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Eucomed backs EC plans to strengthen medical devices measures

Implant registers, support for adverse event reporting and increased spot checks by Member States encouraged after PIP controversy

The European Commission's (EC) plans to strengthen its existing medical devices legislation in the wake of the PIP breast implants controversy have been backed by industry body Eucomed.

The proposed measures aim to make EC Member States tighten controls, improve the safety guarantee for medical devices and restore patient confidence in devices legislation.

PIP implants, which were withdrawn in the EU in 2010, were found to be made with low-grade silicone with an increased risk of rupturing, with weak European legislation taking some of the blame for allowing the implants to reach the market.

European Health and Consumer Policy Commissioner John Dalli has written to Member States proposing several actions including reinforcing market surveillance by increasing 'spot checks' of manufacturing facilities.

Other actions included improving the vigilance system for medical devices by encouraging healthcare professionals and patients to report adverse events as well as developing the co-ordination of analysing reported incidents.

Giving systematic access for notified bodies to reports of adverse events was also suggested, as well as supporting the development of tools - like Unique Device Identification systems and implant registers - to trace medical devices and monitor their long-term safety and performance.

These plans were announced ahead of the EC's planned revision of the medical devices legislation, scheduled for adoption in the spring, and have support from Eucomed, the European body for medical devices.

In a statement, the organisation said the EC's measures were "balanced and appropriate and will have a positive effect on patient safety".

Device legislation is still under review, however, and Eucomed offered six improvements to create what it describes as a "smarter legal framework for medical devices".

These are:

• Only the best Notified Bodies

• One approach to vigilance and market surveillance

• Strengthened harmonised standards

• Consistent implementation of guidelines

• Increased transparency

• An integrated approach: better coordination and management.

Eucomed has released a position paper, entitled 'A new EU regulatory framework for medical devices', with further information on the changes it would like to see to European legislation.

Earlier this week, former Eucomed CEO John Wilkinson joined the Medicines and Healthcare products Regulatory Agency (MHRA) as its director of medical devices in the UK, where 40,000 women are thought to have received PIP implants.

10th February 2012


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