The MHRA confirmed that they would recognize the EU’s extension of the MDR transition period for legacy devices in Great Britain. However, they put an additional step in place.

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UK Requirement for MDD/AIMDD Legacy Devices

Class I sterile/measuring, IIa, IIb, III, & Active Implantable Devices

Per Section 3 of the guidance document linked in the MHRA webpage, Register medical devices to place on the market, an ‘EU MDR Article 120 Extension Confirmation’ template must be uploaded into the UK registration portal.

“If you wish to rely on a certificate that was valid on 26 May 2021 and has expired on or after 20 March 2023 or will expire after 20 March 2023, MHRA asks that you upload a letter declaring that the certificate remains valid under EU MDR Article 120.

We have provided a template for this letter – the above declaration is set out as option c in the letter.”

Class I self-certified devices, upclassed under the MDR

Per Section 5 of the MHRA guidance linked above, no further action is necessary to maintain your UK registration. Other than, of course, maintaining compliance with the MDR extension requirements as outlined in Regulation 2023/607.

“Until the dates set out in the table below [refer to guidance document for table], no further action is required in the registration system at this time to maintain reliance on your self-declaration under EU MDD for a device which is Class I medical device under EU MDD that is upclassified under EU MDR or is a device which is a Class I reusable surgical instrument under EU MDD that, under EU MDR, will require Notified Body involvement in its assessment.”

What about Expired IVDD CE Certificates?

In theory, this same type of requirement should be in place for IVDD CE Certificates extended under the EU IVDR Article 110 transitional provisions. However, to date, no such equivalent guidance or confirmation template appears to be available on the MHRA’s website.

This could be due to the multiple extensions to the IVDR compliance dates, and that the first IVD legacy device transition deadline does not occur until May 26, 2025. This is the date by which all IVDD legacy device manufacturers should have implemented an IVDR compliant quality system. And manufacturers of 1) IVDD Notified Body CE Certified devices and 2) IVDD self-certified devices which were upclassed to Class D, should have lodged an application with a Notified Body for IVDR CE certification.

How to Verify Your UK Registration Status

Go to the MHRA’s public registration database (https://pard.mhra.gov.uk/) and type your company’s name into the search bar. It will populate your active registrations, including status. No further action is required if the status is listed as “Registered”. However, if the status is listed as “Conformity Assessment Certificate Expired”, additional steps must be taken to update the registration.

Steps to Update Your Registration (if needed)

The exact steps are outlined in the guidance document titled: Registration of medical devices with an expired/expiring certificate that is valid under the EU MDR Medical Devices Regulations (EU MDR)

Most devices will follow the steps outlined in Scenario 3, on page 6 of the guidance.

The high-level process is:

• Complete the MHRA’s EU MDR Article 120 Extension Confirmation letter
• Log into your MHRA registration portal
• Go to Manage Registered Devices
• Unlink the expired CE certificate
• Upload the EU MDR Article 120 Extension Confirmation letter
• Update the conformity assessment validity date
• Submit the Declaration

Further Reading

• UK Responsible Person
• UK MHRA Registration Requirements
• UKCA Marking Fact Sheet
• MHRA Proposes New Fee Increase Starting in 2025
• MDR Transition Extension Guide