Notified Bodies Must Be Involved In EU Joint HTA Discussions, Urges BSI Clinical Compliance Lead

The EU Regulation on HTA will see some medtech manufacturers offered scientific advice on planned clinical investigations. According to BSI’s global head of clinical compliance, MDR/IVDR notified bodies can offer valuable expertise and must not be left out of these discussions.

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As independent, third-party assessment organizations notified bodies designated under the EU Medical Device and IVD Regulations are prohibited from providing feedback to manufacturers during the conformity assessment process.

This makes sense, according to BSI’s global head of clinical compliance Richard Holborow, who remarked that notified bodies “shouldn’t be...

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