Medical device registration in Great Britain and Northern Ireland

Registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates in Great Britain (GB) and Northern Ireland (NI).

The document provides detailed guidance on the registration of certain medical devices in Great Britain (GB) and Northern Ireland (NI), particularly focusing on reusable Class I devices, upclassified Class I devices, and devices reliant on expired or expiring CE certificates.

​ Key points include:

1. Extended Validity of CE Certificates: The EU has extended the validity of certain CE certificates under the EU Medical Devices Regulation (EU MDR) transitional arrangements.

​ Higher risk devices (Class III and Class IIb implantable devices) are valid until 31 December 2027, and medium and lower risk devices (Class IIb non-implantable, Class IIa, Class Im, Is, and Ir devices) are valid until 31 December 2028.​

1. GB Market: CE marked medical devices can be placed on the GB market until the sooner of the certificate's expiry or 30 June 2028 for general medical devices, and 30 June 2030 for in vitro diagnostic medical devices (IVDs).​
2. NI Market: CE certificates with extended validity are valid for placing devices on the NI market while EU AIMDD and EU MDD CE marked medical devices are accepted on those markets.​
3. Registration Process: Detailed steps are provided for manufacturers to update the MHRA Device Online Registration System (DORS) for devices with extended CE certificate validity, including scenarios for devices with expired certificates and those not yet registered with MHRA.​
4. Upclassified Devices: Specific requirements for upclassified Class I devices and Class I reusable surgical instruments under EU MDR are outlined, including conditions for continued reliance on EU MDD declarations of conformity.​
5. Annex A: Provides a table with extended validity dates for different device classes for both GB and NI markets.​

The document emphasizes the importance of updating the MHRA registration system to reflect the extended validity of CE certificates and provides templates and detailed instructions for compliance.

​Source: Read full document here.