Placing medical devices in Great Britain and Northern Ireland: key differences and timelines

The rules for placing medical devices on the Great Britain (GB) and Northern Ireland (NI) markets differ primarily in terms of the timelines and regulatory frameworks: 

Great Britain (GB) Market 

1. Extended Validity of CE Certificates: 

• General medical devices compliant with the EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Devices Directive (EU AIMDD) can be placed on the GB market until the sooner of the certificate's expiry or 30 June 2028.​ 

• In vitro diagnostic medical devices (IVDs) compliant with the EU IVD Directive (IVDD) can be placed on the GB market until the sooner of the certificate's expiry or 30 June 2030.​ 

• General medical devices compliant with the EU Medical Devices Regulation (EU MDR) and IVDs compliant with the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) can be placed on the GB market until 30 June 2030. 

1. Custom-Made Devices: 

• Custom-made devices under the EU MDD or EU AIMDD can no longer be placed on the GB market. They must be registered under UK MDR Part II or Part III.​ 

1. Upclassified Devices: 

• Class I medical devices and general IVDs under the Directives that did not require a notified body can only be placed on the GB market if they now require notified body involvement under the EU MDR or EU IVDR. 

​Northern Ireland (NI) Market 

1. Extended Validity of CE Certificates: 

• CE certificates with extended validity under the EU MDR transitional arrangements are valid for placing devices on the NI market while EU AIMDD and EU MDD CE marked medical devices are accepted on those markets.​ 

• The validity dates for different device classes are aligned with the EU MDR timelines, such as 31 December 2027 for higher risk devices and 31 December 2028 for medium and lower risk devices. 

1. Regulatory Framework: 

• The EU MDR has applied in NI since 26 May 2021, meaning NI follows EU regulations for medical devices.​ 

1. Upclassified Devices: 

• For upclassified Class I devices and Class I reusable surgical instruments, manufacturers must meet specific conditions, including compliance with Directive 93/42/EEC, no significant changes in design and intended purpose, and no unacceptable risk to health or safety. 

​Summary: 

• GB: Follows a transitional period allowing CE marked devices to be placed on the market until specific dates, with custom-made devices requiring UK MDR registration.​ 

• NI: Adheres to EU MDR regulations, with extended validity for CE certificates and specific conditions for upclassified devices.​ 

Manufacturers must update the MHRA Device Online Registration System (DORS) accordingly for both markets, ensuring compliance with the respective regulatory requirements. 

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