EU proposes tougher device rules in light of implant scandal

On the heels of Europe's faulty silicone breast implant scandal, the European Union is proposing to tighten regulations on medical devices around the continent.

For starters, the EU wants to expand its definition of medical devices to include aesthetic implants, like the faulty silicone ones unmasked in the Poly Implant Prothese scandal, Reuters reports. Otherwise, the EU proposes to expand the powers of independent regulators, allowing them to conduct random inspections of device manufacturers and regular product testing. The government also wants to focus on traceability, giving physicians and patients easier access to information on device failures.

As it stands, medical devices in Europe are regulated by an ad hoc network of about 80 agencies, many of which are private companies, Reuters notes. That setup allows things like faulty breast implants to slip through the cracks, EU Health Commissioner John Dalli told the news service, and tightening regulations will lead to better patient outcomes.

The proposal follows a similar one made by the European Parliament over the summer, and Eucomed, an EU trade association for biotechnology companies, balked at the idea of stricter device regulations, saying it would lead to "years of delay in the availability of medical technology solutions to European citizens."

As Reuters points out, the proposed new rules would require joint approval of the EU's governments and lawmakers, a process that could take about two years.

- read Reuters' story

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