On September 1, 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) published new rules to be respected for placing and the registering a medical device on the UK market, from 1 January 2021.
The guideline is indicative and not definitive, as a new legislation will have to obtain parliamentary approval.
Which are the most significant points of the guideline?
- MHRA will continue to be the central authority for the supervision and the responsibilities of the UK medical device market. From 1 January 2021 any medical device, IVD or custom device will have to be registered with the MHRA before being placed on the UK market. According to the risk class of the device, different grace periods are provided to allow compliance with the new registration process.
- From 1 January 2021 the Authorized Representatives established in Great Britain will not be recognised in the EU.
- From 1 July 2023, it will be necessary to meet the requirements for placing the UKCA (UK Conformity Assessed) mark to place a device on the UK market.
- From 1 January 2021 the Manufacturer, based outside the UK, will need to designate a UK Responsible Person (UKRP) based in the UK that will assume the responsibility of the Manufacturer in terms of device registration at MHRA.
- The CE marking will continue to be used and recognised until 30 June 2023, as well as the CE mark certificates issued by Notified Bodies established in the European Economic Area (EEA).
- From 1 January 2021, devices intended for the EU market must present the CE marking to demonstrate compliance. It will not be possible to enter the device on the market if mandatory third-party conformity assessment has been conducted by a UK Notified Body. Meanwhile, if the device is placed on the EU market before 1 January 2021, in accordance with the terms of the Withdrawal Agreement, it may remain on the EU market.
Thema Staff follows the updating to offer in short times complete strategic-regulatory consulting services for what concerns the relevant new regulations as a result of Brexit.
There is not much time left to nominate your UK Responsible Person. The deadline is January 1, 2021! Contact us for more information.