London — The European Union has called for tighter regulations surrounding medical device monitoring after weak regulations were blamed, in part, for the recent Poly Implant Prothèse breast implant scandal.
Currently, medical device monitoring is overseen by an ad hoc network of up to 80 national assessment agencies, Reuters reports. The proposal includes a scrutiny panel that would monitor the national agencies’ assessments.
The panel “would have the possibility to pick out medical devices on certain risk-based criteria to decide whether to go into an in-depth analysis of the processes," Reuters quotes EU health commissioner John Dalli as saying.
Eucomed, an industry group that represents nearly 22,500 European medical technology firms, says the plans for the new scrutiny panel procedure would "hamper innovation" and provide no extra safety nets for patients, Reuters reports.
The proposal also includes expanding the legal definition of medical devices to include breast and other aesthetic implants; giving independent assessment agencies greater powers to monitor device manufacturers, including unannounced factory inspections and regular product testing; and better product traceability systems to more quickly alert the public to safety concerns.
EU governments and lawmakers must jointly approve the legislation, which could take up to two years, according to Reuters.
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