EU competition rules on R&D, information exchange and standards

  • Erik Vollebregt

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  • Medicaldeviceslegal tweets

    • The #MDR proposal for extension - “Can the maker repair what he makes?” #medicaldevices #medtech #IVDR #EUMDR… twitter.com/i/web/status/1… 1 week ago
    • #MDR and #IVDR outlook for 2023 - time to restore trust in the EU medical devices regulatory system #medicaldevices… twitter.com/i/web/status/1… 4 weeks ago
    • Analysis of the #EPSCO meeting regarding #MDR extension and the #MDCG 2022-18 position paper bridging measure for t… twitter.com/i/web/status/1… 1 month ago
    • New #MDCG guidance on authorised representatives and a Dutch competent authority inspection program on authorised r… twitter.com/i/web/status/1… 2 months ago
    • The 2nd edition of The Enriched #MDR and #IVDR is available now! #EUMDR #EUIVDR #medicaldevices #IVDs… twitter.com/i/web/status/1… 3 months ago
    • New EU #productliability rules proposed - a first glance of the impact for the #medicaldevices and… twitter.com/i/web/status/1… 3 months 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… 4 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… 5 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… 5 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… 7 months ago
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  • Recent comments

    Kriss Anderson on The MDR proposal for extension…
    Axon Lawyers –… on The EPSCO meeting and beyond:…
    Axon Lawyers –… on IVDR amendment proposal update…
  • 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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