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

    • 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 weeks 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… 1 month 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… 1 month 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… 3 months ago
    • MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR #medicaldevices… twitter.com/i/web/status/1… 3 months ago
    • Happy #IVDR day! The EU IVDR is now applicable - and what does that mean? #moleculardiagnostics #medicaldevices… twitter.com/i/web/status/1… 4 months ago
    • More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking… twitter.com/i/web/status/1… 7 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… 9 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… 10 months ago
    • Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech… twitter.com/i/web/status/1… 11 months ago

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