medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

Category: Vigilance

Ceci n’est pas une période de transition and first reaction to the Implant Files

Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

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

Update on Eudamed and its implications for vigilance in the EU

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

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

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

Eudamed enters into full force

  • Erik Vollebregt

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  • Medicaldeviceslegal tweets

    • #Standardisation request for #MDR and #IVDR refused - now what? #medicaldevices #medtech #eumdr #diagnostics #IVDs medicaldeviceslegal.com/2020/06/20/sta… 3 weeks ago
    • The urgency with #IVDs under the EU #IVDR #medicaldevices #medtech #dx #diagnostics #invitrodiagnostics medicaldeviceslegal.com/2020/06/08/the… 1 month ago
    • EU #MDR: where are we at Date of Entry into Force plus three years and a little bit? #medicaldevices #IVDs… twitter.com/i/web/status/1… 1 month ago
    • EU #MDR date of application move: politically a done deal now #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 2 months ago
    • New #MDCG guidance on temporary extraordinary measures related to medical device #NotifiedBody #audits during… twitter.com/i/web/status/1… 3 months ago
    • #MDR amendment proposal article 120 (3) oversight set to be fixed #medicaldevices #postponement #medtech #EUMDR… twitter.com/i/web/status/1… 3 months ago
    • The #MDR amendment proposal to move date of application by a year: more than meets the eye #medicaldevices #medtech… twitter.com/i/web/status/1… 3 months ago
    • Commission working on proposal to postpone #MDR date of application for one year #medicaldevices #medtech #eumdr medicaldeviceslegal.com/?p=6801 3 months ago
    • The #MDCG guidance on significant changes - a significant change? #medicaldevices #eumdr #medtech #MDR #IVDR… twitter.com/i/web/status/1… 3 months ago
    • The #MDR and the #Covid-19 recommendation - a possible template for fixing the MDR and #IVDR bottleneck… twitter.com/i/web/status/1… 3 months ago

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    3D printing advertising apps authorised representative Blue Guide borderline Brexit BSi business compliance CE marking Clinical evaluation Clinical investigation clinical trials COCIR Council Cybersecurity Dalli data protection Date of Application DIA Euromeeting e-labeling eHealth EN 14155 enforcement ENVI Eucomed Eudamed FCPA FDA GDPR genetic testing GHTF HCP hospitals in vitro diagnostics ivd IVDR ivds labeling Liese M&A market surveillance MDD MDR MEDDEV medicinal products mhealth mobile medical apps notified bodies notified body patents personal data PMA PMS post marketing surveillance product liability quality system Recast reprocessing revision Roth-Behrendt scrutiny Security seminar software standalone software standards subcontractors telemedicine transition plan transparency trilogue UDI Unannounced audits vigilance

  • Recent comments

    Medical Device News… on Standardisation request for MD…
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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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