medicaldeviceslegal

• About Erik Vollebregt
• EU Medical Devices Links

Category: Notified Body

• 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

• Email Subscription

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

  Join 5,021 other followers

• Subscribe via RSS

   RSS - Posts

   RSS - Comments

• All content on this blog is subject to a Creative Commons Licence

  

• Medicaldeviceslegal tweets

  • #IVDR and #MDR implementation seminar on 18 May at @axonlawyers #medicaldevices #ivds medicaldeviceslegal.com/2018/04/12/ivd… https://t.co/3q4PQNRr2d 3 months ago
  • #MDR & #IVDR update after the first MDCG/stakeholders meeting and an IVD seminar at Axon Lawyers #medicaldevices… twitter.com/i/web/status/9… 3 months ago
  • An EU Court #medicaldevices #software qualification case with a twist #samd #mdr #MEDDEV medicaldeviceslegal.com/2018/01/12/an-… 6 months ago
  • Happy New Year - with the EU #MDR transition period going past halfway point #medicaldevices medicaldeviceslegal.com/2018/01/08/hap… https://t.co/PaXZpKHZza 6 months ago
  • RT @IVDAust: @MedDevLegal Australian IVD Companies may also be affected by this... 7 months ago
  • The notified body bottleneck in implementing EU #MDR and #IVDR becoming a problem for #medicaldevices manufacturers medtech.pharmaintelligence.informa.com/MT121869/Exper… 7 months ago
  • RT @mr_mag_online: Advocaten @MedDevLegal @axonlawyers @twobirdsNL @HoyngRokh blij met komst medicijnautoriteit EMA naar Amsterdam https:/… 7 months ago
  • Working on @AdvaMedUpdate workshop on implementation of the EU #MDR and #IVDR Vital for US #medicaldevices companies advamed.org/events/new-eu-… 7 months ago
  • A tsunami of EU #MDR and #IVDR implementation and guidance coming your way #medicaldevices medicaldeviceslegal.com/2017/11/25/a-w… https://t.co/1L1drMEKxT 7 months ago
  • #MDR and #IVDR workshop at @advamed on 4 Dec on gap assessment and transition… medicaldeviceslegal.com/2017/11/14/mdr… https://t.co/GQdTos0flI 8 months ago

• Most used tags on this blog

  3D printing advertising apps authorised representative borderline business compliance CE mark 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 promotion 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 and MDR implementation…
  	David Barton on IVDR and MDR implementation…
  	Erik Vollebregt on Batman MDR and IVDR update aft…

• Most used categories on this blog

  Accessories Advertising Borderline 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 Trademark law Uncategorized Vigilance

• Archives

  Archives Select Month April 2018  (1) March 2018  (1) January 2018  (2) November 2017  (3) October 2017  (1) September 2017  (3) August 2017  (1) July 2017  (1) June 2017  (1) May 2017  (2) April 2017  (2) March 2017  (1) February 2017  (2) January 2017  (1) December 2016  (3) October 2016  (1) July 2016  (1) June 2016  (4) May 2016  (3) April 2016  (1) March 2016  (1) February 2016  (1) December 2015  (1) November 2015  (3) October 2015  (1) June 2015  (5) April 2015  (2) February 2015  (1) January 2015  (3) December 2014  (1) November 2014  (3) October 2014  (3) September 2014  (3) August 2014  (1) July 2014  (2) June 2014  (1) May 2014  (1) April 2014  (4) March 2014  (4) February 2014  (1) January 2014  (5) December 2013  (3) November 2013  (3) October 2013  (5) September 2013  (5) August 2013  (4) July 2013  (4) June 2013  (3) May 2013  (4) April 2013  (8) March 2013  (5) February 2013  (4) January 2013  (1) December 2012  (2) November 2012  (2) October 2012  (2) September 2012  (4) August 2012  (1) July 2012  (1) June 2012  (2) May 2012  (1) April 2012  (3) March 2012  (4) February 2012  (3) January 2012  (3) December 2011  (2) November 2011  (1) October 2011  (5) September 2011  (3) August 2011  (2) July 2011  (3) June 2011  (4) May 2011  (4) April 2011  (6) March 2011  (5) February 2011  (4) January 2011  (6) December 2010  (7) November 2010  (9)