* Lawmakers reject U.S.-style pre-marketing product approval
* Rules must now be finalised in talks with EU governments
STRASBOURG Oct 22 The European Parliament
backed plans on Tuesday to tighten EU rules on medical devices
that stopped short of a U.S.-style pre-marketing approval system
that industry had warned would delay the introduction of new
Proposals to toughen up European Union legislation on
medical devices followed a 2011 scandal involving France's now
defunct Poly Implant Prothese (PIP), which for up to a decade
made substandard breast implants that were used by hundreds of
thousands of women worldwide.
Some blamed the scandal on Europe's current authorisation
system, which is less strict than in the United States where
extensive testing is required before new products are approved.
Under the U.S. system new products have to prove their efficacy
in a similar way to medicines.
The parliament, voting in Strasbourg on Tuesday, backed
plans for tighter monitoring of device manufacturers - including
unannounced inspections - designed to prevent another PIP
The plans cover a whole range of medical devices such as hip
replacements, heart valves and pacemakers. Major manufacturers
of medical devices include Johnson & Johnson, Medtronic
, Boston Scientific, Abbott, Allergan
and Smith & Nephew.
The 80 or so mostly private "notified bodies" that decide on
product safety will face tougher certification standards. These
bodies are often private companies to which national authorities
outsource medical device inspections.
The aim is now to tighten up the process to make sure only a
limited number of these companies with appropriate specialist
knowledge can assess high-risk devices - basically any device
implanted in the body. Such devices may then be subjected to
tougher assessment procedures.
But the parliament ignored calls from some members to
establish a centralised EU pre-marketing approval process along
the lines of the U.S. system, which would have given the
European Commission the final say over approvals, a development
welcomed by the industry.
"All in all, there have been positive developments in
parliament between the committee phase and the plenary vote,"
Serge Bernasconi, head of industry body Eucomed, said in a
The parliament agreed to open negotiations with EU
governments to try to finalise the legislation.
But member states are not expected to finalise their common
position before the end of this year. That means a final
agreement may not be possible before 2015 because of
parliamentary elections and a change-over of Commissioners in