Looking ahead in 2025 and MHRA reliance
International reliance is a mechanism whereby certain medical devices could access the UK market more quickly if they have already been approved by a comparable regulator, rather than undergoing a further full review for UK purposes only.
During late 2024, the MHRA – as part of a broader consultation on routes to market – restated its intention for the future UK regulation of medical devices to rely on the work of four other comparable regulator countries, describing it as a ‘smarter’ form of regulatory oversight. The final plan will be published along with the future regulations during 2025.
This philosophy broadly mirrors a similar approach now in place for medicines. The “International Reliance Procedure” (“IRP”) has applied since 1st January 2024, replacing existing EU reliance procedures to apply to authorisations from seven trusted international regulators.
Both these regimes could facilitate the market introduction of eligible medicinal products and devices, but it will be important carefully to review whether a device or medicine qualifies for the respective expedited review process, as there are many qualifications and nuances that could affect the status of the product.
Background
In the wake of Brexit becoming effective from 2021, the UK Government was concerned about potential delayed availability of new medicines, fearing that companies would prioritise submitting applications to larger markets such as the US and EU – or deciding to forgo the UK market altogether. For instance, in 2022 the United States accounted for 43% of the global pharmaceutical market, Europe as a whole 22%, and the United Kingdom just 2.3%.
In his March 2023 budget, the then UK Chancellor, Jeremy Hunt, accordingly announced that from 2024 the Medicines and Healthcare products Regulatory Agency (MHRA) will adopt a new regulatory model, allowing for “near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world.”
This follows the MHRA’s ambition to remain a globally recognised regulatory agency in the post-Brexit era, as enshrined in the MHRA Corporate Plan that wishes to be seen as a “globally unique concentration of expertise in data, standards, and regulation.” Its plan over the next few years is indeed ambitious.
Whether or not the policy of reliance is consistent with the United Kingdom’s ambition in making use of “Brexit freedoms”, rather than tying the MHRA’s ability to decisions made by EU and other agencies, it is arguably a pragmatic response to the increased responsibilities placed by Brexit on the MHRA as a stand-alone agency.
The beginning of 2025 has now ushered in the Windsor Framework, which will modify the original Northern Ireland Protocol, a major post-Brexit impediment for the Northern Ireland market. The new arrangements will make the supply of medicines to the UK market simpler and easier.
Overview of the proposed plans for device reliance
The MHRA is proposing an International Reliance system for device products approved by four comparable regulator countries (CRCs): Australia, Canada, the EU, and the USA. To be eligible for the proposed framework, the product will need to be in accordance with applicable CRC and UK legislation and the producer needs to have in place a UK responsible person and comply with post-market surveillance requirements. The route to obtaining a standalone UKCA mark will continue alongside.
The proposed framework would provide for a certificate of international recognition.
Certain devices considered not to have undergone full review – such as, for example, Class IIb (non-well established technology) implantable and Class III medical devices approved via a route that relies on equivalence to a predicate (e.g. US 510(k)) – would not be eligible for such international recognition.
The proposed routes to recognition are as follows:
- Low risk (Class 1 medical other sterile, measuring, and reusable Class I medical devices and non-sterile Class A IVDs) can be recognised with a declaration by the manufacturer of compliance with an appropriate quality management system, such as ISO 13485.
- With other devices (other Class I medical devices and Class A IVDs), as well as Class II and III devices (and B, C, and D IVDs) in compliance with applicable CRC, manufacturers will need to submit a dossier in the International Medical Device Regulators Forum (IMDRF). The full dossier will not be reviewed during the submission process, but may be assessed during the review of post-market events if needed. Evidence of approval and a PMS plan and associated PMS report will be reviewed. This route excludes Artificial Intelligence as a Medical Device (AIaMD) and devices where the UK and CRC classifications differ.
- For certain devices, including AIaMD and devices where the UK and CRC classifications differ, where the CRC conducted only an abridged assessment (such as a 510(k) in the US) and certain categories of devices in Australia, Canada, and the USA, certain additional checks and obligations would be required in addition to the supply of the dossier to the IMDRF. These would include implant cards and patient information leaflets for implantable devices and a summary of safety and clinical performance for Class III and implantable devices, and Class C and D IVDs. For AIaMD there would be a review of premarket (training and test) data, implementation verification and validation, and use of predetermined change control plans.
Overview of the Medicinal Product International Reliance Procedure
Since January 2024, the old European Commission Decision Reliance Procedure for centrally authorised products and the Mutual Recognition/Decentralised Reliance Procedure have been subsumed into the IRP. The IRP has enabled the MHRA to fast-track decisions on the “same product” approved by regulators in the United States, the European Union, Australia, Canada, Japan, Switzerland, and Singapore (“Reference Regulators”/“RRs”).
“Same product” is defined as products having “the same qualitative and quantitative composition (active substance(s) and excipients), and the same pharmaceutical form, from applicants belonging to the same company or group of companies or which are ‘licensees’.”
The IRP can be used for most new marketing authorisation applications, including generic, hybrid, and biosimilar applications, as well as line extensions, variations, and renewals. Traditional herbal registrations and homoeopathic registrations, as well as bibliographic applications, are not eligible.
There are two recognition routes: recognition A on a 60-day timetable (with no clock stop) and B on a 110-day timetable (with a possible clock stop at day 70):
- Recognition A is open to products where the RR approval has been granted within the previous 2 years and where manufacturing process is the same as that approved by the RR. with no clock stop. However, if major objections are identified that cannot be resolved within 60 days, the timetable may revert to Recognition B.
- Recognition B applies where the RR approval was granted within the previous 10 years (or longer, where the MHRA agrees).
In addition, there are 24 conditions which mean that a product caught by these conditions must undergo Recognition B – these include conditional or exceptional circumstances approvals or other specified risk factors. The 110-day timescale is to allow for consultation with the Commission on Human Medicines (CHM), if necessary.
The MHRA retains the authority to reject applications if it considers the evidence provided is insufficiently robust.
Finally, on the subject of ease of movement, the Northern Ireland Protocol necessitated by Brexit meant that different licensing procedures and separate licences were in place for medicines to be supplied to Northern Ireland. This has now been eased by the Windsor Framework coming into effect on 1st January 2025, whereby all medicines licensed in the UK will be authorised by the MHRA under the UK Human Medicines Regulations 2012.
This article is provided as a general informational service and it should not be construed as imparting legal advice on any specific matter.
