The first module of the EU medical device database, EUDAMED, is up and running. However, because actor registration is voluntary until 26 May 2022, when the complete database is planned… Read More
Month: January 2021
Additional MHRA guidance for medical device companies
Several guidance documents have been published by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2020 and subsequently, including guidelines on the UK Responsible Person (UKRP) and UK… Read More
mdi Europa experience on MDR technical documentation reviews
Under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), EU Authorized Representatives are – among others – in charge of… Read More