medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt
  • EU Medical Devices Links

Category: Quality system

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

« Older posts

  • Erik Vollebregt

    Erik is a founding partner of the boutique life sciences law firm Axon Lawyers and specialised in EU legal and regulatory issues relating to medical technology

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

    Join 5,542 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

    • National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 1 week ago
    • IVDR, in-house developed tests and the state of MDR/IVDR implementation medicaldeviceslegal.com/2019/05/12/ivd… https://t.co/E4x5ZJGzYf 1 week ago
    • This was not the Corrigendum you were looking for, more #MDCG guidance on #scrutiny and national #Brexit exemption… twitter.com/i/web/status/1… 1 month ago
    • What to expect for 2019 with EU #MDR and #IVDR implementation? #medicaldevices #ivds #medtech #invitrodiagnostics… twitter.com/i/web/status/1… 2 months ago
    • Don't give me #Brexit problems, give me Brexit scenarios #medicaldevices #IVDs #medtech #CEcertificates #CEmarking… twitter.com/i/web/status/1… 3 months ago
    • First notified body for EU MDR designated! #MDR #IVDR #medtech #medicaldevices medicaldeviceslegal.com/2019/01/21/fir… https://t.co/X46AeuHftM 4 months ago
    • The implementation of the new EU #MDR and # IVDR in 2019: up or out, sink or swim #medicaldevices #ivds #medtech… twitter.com/i/web/status/1… 4 months ago
    • Ceci n'est pas une période de transition and first reaction to the #ImplantFiles - #mdr #ivdr #medicaldevices… twitter.com/i/web/status/1… 5 months ago
    • #MDR / #IVDR Implementation: the transition period for the EU medical devices regulations at the halfway point semi… twitter.com/i/web/status/1… 7 months ago
    • Bottlenecks, #Brexit and stalling CAMD roll-out - a new post on #MDR and #IVDR implementation #medicaldevices… twitter.com/i/web/status/1… 9 months ago

  • Most used tags on this blog

    3D printing advertising apps authorised representative borderline Brexit BSi business compliance CE marking Clinical evaluation Clinical investigation clinical trials COCIR competition law conferences Council Cybersecurity Dalli data protection 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

    Erik Vollebregt on IVDR, in-house developed tests…
    David G on IVDR, in-house developed tests…
    Michael Maier on This was not the Corrigendum y…

  • Most used categories on this blog

    Accessories Advertising Borderline Brexit Business compliance CE marking Clinical evaluation Clinical investigation Data Protection e-commerce eHealth FCPA Intellectual property In Vitro Diagnostics Labeling M&A mHealth Notified Body Patents Personal data Placing on the market PMS Product liability Quality system Recast Scrutiny Software Standards Uncategorized Vigilance

  • Archives

Blog at WordPress.com.

medicaldeviceslegal
Blog at WordPress.com.
Cancel