Europe – MDCG 2022-17 – MDCG position paper on ‘hybrid audits’

This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – European Regulators Move to Increase Notified Body Capacity

The European Commission (EC) has taken new measures to relieve some of the pressure on Notified Bodies and free up capacity to perform medical...

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