The medical device industry is significantly impacted by Brexit, primarily due to the change in the legal landscape. Notably, the departure by Great Britain from the EU medical device regulatory framework leads to the following:
• Product registration with the UK regulator, the Medicines and Healthcare products Regulatory Agency (“MHRA”), is required for all device classes and is implemented based on device classification.
• A UK Responsible Person will be required for manufacturers based outside the UK.
• The CE mark will be recognized in Great Britain until June 30, 2023 and thereafter a UKCA mark will be required.
• UK-based Notified Bodies are now known as Approved Bodies and will be needed to obtain a UKCA mark for products subject to third party conformity assessment.
• Clinical evidence requirements will differ in Great Britain compared to EU and Northern Ireland for some time once the new EU regulations fully apply. Clinical investigations are affected by the UK’s status as a third country; in particular via the effect on Authorised Representatives. Economic operators and sponsors are advised to be aware of the different requirements for Northern Ireland. Impact is not limited to device-specific regulation, and in relation to data transfers, the UK is now a third country under GDPR. However, until June 30, 2021, data can be freely transferred between EU Member States and the UK. After this date, the provisions of GDPR Chapter V have to be met for such transfers. Other affected areas of importance include intellectual property rights and taxes.
Learn more about what impact Brexit has on the Medtech industry, read the white paper: Brexit – February 2021 – Whitepaper