medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

Category: Quality system

Counting down to the MDR date of application, and the legal stuff to get right before May 2020

3D printing of custom medical devices under future EU law

New EU medical devices regulations proposals out – first impression: nothing unexpected but devil is in the details

Improving implementation: the Code for Notified Bodies

Eudamed enters into full force

M&A in the medical devices sector: full seminar

M&A seminar: EU legal & regulatory aspects

Software design for medical devices

Regulatory considerations typically overlooked in medical devices M&A transactions

  • Erik Vollebregt

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

    Join 6,378 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

    • Finally remote initial audits under the #MDR and #IVDR, or not (yet)? #medtech #diagnostics #IVDs #medicaldevices medicaldeviceslegal.com/2021/01/24/fin… 1 month ago
    • Outlook for EU #medicaldevices and #IVD regulation for 2021 - and happy new year! #medtech #eumdr #diagnostics… twitter.com/i/web/status/1… 1 month ago
    • The #Brexit ‘deal’ has finally dropped - what’s in it for the #medicaldevices industry? #MDR #IVDR #medtech #eudmr… twitter.com/i/web/status/1… 2 months ago
    • The EU Court's Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required… twitter.com/i/web/status/1… 7 months ago
    • #Standardisation request for #MDR and #IVDR refused - now what? #medicaldevices #medtech #eumdr #diagnostics #IVDs medicaldeviceslegal.com/2020/06/20/sta… 8 months ago
    • The urgency with #IVDs under the EU #IVDR #medicaldevices #medtech #dx #diagnostics #invitrodiagnostics medicaldeviceslegal.com/2020/06/08/the… 8 months 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… 8 months ago
    • EU #MDR date of application move: politically a done deal now #medicaldevices #medtech #eumdr… twitter.com/i/web/status/1… 10 months ago
    • New #MDCG guidance on temporary extraordinary measures related to medical device #NotifiedBody #audits during… twitter.com/i/web/status/1… 10 months ago
    • #MDR amendment proposal article 120 (3) oversight set to be fixed #medicaldevices #postponement #medtech #EUMDR… twitter.com/i/web/status/1… 10 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

    Uitgelicht en gespot… on Finally remote initial audits,…
    ahmednabil1956 on Finally remote initial audits,…
    Paul Kosters on Finally remote initial audits,…
  • 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.