The UK Competent Authority (MHRA) shared today some important insights with specific deadlines on how it shall regulate medical devices after 1 January 2021. The presented proposals will take effect through legislative changes introduced later this year, and are therefore still subject to parliamentary approval.
Firstly, there is a particular mention of (non) applicability of the MDR and IVDR on the territory of Great Britain after the transition period ends. In this regard, the MHRA indicates the development of its own regulatory framework:
“As these regulations [EU MDR/IVDR] will not take effect until after the transition period with the EU has ended…will therefore not automatically apply in Great Britain.”
”We have the opportunity to develop a robust, world-leading regulatory regime for medical devices that puts patient safety at the heart of the regulatory system. We will take into consideration international standards and global harmonisation in the development of our future system…. This will be followed by a formal public consultation with the aim of delivering an attractive world-class regulatory system.”
Nevertheless, the EU MDR and IVDR will apply in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline.
Here below we share some relevant points and deadlines from the MHRA concerning the market of Great Britain:
- CE marking will continue to be used and recognised until 30 June 2023;
- From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking;
- Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023;
- This will include devices placed on the market that conform with the EU MDR or EU IVDR.
- A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021;
- From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
- 4 months for Class III and Class IIb implantables, and all active implantable medical devices + IVD List A (until 30 April 2021)
- 8 months for other Class IIb and all Class IIa devices + IVD List B, self-test IVDs (until 31 August 2021)
- 12 months for Class I devices + General IVDs (until 31 December 2021)
- If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK.
- As of 1 January 2021, medical devices placed on the Great Britain market will need to have either a UKCA mark or a CE mark, depending on which legislation the device has been certified under.
As well as an important remark on the conformity assessment for the EU market:
- The results of mandatory conformity assessment carried out by UK Notified Bodies (Approved Bodies) will not be recognised by the EU. This is the case even if the assessment is carried out before the end of the transition period, unless the product has already been placed on the EU market before 1 January 2021.
Further details can be found on on the UK MHRA website.