News, Policy & Media

02Sep

MHRA Guidance Published on Regulatory Arrangements after Transition Period

 

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released new guidance on the regulatory arrangements for medical devices after the end of the Transition Period (January 2021). Three key aspects are emphasized in the new information. Firstly, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) will not take effect in the UK after the end of the Transition Period, only in EU member states. They will apply from the 26 May 2021 and 26 May 2022 respectively. Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices will continue to apply in Great Britain from 1 January 2021.

 

A new domestic regulatory model for devices will be introduced here in the UK. Engagement with the life sciences and healthcare sectors for this model will take place in the autumn with Government and will be followed by a formal public consultation. Secondly, a new UK product marking will be initiated from the 1 January 2021, applying to medical devices. This will be called the UKCA (UK Conformity Assessed) mark. The guidance found here explains its applicability further. Lastly, CE marking will be recognised until 30 June 2023, regardless of the introduction of the UKCA. This will allow time for the UK route to market to embed and for industry to adapt to these new requirements, ensuring a continued supply of safe devices to UK patients after the transition period.

 

***A webinar will be hosted by the DHSC on these new MHRA guidance points on the 3rd September from 9.30am - 10.30, please register here.***

 

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