European Union, United Kingdom - January 31 2023
The EU introduced a complete revamp of its medical device regulatory framework back in 2017. The new regulatory framework consists of the Medical…
Xisca Borrás
European Union, United Kingdom - November 28 2022
At the Plenary session of the European Parliament on 24 November, European Commissioner for Health and Food Safety, Stella Kyriakides, indicated that…
European Union, United Kingdom - November 17 2022
The Medical Device Coordination Group (MDCG) in the European Commission has, unexpectedly, announced an extraordinary meeting, to be held on 17…
European Union, United Kingdom - November 15 2022
In yet another setback to the UK's implementation of an independent regulatory framework following Brexit, the government has once again delayed the…
United Kingdom - October 26 2022
On 17 October 2022, the MHRA published its “roadmap” for a future regulatory framework for software and AI as medical devices (SaMD and AIaMD…
Christopher Bates, Alex Denoon