Tuesday 20 February 2018

EU Looks to Tighten Medical Device Safety With Implant Registry

In the wake of high-level scandals in the EU, including the Poly Implant Prothese (PIP) breast implant snafu and the metal-on-metal hip implants manufactured Johnson & Johnson and others, the European Parliament has made several proposals to increase device safety. These proposals include the creation of breast implant registers, product traceability and a pre-market authorization system, among other proposals, to prevent similar incidents involving implantable devices from occurring in the future.

The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, according to reports from Fierce Medical Devices.

A Committee within the European Parliament unanimously passed a resolution on April 25th advancing the above proposals, saying “it is essential to […] strengthen surveillance and safety controls and placing on the market requirements.”

The members emphasize the registers should be interconnected between states to facilitate the exchange of information, for example, when device defects are detected. Members also expressed the need for a single European database that readily provides information about medical devices on the market, clinical investigations, EC certificates issued, as well as other relevant information.

The proposal by the European Parliament is only a starting point in the legislative process – how far they go remains to be seen. It is interesting to note, however, the proposals come soon after the FDA touted the superiority of the device regulatory process in the U.S. versus Europe.



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