Dump Scrutiny Procedure, Ratchet Up Oversight of Notified Bodies in Medical Device Regulations, Says Eucomed

January 31, 2013 – 10:26 am

As promised by MedTech Europe CEO Serge Bernasconi in his baptismal blog post earlier this week, Eucomed has published its formal response to the new EU medical device regulations that are before the European Parliament. While Eucomed and industry favour many of the proposed measures, the scrutiny procedure has been a significant bone of contention. In its response, Eucomed proposes replacing article 44 with “more stringent control measures on Notified Bodies.” This would maintain a “predictable and effective regulatory system for patients, healthcare professionals, healthcare systems and innovation,” argues the association.

“The proposed scrutiny procedure is a needle-in-the-haystack approach,” says Bernasconi. The alternative laid out by Eucomed would prevent the needle from landing in the haystack in the first place, he adds.

The scrutiny procedure, as outlined in the new medical device regulations, would subject a number of conformity assessment files for innovative, high-risk devices to an additional central scrutiny process and could add several months to market launch timelines. The comprehensive systematic control procedure advanced by Eucomed to replace article 44 includes measures to guarantee that Notified Bodies meet sufficiently high standards and a mechanism to ensure that clinical evidence related to medical devices is appropriately reviewed by independent clinical experts. It would enhance patient safety without stifling innovation or timely access to life-saving medical technology, says Eucomed.

Eucomed’s response to the European Commission’s proposed medical device regulations also includes recommendations on seven key focal areas.

 Norbert Sparrow

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