UK Regulators Update Guidance on IVD Registrations with Expiring CE Certificates

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on registering certain in vitro diagnostic (IVD) devices reliant on European compliance, expired or expiring CE certificates or declarations of conformity.

New IVD device guidance

In alignment with the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) Article 110 transitional arrangements, the MHRA has published legislation to extend acceptance of CE-marked IVDs on the Great Britain (GB) market to enable the ongoing safe supply of IVDs to GB and to ease the transition to the future regulatory framework. Subject to meeting certain conditions, the newly introduced measures allow CE-marked IVDs compliant with the EU IVDD to be placed on the GB market up until the extended expiry dates detailed below:  

• EU IVDD CE certificates for Annex II List A, Annex II List B, and Self-test IVDs extended until 31 December 2027
• EU IVDD Declaration of Conformity for General IVDs that have been up-classified to Class D valid until 31 December 2027
• EU IVDD Declaration of Conformity for General IVDs that have been up-classified to Class C valid until 31 December 2028
• EU IVDD Declaration of Conformity for General IVDs that have been up-classified to Class B valid until 31 December 2029

Note 1: IVDs classified as general under the IVDD legislation for which the conformity assessment did not require the involvement of a notified body (NB), can only be placed on the GB market if the involvement of a NB is required under the EU IVDR (i.e. if it is up-classified).

Note 2: EU IVDR-compliant devices can be placed on the GB market until 30 June 2030.

Impact on registrations

For devices for which the CE certificate extension is valid, the MHRA encourages the manufacturer, or their United Kingdom Responsible Person (UKRP), to update the MHRA Device Online Registration System (DORS), and to support this, guidance detailing the impact on registration and managing registered devices has been published. This guidance provides direction for six scenarios regarding devices already registered with the MHRA and devices not yet registered with the MHRA, for CE certificates that expired before 9 July 2024, for CE Certificates expiring on or after 9 July 2024, and for EU IVDD General IVDs that are up-classified under EU IVDR and require NB involvement. An Article 110 extension confirmation template is also provided.

Updates related to medical devices

In addition, the MHRA has made minor updates to the current guidance document Registration of certain medical devices which are reusable Class I devices, up-classified Class I devices, and/or reliant on expired/expiring CE certificates.

Emergo by UL is here to help

The MHRA appears to be starting 2025 as it ended 2024 — with further progression of the UK medical device legislation and closer alignment to the EU. Emergo by UL consultants in the UK and Europe will provide additional updates on the UK medical device and IVD regulatory landscape as changes become available.