The MHRA has been extremely active, and has provided updates via its Regulatory Blog: HERE

Future Regulations

In response to the problem-filled MDR/IVDR implementation, the MHRA confirmed they will take a step-wise approach (“bite-size chunks”) to amending its regulations. And will not implement all elements in one overarching legislative change.

As already reported, the Post-Market Surveillance (PMS) legislation was laid in Parliament on 21 October 2024. And it will go into effect six months after debates/being approved.

Regarding further regulatory changes, e.g., to implement a UDI system, the MHRA hopes to:

Final timing for the legislation to be laid in Parliament, and becoming law, depends on the following variables: response from WTO members on the draft, final drafting and legal checks, Parliamentary timetables, and how the Parliamentary debates go.  

The legislative changes will be implemented as Statutory Instruments (SI), allowing for easier and faster implementation.

Further, in the coming weeks, the MHRA will set up a Guidance Working Group, to help provide guidance for all of the regulatory changes.

The MHRA hopes to publish a revised roadmap by the end of this year.

International Framework

The MHRA published its policy intent (with tentative parameters) in May 2024.

The MHRA is progressing on offering abridged approvals for certain medical devices with marketing authorization in the US, Canada, Australia, and Europe. And, hopes to shortly launch the public consultation.

Transitional Provisions

The MHRA confirmed there will be no “cliff edge” when the amended regulations go into effect. There is no intent to change the current transitional provisions for CE Marked devices and devices UKCA marked under the current version of the UK MDR 2002.

As noted in Casus’ UKCA Marking overview, these are:

They further advised the intent to allow devices undergoing conformity assessment against the existing UK MDR 2002 at the time the new regulations come into force, a further 12 months for the assessment to be completed.

IVD Devices

The MHRA intends to “consult on a more pragmatic approach to IVD legislation”. This is due to the “lessons learned from the EU IVDR”.

To this end, the MHRA has begun pre-consultation meetings this week, and will publish a consultation in mid-November.

They also intend to publish a revised IVD Roadmap in the Spring of 2025.

And will publish the results from the June IVD common specifications and CTDA public consultation, in early 2025.

Software Roadmap & AI Airlock Pilot

The MHRA is continuing to develop its software roadmap, and intends to publish draft guidance on Digital Mental Health Technologies, and AI Development and Deployment by the end of March 2025.

The blog also provided an update on the AI Airlock Pilot Program. They received nearly 40 applications and are now reviewing to identify six (6) participants for the pilot.

Innovative Device Market Access

The MHRA’s “vision is for innovators to choose the UK first” and wants for “the UK to be the first choice for…market access.”

To this end, they are continuing to learn what innovators from useful, from the Innovative Devices Access Pathway (IDAP) pilot program. And, will further look at policy development around early access for innovative products.