Article

New EU guidance on medical devices vigilance reporting – more than meets the eye

19 Mar 2012, Erik Vollebregt The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7….

Article

Update on Eudamed and its implications for vigilance in the EU

21 Feb 2012, Erik Vollebregt This will be a very short post, because everything I could write down on the subject is in the interview I had with Ashley Yeo of Scrip Regulatory Affairs, that kindly consented…

Article

Outlines of the medical devices Recast become more fixed with Council conclusions

08 Jun 2011, Erik Vollebregt Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the…

Article

Critical analysis of the European Society of Cardiologists' report on medical devices problems, and its proposals for reform

23 May 2011, Erik Vollebregt Reader warning: this will be a longer-than-usual post, because I did not have time to write a short one (to cite the many philosophers and writers credited for this quote). The European…

Article

Usability engineering – how to involve users?

05 Jan 2011, Erik Vollebregt With the revision of the EU medical devices directive that entered into force last year stricter requirements on usability engineering have entered into force. The very first essential requirement under that directive…