Government response

CE marking recognition for medical devices and in vitro diagnostics

The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 1 August 2023

The extended recognition of CE marking announced this morning does not apply to medical devices or IVDs.

The government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. More specifically, legislation now enables CE marked medical devices to be placed on the Great Britain market to the following timelines:

• general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2028
• in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2030, and
• general medical devices, including custom-made 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 Great Britain market up until 30 June 2030.

For further information, please see the latest update on the implementation of the future regulations for medical devices.

Published 1 August 2023