EU Parliament Considers More Stringent Medical Device Regulations
This article was originally published in The Gray Sheet
EU Parliament committee continues debate on medical device regulations, focusing on pre-market approval, scrutiny of notified bodies and post-market surveillance.
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A key legislator on device reform in the European Parliament has issued a strong call to establish pre-market authorization for high-risk devices in Europe, among other consequential regulatory changes.
The Committee held a workshop Feb. 26 to address a proposal issued last year by the European Commission to impose reforms on EU device oversight. Some members of Parliament and others in Europe believe the proposal may not go far enough when it comes to pre-market oversight.
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