Notified bodies are being punished with a non-conformity during surveillance audits by member state authorities for not applying the requirements detailed in guidance documents. That is what Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV-SÜD notified body, told the MedTech Forum last week.
These guidance documents, drafted in the context of the EU Medical Device Regulation by the European Commission’s Medical Device Coordination Group (MDCG), are not legally binding, she asserted.