Future UK MHRA Regulatory Framework

The MHRA conducted a webinar on 5 March 2024, discussing the upcoming UK regulatory changes. Today the recording was published on their website, under Section 4, Future Core Regulations: HERE

Background

The updated legislation (UKCA Marking) will replace the current requirements under the UK MDR 2002, which are based on the old European Medical Devices Directive 93/42/EEC.

These reforms have been in process since 2021. Originally planned for July 1, 2023, the new, updated legislation has been postponed. Now sections of the legislation will be released via separate Statutory Instruments (SI) over the next few years. This includes Statutory Instruments on Post-Market Surveillance, the future Core Regulation, and additional requirements as needed, e.g., fees.

In the meantime, manufacturers can choose to UKCA Mark their devices under the current version of the legislation. Or, they can leverage their European CE Marking to register their devices in the UK. For devices that do not yet have UKCA or CE Marking, there may be an advantage to UKCA Marking early. See more on that in the “Further Reading” section below.

Proposed Changes

The regulatory changes detailed in the webinar are largely the same as those reported previously: here and here

As detailed previously, the amended UK legislation is expected to largely align with the EU MDR and IVDR, with some deviations. For example, the UK will have 23 classification rules for medical devices, versus 22 under the EU MDR.

Proposed changes include:

Timing

The Statutory Instrument (SI) for the Core Regulation is still in the process of being drafted.

Once complete, it will be provided to the World Health Organization (WHO) for publication. Next, laid down and debated in parliament. Then, once the final version is agreed upon, the SI will go into force in a minimum of six months from being signed into the statute book.

UK Framework for International Recognition

The above webinar did not address the status of the UK’s international recognition pathway. This is the MHRA’s new program to establish equivalency routes for “trusted” regulators, such as the US FDA . However, it was addressed separately: HERE

Per this update, the MHRA intends to publish an outline for the International Recognition Framework later this spring (subject to the necessary approvals).

In advance of that, the MHRA will be testing out the recognition framework with a few products. However, note that these devices will not be granted regulatory approval during this process. Instead, it is a way to test the practical application of the process and identify weak points.

Further, the MHRA mentioned that it would be co-chairing one of the International Recognition panels during the March 11-15 IMDRF meetings, which were hosted by the US FDA in Washington DC.

What does International Recognition mean for the future of UKCA Marking?

As far as we know today, the MHRA will recognize CE Marking through 2028-2030 (depending on the type of device). After which, presumably, UKCA Marking becomes mandatory to continue marketing in Great Britain. However, considering the recognition pathway, we must wait and see what will be required in the long-term.

Note: While companies may leverage their CE marking in the UK, this does not exempt them from other obligations. For example, appointment of a UK Responsible Person and registering devices with the MHRA.

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IMDRF March Meetings

Today the IMDRF published the meeting outcomes, available: HERE

Here you can find updates presented by:

The Reliance presentations highlight how the various IMDRF members are working to improve cooperation with one another’s regulatory frameworks, as well as documenting success cases.

For example, the Australian TGA’s abridged review scheme. It is available for qualifying devices with marketing authorizations in Canada, Japan, Europe, the USA, or Singapore. This mechanism provides faster access to technology, reduces duplication of regulatory effort, reduces costs to manufacturers, and allows the TGA to better use its resources. The TGA also notes that 1) they are in discussions with the UK MHRA for reliance and recognition, and 2) they may expand reliance scope for additional devices that have USA, Canada, or Japan marketing authorization.

The IMDRF Reliance sessions also discussed areas for improvement. For example, there are some challenges when leveraging certain Japan approvals for equivalency (“abridged”) registrations in Mexico. The Mexico registration timeframe has been shortened for high-risk devices that have Pre-Market Approval (PMA). However, there are reports that Japan Class II (third-party) Certified devices are more difficult to leverage, with increased paperwork and translation problems.

What’s Next?

We will be waiting for the MHRA to:

Further Reading

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