Wednesday, September 28th, 2011
The work of Notified Bodies (“NBs”) in the conformity assessment and certification of medical devices is a key cornerstone of the EU legislative system to safeguard public health. Established in the early 1990s to replace the nationally existing systems in the European member states, the legal framework follows the principles ...
Posted in Regulation | Add Comment »
Monday, June 6th, 2011
The Council of the European Union has emphasised the importance of medtech innovation in improving health outcomes and the sustainability of European healthcare systems, writes Eucomed in a press release issued today. European Member States also reaffirmed their support of the current legal framework, recommending focused attention to essential amendments ...
Posted in medtechinsider, Regulation | Add Comment »
Wednesday, May 18th, 2011
As noted in the Daily Buzz yesterday on emdt.co.uk, there has been something of a feeding frenzy among the media questioning the efficacy and safety of Europe's regulatory system for medical devices. One of the more colourful comments is attributed to Nick Freemantle, Professor of clinical epidemiology and biostatistics, writing ...
Posted in Opinion, Regulation | Add Comment »
