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

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 marking [their] own homework” during a panel discussion at the...