The MHRA has published further guidance with regards to regulatory requirements for Medical and In-Vitro Diagnostic devices in Great Britain.

The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) is the formal title of the regulations adopted by the United Kingdom. This transposed the In Vitro Diagnostic Directive (98/79/EC) (IVDD) and Medical Device Directive (93/42/EEC) (MDD) into a UK specific regulation.

The deadline for all devices to comply with the UK MDR 2002 was set to come into force in June 2023. This deadline has been extended for many medical and in-vitro diagnostic medical devices.

General medical devices compliant with the EU MDD with a valid declaration of conformity and CE Marking can be placed on the market until 30 June 2028.

In vitro diagnostic medical devices (IVD’s) complaint with the IVDD can be placed on the market until the expiry date of certificate or 30th June 2030.

General medical devices, including custom made, compliant with the The European Medical Device Regulation (EU MDR 2017 745) (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), can be placed on the Great Britain market until 30 June 2030.

NOTE

Class I devices and General IVD’s under the MDD / IVDD or MDR / IVDR that do not require a Notified Body will no longer be able to be places on the Great Britain market from June 2023. This means they must comply with the Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) in order to be places on the market.

All devices must be on the market before 1st July 2025 as CE Certificates will not be renewed after this date. As of yet we do not know what the ‘NEW’ requirements will be.