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MEPs to vote on tougher rules on breast implants

Committee vote delayed because of amendments Extent of EU powers disputed

A proposal to increase regulatory scrutiny of medical devices will be put to the vote in the European Parliament’s environment and health committee next week (25 September).

The legislation, which is in part a response to last year’s scandal over leaking breast implants, has provoked much controversy and hundreds of amendments in the Parliament.

The committee had scheduled the proposal for voting yesterday (18 September), but the votes have been delayed while MEPs and officials attempt to reduce the number of amendments.

The main political groups have, however, reached a compromise on the most contentious issue: whether central EU authorisation should be required for high-risk devices such as implants and joint replacements.

It was a year ago that the European Commission proposed increased controls over authorising bodies. A scheduled review of existing legislation was given extra urgency by a health scare over breast implants. The company PIP is alleged to have used an industrial-grade silicone instead of medical silicone in the implants, making them prone to rupture. The implants were approved by a private German assessment body.

Under current rules, dating from 1990, medical devices such as implants and pacemakers are given pre-market authorisation by accredited independent assessment bodies – known as ‘notified bodies’. There are roughly 80 of these bodies in the EU, some public and some private.

The Commission wants closer supervision of the process, including powers for national authorities to conduct unannounced factory inspections and sample testing. Its proposal would also introduce an EU-level supervisory co-ordination group and create an extended EU-wide database on medical devices to share information across member states.

EU authorisation

German centre-left MEP Dagmar Roth Behrendt wanted the EU law to go further. She proposed that the 30 or so specialised notified bodies that assess the more complex medical devices should be subject to centralised EU authorisation. But centre-right German MEP Peter Liese opposed this, saying that this would be impractical, with so many new medical devices coming onto the market each year, and bureaucracy would delay approval of much-needed new devices.

The two political groups have reached a compromise whereby the specialised notified bodies would not need central authorisation but would be subject to scrutiny by the EU.

The EU could overrule approval for a product in extraordinary cases. It could also introduce unannounced inspections at companies making medical devices.

European doctors have urged not only a harmonisation of legislative standards, but also more detailed guidelines. But the devices industry is warning that what it terms excessive controls will damage innovation and delay products being made available to patients.

The Council of Ministers has yet to decide its position on the proposal, and MEPs are worried that the legislation will not be passed before the elections to the European Parliament next May.

“The text has been on the table for a year and the Council hasn’t agreed on anything yet,” Liese said. “The Lithuanian presidency needs to speed it up. I cannot go to elections in May and say, yes we have understood that there are big problems [after the PIP breast implant scare], but all we’ve done is a first reading, after one year.”