UK Government has issued a series of new Brexit guidance materials for the life sciences sector. With the transition period coming to an end on 31 December, a period of under four months remains before the Medicines and Healthcare products Regulatory Agency (MHRA) takes on its role as the UK’s standalone medicines and medical devices regulator.
In this article, we discuss the future for medical devices.
Producers of medical devices will face major changes after the end of the transition period. The guidance on medical devices notes that the necessary legislation is not yet in place. This is the Medicines and Medical Devices Bill currently before the UK Parliament.
Points to note:
- CE marking (ie medical devices certified under the EU system) will continue to be used and recognised until 30 June 2023.
- Certificates issues by Notified Bodies in the EU (and EEA) will remain valid until 30 June 2023.
- from 1 January 2021 a new route to market and marking system (the UKCA) will become available for the UK market (excluding Northern Ireland).
- From 1 January 2021 all medical devices and in vitro diagnostic medical devices (IVDs) put on the market in the UK need to be registered with the MHRA. Grace periods of 4 to 12 months are provided for most devices, with the riskier devices benefiting from the 4 month period only.
- A UK Responsible Person will be needed for non-UK manufacturers..
The new EU medical devices legislation (the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR)) will not automatically apply in the UK. Indications on whether the UK intends to adhere to these changes have been inconsistent in recent years. Now the Government proposes to consult with the life science and healthcare sectors, and the wider public, before fixing on a future direction. It is, however, committed to improved standards and scrutiny particularly in light of the Cumberlege Report (discussed here).
Finally, we should point out that there are important differences in the regulatory regimes that will apply in Northern Ireland, due to the separate treatment of Northern Ireland agreed between the UK and the EU in 2019. Separate analysis is needed for activity in the Northern Irish market.