UK Extends Acceptance of CE Marked Medical Devices

The UK government has made changes to the UK MDR (2002) to extend the acceptance of CE marked medical devices on the Great Britain market. Those amendments will enter into force on 30 June 2023. (full legal text: The Medical Devices (Amendment) (Great Britain) Regulations 2023 (legislation.gov.uk)).  

Under the new amendments, the timelines for placing CE marked medical devices on the UK market are as follows: 

• • Medical devices compliant to the EU MDD or EU AIMDD can be placed on the market until the earlier of the certificate’s expiry or 30 June 2028. 

  • IVDs compliant with the EU IVDD can be placed on the market until the earlier of the certificate’s expiry or 30 June 2030. 

  • General medical devices, including custom-made devices, compliant with the EU MDR, and IVDs compliant with the EU IVDR can be placed on the market until 30 June 2030. 

The new legislation allows certain CE marked medical devices to be available on the Great Britain market for a longer period. 

For self-declared CE marked Class I medical devices, the legislation allows them to be placed on the market beyond 30 June 2023 if they meet the following conditions: 

• • Self-declared against EU MDR requirements until 30 June 2030. 

  • Self-declared against EU MDD but which have been up-classified (some SaMD or reusable) until 30 June 2028.  

It also provides that you can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028. 

Class I medical devices and general IVDs that didn’t require the involvement of a notified body under the MDD or IVDD can only be placed on the Great Britain market if notified body involvement is required under the EU MDR or EU IVDR.  

Custom-made devices compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market. 

Manufacturers cannot rely on expired certificates when placing medical devices on the Great Britain market under these transitional measures unless such certificates have been deemed valid by the EU. 

Additionally, the government plans to introduce legislation in 2023 to strengthen post-market surveillance requirements, emphasizing patient safety. These requirements are expected to take effect from mid-2024. 

Read Full Amendment Here