medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Tag browsing: MEDDEV

An unsurprising case of software qualification

Software MEDDEV ‘updated’

EU court decides another borderline case regarding “pharmacological effect”

Everything you always wanted to know about stand alone software, but were afraid to ask

New EU guidance on medical devices vigilance reporting – more than meets the eye

New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

Standalone software regulated as medical device: a look under the hood of the draft MEDDEV

EU court to clarify medical device / drug borderline and the status of MEDDEV documents

New European Commission guidelines for clinical investigations

  • Erik Vollebregt

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  • Medicaldeviceslegal tweets

    • EU #MDR extension amendment and #IVDR / # MDR sell-off period removal amendment entered into force now… twitter.com/i/web/status/1… 1 week ago
    • Almost there for the EU #MDR extension and #IVDR removal of sell-off period proposal - accelerated procedure starte… twitter.com/i/web/status/1… 1 month ago
    • The #MDR proposal for extension - “Can the maker repair what he makes?” #medicaldevices #medtech #IVDR #EUMDR… twitter.com/i/web/status/1… 2 months 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… 2 months 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… 3 months ago
    • New #MDCG guidance on authorised representatives and a Dutch competent authority inspection program on authorised r… twitter.com/i/web/status/1… 4 months ago
    • The 2nd edition of The Enriched #MDR and #IVDR is available now! #EUMDR #EUIVDR #medicaldevices #IVDs… twitter.com/i/web/status/1… 5 months ago
    • New EU #productliability rules proposed - a first glance of the impact for the #medicaldevices and… twitter.com/i/web/status/1… 5 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… 6 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… 7 months ago
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