guide
4th revision of MDCG 2020-16 guidance on the rules for classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746
The Medical Device Coordination Group has just published the 4th revision of the MDCG 2020-16 guidance on the classification rules (...)
Application request for CE marking certification – Regulation (EU) 2017/746
This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)
This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) 2017/745 and also details how to obtain a quote and submit a Formal Application for certification with GMED.