Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the UK leaving the EU will affect the way in which medical technology is regulated in the UK; and what assessment he has made of the potential effect of the UK leaving the EU on the ability of UK citizens to travel abroad with dialysis machines.

The Government is committed to the safe and effective regulation of medical devices in the United Kingdom. We continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.

Subject to the ratification of the Withdrawal Agreement, there will be a two-year Implementation Period, during which the Medicines and Healthcare products Regulatory Agency (MHRA) would continue to be recognised as a European Union competent authority designated under the EU Directives for medical devices, and the regulatory framework would operate as it does now. Arrangements beyond the implementation period are subject to further negotiation.

In a ‘no deal’ scenario, the UK’s current participation in the European regulatory network for medical devices would end, and the MHRA would take on the responsibilities for the UK market that are currently undertaken through the EU system.

The UK is seeking bilateral agreements with individual Member States to secure the continuation of existing arrangements or the establishment of comparable ones.

In the meantime, the Government continues to advise people who require treatment for pre-existing conditions, including dialysis users, to seek the advice of their doctor or specialist unit before making travel arrangements. They should also contact the chosen specialist administrator in their destination to ensure treatment received after 29 March 2019 would not be affected by a ‘no deal’ scenario.