New MHRA Guidance concerning extended periods of validity of CE Certificates and Declarations of Conformity for some in vitro diagnostic medical devices

Reflecting the 2024 revisions to the EU in vitro diagnostic Medical Devices Regulation, the UK MHRA has published a legislation extending acceptance of CE-marked in vitro diagnostic medical devices (IVDs) on the Great Britain (GB) market (Registration of certain in vitro diagnostic devices - GOV.UK). This step is intended to ease the transition to the future regulatory framework and to enable the ongoing safe supply of IVDs to GB. Validity of Certificates and Declarations is extended as follows:

The validity of CE Certificates of Conformity issued from May 25 ,2017 that were still valid on May 26, 2022 has been extended, to:

·    December 31, 2027 for Annex II List A, Annex II List B, and Self-test devices

The validity of Declarations of Conformity drawn up prior to May 26, 2022 has been extended, to:

·    December 31, 2027 for General IVD devices that have been upclassified to Class D IVD devices

·    December 31, 2028 for General IVD devices that have been upclassified to Class C IVD devices

·    December 31, 2029 for General IVD devices that have been upclassified to Class B IVD devices and for class A devices placed on the market in sterile condition

The Guidance adds that notified bodies are not required to change the date on the individual certificates.