Registration of Specific Medical Devices in the United Kingdom

As of February 2025, new medical device registration rules apply in the United Kingdom. These changes ensure full compliance with UK MDR 2002, specifically affecting:
• Reusable Class I medical devices.
• Reclassified medical devices under MDR.
• Devices relying on expired or soon-to-expire CE certificates.

Who is Affected by the New Regulations?

The updated requirements apply to manufacturers, importers, and authorized representatives operating in the UK market. To legally sell products in the UK, registration with the MHRA database is mandatory.

Registration Process

To comply with the new requirements, manufacturers must:

• Register their devices in the MHRA system before placing them on the market.
• Submit complete technical documentation in accordance with UK MDR 2002.
• Have an authorized representative in the UK if the company is not based there.

Consequences of Non-Compliance

Companies failing to meet the registration requirements may face administrative penalties, and their products could be withdrawn from the market. The MHRA will conduct regular inspections to enforce compliance.

Conclusion

The new medical device registration requirements in the UK aim to enhance market safety and transparency. Manufacturers are advised to adapt as soon as possible to avoid the risk of product removal.

More information available on the MHRA website