UK MDR consultation – proposals for International Reliance on medical device approvals

The consultation on the future of the UK’s Medical Devices Regulations 2002 (UK MDR), initiated by the MHRA on 14 November 2024, addresses four key topics which we summarised in our overview article on this subject. It is clear from the consultation that one topic in particular takes centre stage: the MHRA’s proposals for International Reliance (IR) on medical device approvals granted by trusted regulators.

Greater recognition of foreign approvals for medical products has been a topic of UK regulatory reform since the 2023 spring budget, when former Chancellor Hunt indicated that the MHRA would implement “rapid, often near automatic sign-off” for medicines and technologies approved by trusted regulators. The objective was for the UK to have the “quickest, simplest, regulatory approval in the world.”

As we wrote previously, the MHRA first published a draft of an IR policy for medical devices back in July 2024.

This consultation gives a concrete indication of how the MHRA plans to proceed. In short, approvals issued by certain comparable regulator countries (CRCs) will provide a basis for an abridged approval process in Great Britain. Devices which are approved through IR can avoid a full conformity assessment in accordance with UK MDR before they can be placed on the market in Great Britain.

The most controversial clarification is that when a “top up” abridged review is needed, it will be conducted by a UK approved body and not the MHRA. In light of the limited capacity at UK approved bodies, this will disappoint stakeholders hoping for a genuinely nimbler system.

The IR procedure will not result in UKCA certification. Instead, the device will be issued with a Certificate of International Reliance, entitling the manufacturer to register the device with the MHRA and to place the device on the market in Great Britain for as long as the original CRC approval remains valid¹. Naturally, the MHRA can suspend or withdraw the Certificate if it believes the requirements for market access are no longer met, e.g. because it believes the device poses a risk to safety or health.

If the device undergoes a significant change, a new application for IR will need to be submitted, unless the device is software that has a predetermined change control plan.

Medical device and IVD approvals issued in the following CRCs will be eligible:

• the European Union (namely, CE Certificates issued by Notified Bodies in accordance with EU MDR and IVDR);
• the United States (namely, PMA, De Novo and 510(k) approvals issued by the FDA);
• Australia (namely, approvals issued by the TGA); and
• Canada (namely, approvals issued by Health Canada).

The MHRA is actively exploring the possibility of adding Japan as a CRC, but Japan is not included in this consultation.

Routes to market under International Reliance

Depending on the type of device and the type of CRC approval on which the application for IR is based, devices will be eligible for one of four IR routes. Each route involves a different level of scrutiny.

International Reliance route eligibility

The eligibility criteria for the different IR routes are complex. Certain categories of device are understandably excluded entirely, such as devices that contain cells and tissues of human origin, and devices which were approved in the CRC under another international reliance scheme.

Other categories of device are excluded if the MHRA considers that they were insufficiently scrutinised when approved in the CRC. For instance:

• all SaMD approved in the US on the basis of a 510(k) are excluded;
• all Class IIb implantables (subject to exceptions for certain Well-Established Technologies) and Class III devices approved in the US on the basis of a 510(k) approval are excluded;
• all Class III devices authorised in Canada will be excluded unless they have a Class IV license in Canada; and
• any device which utilises animal tissues and their derivates, which is co-packaged with medicinal products, or which is a companion diagnostic (CDx), is only eligible if the CRC approval is an EU CE certification. Such devices are excluded where the CRC is Australia, Canada or the US.

The following flowcharts represent the eligibility criteria set out in the consultation in a more digestible format:

EU approvals

US PMA and De Novo approvals

US 510(k) approvals

Australian approvals

Canadian approvals

There are some problems with the interpretation of these eligibility criteria. For instance, the criteria appear to include certain IVDs in the class of “active” devices which are subject to IR under route 4. This is not easy to interpret as there is currently no concept in either the UK MDR or the IVDR of an “active” IVD. It appears clear that the MHRA intends to capture IVD SaMDs, but it is not clear whether any other IVDs are intended to be captured as well.

Takeaways

There are a few broad points which can be drawn from the plans for IR.

First, low risk devices will have a very easy route to market via Route 1, requiring nothing more than registration with the MHRA and a self-declaration regarding the adequacy of the QMS. However, this is hardly different from the position for such products under UK MDR anyway, which allows low risk devices to be placed on the market in Great Britain on the basis of a self-certification by the manufacturer. It is questionable how much time and effort will really be saved for such devices by pursuing IR instead of a conformity assessment under UK MDR.

Second, the MHRA has a hierarchy of trust when it comes to CRC approvals, with EU approvals being the most trusted and US 510(k) approvals being the least trusted. A wide variety of device categories will be excluded entirely if the CRC approval is a 510(k). On top of that, almost all eligible 510(k) approvals will be subject to Route 4, where the manufacturer will need to satisfy a UK approved body that the device is “equivalent” to the predicate device referenced in the CRC approval in accordance with the standards set out in UK law. Essentially, the MHRA is not satisfied that a predicate device, which would be considered “equivalent” by the FDA, will necessarily be equivalent for the MHRA’s purposes. This could present a significant challenge when pursuing IR on the basis of a 510(k) approval, which might deter manufacturers if the rewards offered by access to the Great Britain market are insufficient. For devices with 510(k) approval, IR will not deliver the “rapid, often near automatic sign-off” promised in 2023.

Third, the MHRA’s hierarchy of trust means that we are most likely to see applications for IR based on EU CE certifications and FDA PMA and De Novo approvals. Despite IR based on a Canadian or Australian approval being almost as easy to obtain, most manufacturers will have an eligible EU or US approval first.

Finally, IR represents a genuinely exciting opportunity for the MHRA to expedite access to the Great Britain market for devices which have undergone authorisation elsewhere. In theory, reviewing a PMS plan, some historic PMS data, and double-checking risk classification (the bulk of the work in Route 2 or Route 3) should be a much quicker, cheaper job for a UK approved body than conducting a full conformity assessment under UK MDR. However, the MHRA needs to ensure that the scope of an IR review is carefully circumscribed and that the role of UK approved bodies is clearly delimited. The risk is that a UK approved body, being unfamiliar with this new process and wary about potential liability, might go to disproportionate lengths to satisfy itself that the device it is reviewing is sufficiently safe and performant. If UK approved bodies duplicate the review conducted in the CRC, then IR achieves nothing; the manufacturer might as well seek a full UK MDR conformity assessment. Similarly, if UK approved bodies are so risk-averse that they refuse to accept IR applications based on certain CRC approvals with which they are not familiar (e.g. CE certifications from less established EU Notified Bodies), then the objective of “rapid, often near automatic sign-off” will be frustrated across the board.

The success of IR will depend on the MHRA and the UK approved bodies learning to trust the work conducted by their counterparts in the CRCs. As the price of ensuring that post-Brexit Britain remains at the front of the queue for new medical technology, accepting a degree of risk will be required.

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^1. Strictly speaking, for devices approved based on reliance on US or Canadian approvals, validity of the certificate of International Reliance will be tied to the validity of the manufacturer’s quality management system certification (either MDSAP or ISO 13485)

^2. This refers to compliance with other product safety legislation which is applicable in Great Britain, such as machinery, electromagnetic compatibility, REACH, Restriction of Hazardous Substances (RoHS), Low Voltage Directive etc.

^3. These new requirements for equivalence are set out in Annex C in the consultation paper.