medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Tag browsing: Clinical investigation

Compromise texts for EU Council EPSCO meeting public

Axon Seminar Clinical Trials with Medicinal Products and Medical Devices on 9 April in Amsterdam

Netherlands medical devices compliance update

The moment is NOW! And medicinal product trials requirements feedback in medical devices clinical requirements

Guest blog: no enhanced patient safety resulting from rapporteur Roth-Behrendt’s proposal

Hold on to your seat: ENVI’s Dagmar Roth-Behrendt report is here

Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 2

Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 1

Outlines of the medical devices Recast become more fixed with Council conclusions

Critical analysis of the European Society of Cardiologists’ report on medical devices problems, and its proposals for reform

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  • Medicaldeviceslegal tweets

    • More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking… twitter.com/i/web/status/1… 3 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… 4 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… 5 months ago
    • Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech… twitter.com/i/web/status/1… 7 months ago
    • Happy #MDR #DoA and #Swixit / no #Turkxit day! #medicaldevices #medtech #switzerland #eumdr medicaldeviceslegal.com/2021/05/26/hap… 12 months ago
    • The Enriched #MDR and #IVDR book - finally available: the first comprehensively annotated MDR and IVDR book.… twitter.com/i/web/status/1… 12 months 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
    • #MDR date of application next month - and the Enriched MDR and IVDR book #IVDR #economicoperators #swixit #turkxit… twitter.com/i/web/status/1… 1 year ago
    • Finally remote initial audits under the #MDR and #IVDR, or not (yet)? #medtech #diagnostics #IVDs #medicaldevices medicaldeviceslegal.com/2021/01/24/fin… 1 year ago
    • Outlook for EU #medicaldevices and #IVD regulation for 2021 - and happy new year! #medtech #eumdr #diagnostics… twitter.com/i/web/status/1… 1 year ago

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