101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 141 UK-based Notified Bodies would, in a ‘no-deal’ scenario, no longer be able to assess the conformity of medical devices for devices to receive the CE mark and enter the EU market. Therefore, the MHRA will no longer be able to oversee Notified Bodies in the way that it does now. Post market surveillance of devices Currently, post-market safety data is shared across all members of the European regulatory network for devices (EU, EEA, Turkey and Switzerland), and any disagreement over the marketing of a device can be escalated through regulator forums such as the Medical Devices Coordination Group, and potentially through the European Commission and Court of Justice of the European Union. If there’s ‘no deal’, the MHRA would continue to perform national post-market surveillance of medical devices on the UK market, and able to take a national decision over the marketing of a device in the UK, regardless of the position of the European regulatory network, or any decision of the CJEU. Clinical Trials Clinical Trial applications As clinical trials are currently managed nationally, UK clinical trial applications will continue to be authorised by the MHRA and ethics committees as they are now. The UK ability to participate in multinational trials will also not change. MHRA will be improving processes to enable closer working with ethics bodies and allowing a single application and a single national decision in the UK. The initial pilot work has started and would continue to be developed post-exit. Legal presence At present, a sponsor or their ‘legal representative’ should be based in the EU or EEA; we’re seeking to preserve this position if there’s ‘no deal’. While the legal representative will only need to be based in the EU or EEA we anticipate it will be necessary to have an individual based in the UK who has overall responsibility for the trial and can be contacted to discuss urgent issues arising in connection with a trial, for example urgent safety matters or trial suspensions. We’ll provide more information in due course. Transparency Our intention is to align UK transparency provisions with those currently operating in the EU. Information on how a UK system would be developed will be the subject of consultation.