Notified Bodies for the Certification of Medical Devices Sign Code of Conduct

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 ...

EU Member States Stress Importance of Medtech Innovation for Maintaining Sustainable Healthcare Systems

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 ...

And Now for Something Completely Different: Why Europe’s Regulatory System for Medical Devices Works

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 ...