MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published a template of the clinical evaluation report, accompanied by guidance intended to provide device manufacturers and other parties involved with the additional...
The Medical Device Coordination Group (MDCG), an advisory body composed of representatives of all Member States who are focused on the improvement of the existing regulatory framework, recently issued guidance dedicated to medical devices containing ancillary...
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, focused on the improvement of the medical devices` regulatory framework, published regulatory requirements for ventilators and related accessories. Regulatory Background ...
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused at the improvement of the medical devices regulatory framework, issued a guidance document on clinical evidence for medical devices already marked with the CE marks under...
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of the EU Member States` representatives and focused on the improvement of the medical devices regulatory framework, issued guidance documents for medical device...
COVID-19
The Medical Device Coordination Group (MDCG) issued guidance on audits and conformity assessment procedures to be carried on by the notified bodies in the context of the outbreak of Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel...
