What are the requirements for registering medical devices with MHRA?

To register medical devices with the MHRA, manufacturers must follow specific requirements and procedures. 

​Here are the key steps and requirements: 

1. Access the MHRA Device Online Registration System (DORS): 

• Manufacturers need to create an account and log in to the MHRA Device Online Registration System (DORS). ​ 

2. Upload necessary documentation: 

• For devices with expired or expiring CE certificates, manufacturers must upload the appropriate documentation, such as:  

• A letter from the notified body confirming the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. ​ 

• A declaration that the certificate remains valid under EU MDR Article 120, using the provided template if necessary. ​ 

3. Select certificate type and validity date: 

• On the Conformity Assessment Certificate page, manufacturers must:  

• • Upload the expired or expiring CE certificate.
  • Select the correct certificate type.
  • Enter the appropriate extended CE certificate validity date from the provided tables (Annex A).
  • Enter the CE certificate reference number.
  • Select the appropriate EU notified body designation and name.  

4. Follow specific scenarios: 

• Depending on the status of the device and certificate, manufacturers must follow specific steps outlined in the guidance:  

• • Scenario 1: For devices already registered with MHRA with expired certificates before 20 March 2023. ​ 
  • Scenario 2: For devices not yet registered with MHRA with expired certificates before 20 March 2023.
  • Scenario 3: For devices already registered with MHRA with certificates expiring on or after 20 March 2023.
  • Scenario 4: For devices not yet registered with MHRA with certificates expiring on or after 20 March 2023.
  • Scenario 5: For EU MDD Class I medical devices upclassified under EU MDR or Class I reusable surgical instruments already registered with MHRA.
  • Scenario 6: For EU MDD Class I medical devices upclassified under EU MDR or Class I reusable surgical instruments not yet registered with MHRA. 

5. Update device registration: 

• Manufacturers must update the device registration in DORS, including unlinking expired certificates and uploading new documentation as required. ​ 

6. Compliance with EU MDR and UK MDR: 

• Ensure that the devices comply with the relevant EU MDR and UK MDR requirements, including maintaining a quality management system and meeting conformity assessment procedures. ​ 

By following these steps and meeting the outlined requirements, manufacturers can successfully register their medical devices with the MHRA and ensure compliance with regulatory standards. 

​Source: Registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates - GOV.UK