medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Tag browsing: MDR

Focus on the authorised representative

The 2nd edition of The Enriched MDR and IVDR is available now

Verelendung is a process, people!

The new Blue Guide 2022 – not much new for devices and IVDs, but certainly more confusion

Managing the 2024 MDR danger zone – and outlines of a potential solution in MDCG 2022-11

MDCG 2021-27 Q&A on importers and distributors – sort of box of chocolates

The Enriched MDR and IVDR – finally available

The new EU AI regulation proposal, medical devices and IVDs

MDR date of application next month – and the book

Finally remote initial audits, or not (yet)?

« Older posts
Newer posts «
  • Erik Vollebregt

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

    Join 11.9K 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

    Tweets by MedDevLegal
  • 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

    Donald Alexander's avatarDonald Alexander on Happy 2025 – more churn…
    neilra's avatarneilra on The German angle
    Michael Wienholt's avatarMichael Wienholt on The German angle
  • 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.
  • Subscribe Subscribed
    • medicaldeviceslegal
    • Join 3,863 other subscribers
    • Already have a WordPress.com account? Log in now.
    • medicaldeviceslegal
    • Subscribe Subscribed
    • Sign up
    • Log in
    • Report this content
    • View site in Reader
    • Manage subscriptions
    • Collapse this bar
 

Loading Comments...