Medical Device Importer

After Brexit, the UK is no longer required to adopt European medical device regulations. That means the EU MDR and IVDR do not apply, and you must follow the UK Medicines and Medical Devices Act (MMDA). This UK regulation requires you to appoint a regulatory compliance importer for shipments to England, Scotland, or Wales – collectively called, Great Britain.

Regardless of whether you are selling legacy devices holding existing CE certificates under the MDD/IVDD, or devices with CE under the MDR/IVDR, or you already have UKCA marking, you still require a Great Britain importer based in the UK.

As your UK Importer, we can provide the following services:

• Check EUDAMED registration of all economic operators
• Verify that devices placed on the UK/EU market include CE Marking
• Verify that EU declaration of conformity and technical documentation exists
• Verify instructions for use and accompanying information with the device
• Verify labelling includes manufacturer, EC REP, and importer contact details
• Verify that MDR/IVDR storage and transportation requirements are fulfilled
• Maintain a register of complaints as required in Article 13
• Report serious incidents or risks to the competent authority, if applicable
• Maintain traceability of device in the supply chain