medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Tag browsing: notified bodies

Batman MDR and IVDR update after the first MDCG / stakeholders meeting and an IVDR seminar

A wave of MDR and IVDR rollout coming our way

The notified body conundrum

Festive alert! Change is on its way.

In the mean time: a Staff Working Document

Surprise! Unannounced notified body audits Commission recommendation finally issued

ENVI’s 29 may debate on medical devices

Unannounced notified body visits recommendation imminent – amend your contracts and procedures now!

Fireworks! Or a disappointing dud? The 26 February ENVI workshop on the EU medical devices and IVD proposals

“U” is for unannounced audits – what’s up with those?

« Older posts
Newer posts «

  • Erik Vollebregt

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

    Join 6,930 other followers

  • 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

    • 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 week 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… 1 month ago
    • MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR #medicaldevices… twitter.com/i/web/status/1… 2 months ago
    • Happy #IVDR day! The EU IVDR is now applicable - and what does that mean? #moleculardiagnostics #medicaldevices… twitter.com/i/web/status/1… 2 months ago
    • More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking… twitter.com/i/web/status/1… 5 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… 7 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… 8 months ago
    • Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech… twitter.com/i/web/status/1… 10 months ago
    • Happy #MDR #DoA and #Swixit / no #Turkxit day! #medicaldevices #medtech #switzerland #eumdr medicaldeviceslegal.com/2021/05/26/hap… 1 year ago
    • The Enriched #MDR and #IVDR book - finally available: the first comprehensively annotated MDR and IVDR book.… twitter.com/i/web/status/1… 1 year 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 Council Cybersecurity Dalli data protection Date of Application DIA Euromeeting e-labeling eHealth EN 14155 enforcement ENVI Eucomed Eudamed FCPA FDA GDPR GHTF guidance HCP 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

    Medical Device News… on MDCG 2021-27 Q&A on import…
    Axon Lawyers –… on MDCG guidance as pseudo-legisl…
    Axon Lawyers –… on More on placing on the ma…

  • 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 6,930 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...