MHRA registration updates: What they mean for your medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance outlining how recent EU regulatory changes affect the registration of medical devices in Great Britain.

Mike Picchioni, Associate Director of Regulatory Affairs, at G&L Scientific, examines the impact and implications of the changes.

Introduction

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance outlining how recent EU regulatory changes affect the registration of medical devices in Great Britain.

This update is particularly relevant for manufacturers of:

• Reusable Class I devices
• Upclassified Class I devices
• Devices relying on expired or expiring CE certificates

The guidance, released on 17 February 2025, explains how to navigate these changes using the MHRA’s Device Online Registration System (DORS). As timelines under the EU Medical Devices Regulation (EU MDR 2017/745) shift, understanding the implications for UK registrations is critical.

Revised EU timelines

The EU has extended the validity of CE certificates issued under the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD), enabling continued market access for longer, under specific conditions.

The extended validity applies as follows:

• Until 31 December 2027 for higher-risk devices (Class III and Class IIb implantable devices), excluding certain well-established technologies such as screws and sutures.
• Until 31 December 2028 for medium- and lower-risk devices (other Class IIb, Class IIa, and Class Im/Is/Ir devices).

For certificates that expired before 20 March 2023, they may still be considered valid if:

• The manufacturer had signed a written agreement with a notified body for the conformity assessment before the expiry date; or
• A competent authority granted a derogation (Article 59) or a period for assessment (Article 97) under EU MDR.

Full details of the legislation can be found here: EUR-Lex - 32023R0607.

The GB market: What still applies

Manufacturers placing medical devices on the GB market under transitional arrangements must meet specific timelines and conditions.

Devices with extended validity under the EU MDR transitional provisions (Article 120) may continue to be placed on the GB market, but only while EU AIMDD and EU MDD CE-marked devices are still accepted.

The MHRA has confirmed the following timelines:

• General medical devices (EU MDD or EU AIMDD): Until the sooner of certificate expiry or 30 June 2028.
• IVDs (EU IVDD): Until the sooner of certificate expiry or 30 June 2030.
• Devices compliant with EU MDR or EU IVDR: Until 30 June 2030.

Class I devices and general IVDs that previously didn’t require a notified body under the Directives can only continue to be placed on the GB market if they now require notified body involvement under the EU MDR or EU IVDR (i.e., if they are upclassified).

Custom-made devices can only be placed on the market under UK MDR Part II or Part III (which is currently consistent with EU medical devices directive requirements) with a suitable accompanying custom-made statement.

Manufacturers cannot rely on expired CE certificates unless they have been deemed valid under Article 120. All updates must be reflected in the MHRA DORS system.

Registering devices with previously expired certificates

To register a device based on an expired CE certificate (valid on 26 May 2021 and expired before 20 March 2023), manufacturers must upload:

• The expired certificate; and

Either:

• A letter from the notified body confirming receipt of the manufacturer’s application and a signed agreement; or
• A manufacturer declaration confirming:
  • A contract with a notified body was signed before the certificate expired; or
  • A derogation or grace period was granted under EU MDR Articles 59 or 97.

A template for this declaration is available via the MHRA.

Updating the MHRA DORS system

If relying on an extended CE certificate under Article 120(2), manufacturers must update their device registration in the DORS portal. The updated MHRA guidance provides step-by-step instructions for:

• Extending registration of already registered devices.
• Registering eligible devices from scratch.

For any organization marketing medical devices in Great Britain, staying aligned with both EU and MHRA timelines is vital.

These changes are more than just administrative, they determine continued market access and regulatory compliance. If you have questions about interpreting this guidance or updating your device registrations, the team at G&L Scientific is here to help.

Mike Picchioni is Associate Director of Regulatory Affairs at G&L Scientific.