The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals.
A 10-week consultation launched by the UK’s Medicines...more
The agreement provides guidance across several areas for the life sciences sector, though gaps remain.
The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more
3/4/2021
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UK Brexit
The MHRA offers new guidance on how medical devices will be regulated in the UK from 1 January 2021.
On 1 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical...more
European Commission proposes one-year postponement in light of the COVID-19 crisis.
On 25 March 2020, the European Commission announced that it was working on a proposal to postpone the date of application for the new EU...more
Companies should act now to prepare for the full implementation of the MDR and IVDR.
On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more