16 Feb 2021
Written By Ruth Neale, Programme Manager, Longitude Prize and Gill Morgan, Regulatory consultant
The Brexit transition period has ended and the UK has left the European Union (EU). Whether you were celebrating, sobbing, or totally indifferent to this event on 31 December 2020, one thing is for sure is that the official bureaucratic rules and formalities that govern and safeguard everything from food produce to product development related to the UK also changed. From now on in terms of regulation there are different rules for Northern Ireland and what is referred to as Great Britain (GB) which includes England, Wales and Scotland. GB will make its own rules while Northern Ireland, will be different – given it shares a land border with the Republic of Ireland, a country in the EU single market.
So, how have the regulatory requirements for in vitro diagnostic devices (IVDs) changed, post-Brexit? And, what do these changes mean for med-tech developers in the race to win the Longitude Prize?
Up until June 2023, the Medicines and Healthcare Regulatory Agency (MHRA) will continue to recognise CE Marks and the certificates issued by European Economic Area-based Notified Bodies. Therefore, diagnostic developers can still place CE Marked devices on the GB market until 30 June 2023.
From 1 July 2023, an IVD must bear the UK Conformity Assessment Mark (UKCA) in order to be placed on the GB market and the CE Mark will no longer be recognised. It should be noted that from this date, IVDs may carry both the UKCA Mark and the CE Mark; however the UKCA Mark is compulsory.
Between 1 January 2021 and 30 June 2023 IVDs that bear the CE Mark or the UKCA Mark may be legally sold or placed in Great Britain.
From January 2021, the MHRA has set-up UK Conformity Assessment Bodies. Those bodies, called CABs for short, will assess if products meet the UKCA mark requirements.
Given the final deadline for submitting an application to win the Longitude Prize is September 2022, there is no immediate need for Longitude Prize teams to obtain the UKCA Mark to access the GB market.
However, some of the longer-term implications remain undecided and regulations in place may evolve over the duration of the Longitude Prize competition. The UK is currently governed by the Medical Device Regulation issued in 2002 taking into consideration all subsequent amendments.
Longitude Prize teams may continue to develop their devices for CE Marking in line with the IVD Regulation 2017/746. Our current understanding of the UK regulation would suggest that the data generated to CE Mark the IVD will be sufficient for the UKCA Mark. It is important however that the clinical and device performance data has taken the UK population into consideration when selecting samples or study subjects.
If a developer wants their device to be sold and available in the EU, then by default the Northern Ireland (NI) market will be included. The device will need to be CE Marked in order to be placed on both the EU and the NI markets.
Depending upon the intended use of the device, for EU registration, a Longitude Prize device is likely to be Class B or Class C under the IVD Regulation 2017/746 and will need a Notified Body to review their data and documentation. This Notified Body must be located within Europe including the Republic of Ireland.
A transition period has been allowed for manufacturers to complete this conformity assessment that will end on 30 June 2023. Between 1 January 2021 and 30 June 2023 IVDs that bear the CE Mark or the UKCA Mark may be legally sold or placed in Great Britain.
For a manufacturer who is based outside of the UK, from 1 January 2021 they will need a Responsible Person based within the UK who will complete all the necessary registration work for the manufacturer and the details of the Responsible Person must be on the device label. All devices must be registered with the MHRA prior to placing on the market anywhere within the UK.
A manufacturer who is based outside Europe and the UK will need an Authorised Representative for the CE Marking and the details of the Authorised Representative must be on the device label.
As part of their long-term business strategy, a Longitude Prize team who is based outside of Europe and the UK will need to carry both Authorised Representative and Responsible Person details to access the Europe (including Northern Ireland) and GB market.
To the best of our knowledge, if a review by a UK Conformity Assessment Body (CAB) is needed for the UKCA mark, it is unlikely to be longer than the review period for CE Mark by Notified Bodies (~ 3 months for a high quality submission).
Current expectation is that Longitude Prize teams should be able to self-certify their UK Conformity Assessment (UKCA) for the GB market and therefore will be able to control their own timeline. If the test is a self-test, a CAB will be required.
If you have any questions or you’d like to find out more, please submit your questions!
Please submit questions you may have to [email protected] and we will respond by email and publish them here for the Longitude Prize community.
Congratulations to the winners of the Longitude Prize on AMR, Sysmex Astrego!
