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

« Older posts

  • Erik Vollebregt

  • Enter your email address to subscribe to this blog and receive notifications of new posts by email.

    Join 13,652 other subscribers

  • Subscribe via RSS

    RSS Feed RSS - Posts

    RSS Feed RSS - Comments

  • All content on this blog is subject to a Creative Commons Licence

  • Medicaldeviceslegal tweets

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

  • Most used tags on this blog

    3D printing advertising apps authorised representative Blue Guide borderline Brexit BSi business compliance CE marking Clinical evaluation Clinical investigation clinical trials COCIR commission Council Cybersecurity Dalli data protection Date of Application DIA Euromeeting e-labeling eHealth EN 14155 enforcement ENVI Eucomed Eudamed FCPA FDA GDPR GHTF guidance 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

    Kriss Anderson on The MDR proposal for extension…
    Axon Lawyers –… on The EPSCO meeting and beyond:…
    Axon Lawyers –… on IVDR amendment proposal update…

  • 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

  • Archives

Blog at WordPress.com.

medicaldeviceslegal
Blog at WordPress.com.
  • Follow Following
    • medicaldeviceslegal
      • Join 3,541 other followers
    • Already have a WordPress.com account? Log in now.
    • medicaldeviceslegal
    • Customize
    • Follow Following
    • Sign up
    • Log in
    • Report this content
    • View site in Reader
    • Manage subscriptions
    • Collapse this bar
 

Loading Comments...