Intended for healthcare professionals


Europe is updating rules on medical devices after implant fiasco

BMJ 2012; 344 doi: (Published 30 January 2012) Cite this as: BMJ 2012;344:e766
  1. Rory Watson
  1. 1Brussels

Pressure is growing for stricter European controls on medical devices and better traceability after the discovery of defective silicone gel breast implants manufactured by the French company Poly Implants Prosthèses (PIP).

The European Commission, after being questioned by a British Labour member of the European parliament, Linda McAvan, confirmed last week that it is working on updating existing medical devices legislation that came into force in March 2010.

While welcoming the move, Mrs McAvan suggested that because many women are unsure whether their breast implants are defective, unique identification of products could ensure effective tracking in future. With up to 500 000 women (mostly outside the European Union) affected, the Labour MEP also emphasised the need for better international cooperation.

The Belgian Liberal MEP Fréderique Ries also called on the commission to request a study into the possible health risks of silicone implants in general.

The commission had already begun assessing how to update the existing medical devices legislation two years before the French authorities became aware of the defective implants in early 2010 and is expected to present proposals before the end of June.

Among the options being considered are strengthening the designation and monitoring by national authorities of the notified bodies that verify the standards of medical devices and closer coordination among national administrations on vigilance and market surveillance. This could include central reporting of incidents and trend analyses. Thought is also being given to the introduction of traceability requirements by using a unique device identification for certain products.

Although the commission has indicated that it does not intend to propose premarket authorisation for medical devices, the idea has support in the European parliament, and the German Socialist MEP Dagmar Roth-Behrendt has said that it might be appropriate for certain products.

EU officials suggest that there is unlikely to be a Europe-wide register of people who have had a medical device fitted but indicate that nothing would prevent individual countries from establishing one.

The commission has also launched an inquiry into the scale of the problem of defective implants in Europe and the action taken in different countries. The findings are expected within days.

Under existing European legislation, in force since March 2010, manufacturers of implantable medical devices and those considered to be the highest risk must perform a clinical investigation, unless existing clinical data are considered sufficient. In December 2010 the commission set out guidelines explaining how the investigations should be conducted.

In addition, manufacturers must conduct post-market clinical follow-up as part of their post-market surveillance plan. The commission is currently preparing guidance on how to meet this requirement.


Cite this as: BMJ 2012;344:e766

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