New sterilization methods in the GMED’s designation scope under Regulation (EU) 2017/745

GMED (CE 0459) is pleased to inform you about its evolution of scope of its designation as a Notified Body under Regulation (EU) 2017/745.

Indeed, the list of sterilization methods covered by the code MDS 1005 “Devices in sterile condition” now includes hydrogen peroxide (H₂O₂) and liquid chemical sterilising agents.

GMED teams can, therefore, assess certification application relating to medical devices using these sterilization methods.

This new step confirms GMED’s position as one of the notified bodies with the widest scope of designation*.

* The scope of GMED’s designation can be searched on the European Commission’s information system, New Approach Notified and Designated Organizations: NANDO