On 8 October the UK Government issued its “No Deal Readiness Report”. Whilst it is not yet known whether the UK will leave with or without a Withdrawal Agreement at the end of October, the report sets out guidance for industry across a range of sectors – including providers of medicines and medical devices.
Guidance can be found via the link here. Please see page 83 to 85 for guidance on Medical Devices and page 95 – 97 for guidance on Medicines.
In summary – in respect of Medical Devices, if there is no deal:
- The Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK market currently undertaken through the EU regulatory system
- The UK’s current participation in the European regulatory network for medical devices would end
- The Government has chosen to continue recognising medical devices that are approved for the EU market and CE-marked. If this changes, the Government will give at least two years’ notice to manufacturers to implement any new requirements
- Relevant labelling requirements will continue to apply, including the requirement for products to carry a CE mark and their notified body number (for devices which currently require conformity assessment).
- The Government will give UK-based notified bodies official status under domestic legislation and will continue to recognise the validity of certificates that they issued before 31 October 2019. This will allow products covered by certificates issued by UK-based notified bodies to continue to be placed on the UK market after 31 October 2019.
More detailed Government guidance is available here: https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario#ce-marking-your-devices-and-conformity-assessment.
The Government has taken a pragmatic approach regarding batch testing and certification and made provisions to recognise batch testing from EU and EEA countries, and those countries with which the EU has a Mutual Recognition Agreement.
More detailed government guidance is available here: https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal