Updated Registration Guidance for Reusable Class I and Upclassified Medical Devices in the UK

Regulatory Update:
The UK has extended the validity of CE certificates for medical devices under the EU Medical Device Regulation (MDR) transitional arrangements, allowing continued market access in Great Britain (GB) and Northern Ireland (NI).

Key Deadlines for CE Certificate Validity:

Higher-Risk Devices (Class III & Class IIb Implantable Devices): Valid until 31-Dec-2027.
Medium & Lower-Risk Devices (Class IIb, IIa, Im, Is, Ir): Valid until 31-Dec-2028.
Market Access & Compliance Requirements:

GB Market: CE-marked devices can be placed on the market until 30-Jun-2028 (general medical devices) and 30-Jun-2030 (in vitro diagnostic devices – IVDs).
NI Market: Devices remain eligible under the transition periods outlined in Article 120(3a) of the EU MDR.
Manufacturer Responsibilities:
Update the MHRA Device Online Registration System with extended CE certificate documentation.
Strengthen post-market surveillance to ensure continued compliance.
Certificate Validity Conditions:

Issued under the EU Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) after 25-May-2017.
Must have been valid until 26-May-2021 before transitioning to MDR compliance.
Manufacturers must submit required documentation to maintain validity.
This update ensures continued access to medical devices while reinforcing safety and compliance in the UK healthcare market.

Region: European Union

Source: https://www.gov.uk/government/publications/registration-of-reusable-or-upclassified-class-i-devices-andor-expiring-ce-certificates/registration-of-certain-medical-devices-which-are-reusable-class-i-devices-upclassified-class-i-devices-andor-reliant-on-expiredexpiring-ce-certif