medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

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

    • 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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    3D printing advertising apps authorised representative 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 importer in vitro diagnostics ivd IVDR ivds labeling Liese M&A market surveillance MDCG MDD MDR MEDDEV medicinal products mhealth mobile medical apps notified bodies notified body patents personal data placing on the market PMA PMS post marketing surveillance product liability quality system Recast reprocessing revision Roth-Behrendt scrutiny seminar software standards subcontractors Swixit telemedicine transition plan transparency Turkxit UDI Unannounced audits vigilance

  • Recent comments

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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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