Extended recognition of CE marking does not apply to MDs, IVDs

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

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 directiveEU 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.

GOV.UK