EU Parliament stops short of US-style approvals for medical devices

Tue Oct 22, 2013 4:07pm BST

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* 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 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 treatments.

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 scandal.

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 statement.

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 2014.

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