EU Exit - Research Governance Information
When the UK leaves the EU single market and customs union at the end of the transition period on 31 December 2020 there will be regulatory changes within the UK, however the Human Tissue Act 2004 will not be affected.
Establishments that are licensed under the Human Tissue Act 2004 will not require changes to their HTA licence following the end of the Transition Period.
If you obtain biosamples for analysis to provide data for a clinical trial, please see FAQs on HTA licensing requirements for human tissues and cells used in clinical trials and medicines.
Transfer of personal data to countries outside of the UK:
The UK Government has made a Decision of Adequacy in relation to the data protection regulations in the EEA. The principles and rules for transfer of personal data to research partners or data processing firms in the EEA* will therefore not change after Brexit.
Transfer of personal data to the UK following Brexit:
As a Brexit agreement has been reached with the European Union, a part of this agreement will be an ‘Adequacy Decision’ from the EU in relation to UK data protection, i.e. a decision that UK law offers equivalent protections to that of European data protection law. However, at present, the EU have up to 6 months to reach this decision and therefore in the meantime the following guidance has been issued in relation to the transfer of personal data Please refer to the paragraph of information under the sub heading of 'Data'.
Transfer of personal data from the EEA to the UK will therefore be able to continue at the moment. However, researchers will still be required to clarify for research participants the specific data protection law under which their personal information is being collected, processed and stored. They will also be required to seek explicit consent from research participants to share their information with researchers in other institutions. To do this researchers should continue to use the DPA 2018 compliant participant information sheet and consent form templates for their studies as these have been modified to make it clear that the collection, process and storage will be in accordance with UK data protection laws.
* This also includes those countries for which the EU has issued an adequacy decision, e.g. New Zealand, Argentina and others.”
Further information can be found on the Information Governance Office's website: https://www.staffnet.manchester.ac.uk/igo/data-protection/data-protection-and-brexit-/
MHRA-related guidance can be found on their website under MHRA post-transition period information
Drug Trials: Specifically for CTIMPs – Preparation of the Clinical Trial Application form for the MHRA will be via IRAS from 1 January 2021; with submission of the application via the new MHRA Submissions system. (You will still need a EudraCT number, at least in the short term).
The following links may also be helpful:
- MHRA Guidance on substantial amendments to a clinical trial from 1 Jan 2021 (this details requirements for EU legal representatives and IMP certification).
- MHRA guidance on Registering CTIMPs and publication of summary results.
- MHRA Webinar on Clinical Trials (recorded 21 October).
Medical Devices – Clinical investigations of medical devices will continue to be submitted via IRAS post-transition.
If you are in a position to market your device before 30 June 2023, you may wish to comply with EU Medical Devices Regulation (EU MDR) or EU in vitro Diagnostic Regulation (EU IVDR) in order to market in both the EU and UK. EU Notified bodies and CE marking will continue to be recognised by the MHRA up to this date.
From 1 July 2023 Great Britain will diverge from the EU Regs (NI will continue to align with EU). MHRA plan to consult widely on the new regulatory regime for Great Britain.
From next year, manufacturers will need to register all medical devices for the UK market with the MHRA, timelines depend on class. Learn more at: regulating medical devices from January 2021. You may also find the MHRA Webinar on Devices (recorded 21 October) helpful.
Meanwhile, the UK Medicines and Medical Devices Bill 2019-20 (the statutory vehicle that will enable the UK to have a new regulatory regime), continues to progress through the House of Lords, learn more about progress of the bill.
The UK will remain signatory to the Nagoya Protocol. Please see the Research Governance Team’s webpages for details about compliance with the Nagoya Protocol.