The Medical Device Coordination Group (MDCG) has published a Guidance establishing the activities of notified bodies in the verification process of class D IVD devices.…
IVDR progressive roll-out has been officially published!
The Official Journal of the European Union (OJEU) has officially listed the amendment of the In Vitro Devices Regulation 2017/746, extending the transitional period for…
Class D IVDR: Clarification on “first certification for that type of device” by MDCG
The MDCG has endorsed a guidance (updated September 2022) providing clarification on the conditions and corresponding procedures notified bodies need to apply when determining if an expert panel consultation on…