* Lawmakers reject U.S.-style pre-marketing product approval
* Rules must now be finalised in talks with EU governments
STRASBOURG, Oct 22 (Reuters) - The European Parliamentbacked plans on Tuesday to tighten EU rules on medical devicesthat stopped short of a U.S.-style pre-marketing approval systemthat industry had warned would delay the introduction of newtreatments.
Proposals to toughen up European Union legislation onmedical devices followed a 2011 scandal involving France's nowdefunct Poly Implant Prothese (PIP), which for up to a decademade substandard breast implants that were used by hundreds ofthousands of women worldwide.
Some blamed the scandal on Europe's current authorisationsystem, which is less strict than in the United States whereextensive testing is required before new products are approved.Under the U.S. system new products have to prove their efficacyin a similar way to medicines.
The parliament, voting in Strasbourg on Tuesday, backedplans for tighter monitoring of device manufacturers - includingunannounced inspections - designed to prevent another PIPscandal.
The plans cover a whole range of medical devices such as hipreplacements, heart valves and pacemakers. Major manufacturersof medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott, Allergan and Smith & Nephew.
The 80 or so mostly private "notified bodies" that decide onproduct safety will face tougher certification standards. Thesebodies are often private companies to which national authoritiesoutsource medical device inspections.
The aim is now to tighten up the process to make sure only alimited number of these companies with appropriate specialistknowledge can assess high-risk devices - basically any deviceimplanted in the body. Such devices may then be subjected totougher assessment procedures.
But the parliament ignored calls from some members toestablish a centralised EU pre-marketing approval process alongthe lines of the U.S. system, which would have given theEuropean Commission the final say over approvals, a developmentwelcomed by the industry.
"All in all, there have been positive developments inparliament between the committee phase and the plenary vote,"Serge Bernasconi, head of industry body Eucomed, said in astatement.
The parliament agreed to open negotiations with EUgovernments to try to finalise the legislation.
But member states are not expected to finalise their commonposition before the end of this year. That means a finalagreement may not be possible before 2015 because ofparliamentary elections and a change-over of Commissioners in2014.
Smith & Nephew (SN.)
