| When the European Commission published its public consultation document
concerning the recast of the current EU provisions governing medical devices
on 7th May 2008, this did not come as a great surprise to the informed public.
In its ‘Communication to the European Parliament and the Council’ in 2005 on
Implementing the Community Lisbon programme the Commission had already
indicated its intention to recast two of the three basic EU Directives governing
medical devices into a simplified regulation.
While the subsequent proposal
may have been “much awaited” (as the Commission’s own press release claimed)
it was not in the form of a regulation. Moreover, there was a certain level
of disappointment that the proposal, as finally submitted, did not constitute the
overhaul of the existing medical device legislation that was hoped for in at least
some corners.
No explanation as to the change of legislative approach
was provided in either the impact assessment report for the
Commission’s proposal or in the explanatory memorandum that
accompanied the proposal. Moreover, even before the resultant
modifications to Directive 90/385/EEC (1) and Directive
93/42/EEC (2) had been adopted, there were already rumblings
that it was time for a complete revision of EU medical device
law. While the EU member states are still implementing the
last set of amendments to the medical devices directives, and
manufacturers continue to determine the likely impact of these
for their products, the Commission is proposing a revision of
this existing framework in order “to improve and strengthen
the legal framework for the regulation of medical devices
in Europe”. |
