medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

Category: Audits

Surprise! Unannounced notified body audits Commission recommendation finally issued

In the mean time… joint immediate action plan, unannounced audits and other things over the summer

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

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

  • Erik Vollebregt

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

    Join 6,219 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

    • #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

  • 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 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…
    Warren Craycroft on Standardisation request for MD…
    Erik Vollebregt on Standardisation request for MD…

  • 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.