Euro-MP welcomes safer breast implants

MEPs this week agreed to new rules for the safety and performance of medical devices and diagnostic devices.

Rochdale Liberal Democrat MEP Chris Davies had called for improvements to safety laws following the PIP breast implant scandal where EU authorities seemed powerless to inspect factory facilities.

Mr Davies said, “The EU was responsible for certifying the safety of these devices but there were few safeguards in place to check manufacturers were playing by the rules.”

MEPs endorsed plans for stricter market surveillance including unannounced inspections of manufacturers and better traceability rules.

Mr Davies supported the measures as an example of where the EU had a bigger role to play in ensuring patient safety.

He said, “Women who have implants for any reason should not have to worry about whether what they are putting in their body is safe. They have every right to expect that if a product is certified it has passed safety tests.

“There is a Europe-wide market in medical devices and an implant manufactured in France should be as safe as one made in the UK. Today’s vote is one step closer to safer medicine across the continent.”

In the same set of regulations, Lib Dem MEPs objected to proposals to make some in-vitro diagnostic medical devices such as making HIV tests subject to medical prescription.

Mr Davies added, “It is not in the interests of public health to restrict access to some high risk tests, such as HIV tests. It is right that in the UK HIV tests are easily available in order to reach certain high risk groups "

The text adopted by the Parliament will now be negotiated with national governments in the coming months.