Regulating medical devices in the UK

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance for manufacturers placing medical devices on the United Kingdom market. Following the UK's departure from the European Union, the regulatory framework is primarily governed by the Medical Devices Regulations 2002. The core challenge for industry involves the regulatory divergence between Great Britain and Northern Ireland, as well as the shift from CE marking to the UK Conformity Assessed (UKCA) marking. To maintain market access, all medical devices must be registered with the MHRA. Manufacturers located outside the UK are required to appoint a UK Responsible Person to manage these registrations and act as a formal liaison. While the government has extended the recognition of CE-marked devices until June 2028 or June 2030 depending on the device classification, manufacturers must ensure technical documentation and labeling comply with specific British requirements. In Northern Ireland, devices must continue to follow EU Medical Device Regulations. Furthermore, new legislation effective June 16, 2025, mandates enhanced post-market surveillance and stricter incident reporting. Failure to complete mandatory registrations or appoint a legal representative will result in the inability to lawfully sell products. Organizations must also verify that their UK representatives are correctly recorded in the MHRA system to prevent account suspension and ensure continued supply chain legality.