European Parliament Calls for Premarket Authorization System in Wake of PIP

As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry.

In a unanimous resolution April 25, the Committee on Environment, Public Health and Food Safety also urges strengthened postmarket surveillance and safety controls, better coordination of adverse event reports and systematic access for notified bodies to such reports. Frequent, unannounced inspections of device plants by local authorities, enhanced controls of notified bodies and more sample testing of products already on the market are also needed to ensure the safety of devices in the EU, the resolution states.

In addition, the committee recommends creating a European database of device information, facility registration, vigilance and market surveillance, clinical investigations, notified bodies and EC certificates.

Breast implant registers should be mandated in each member state and the database connected to a medical device implant recipient’s passport, the committee said. The passports would provide specific characteristics of the implant and potential adverse side effects.

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