MHRA Consults on New UK Pre-Market Medical Device Measures

Last month we provided an update on the UK Government's draft post-market surveillance statutory instrument ("PMS SI") and the UK Medicines and Healthcare products Regulatory Agency's ("MHRA's") intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument ("Pre-Market SI").

On 14 November 2024, the MHRA launched a consultation on proposed pre-market regulatory changes for medical devices and in vitro diagnostic ("IVD") devices (the "Consultation"). The MHRA intends to incorporate the feedback from the Consultation in drafting the Pre-Market SI.

The Consultation, which is open until 5 January 2025, addresses four areas of the future regulatory framework for medical devices in Great Britain ("GB"):

1. International Reliance Scheme
2. UK Conformity Assessment ("UKCA") Marking
3. In Vitro Diagnostic Devices
4. Assimilated EU Law

It builds on the MHRA's previous consultation in November 2021 (see our update here) and the responses to that consultation.

In the Ministerial Foreword to the Consultation, the Government makes clear that its reforms to the regulatory framework for medical devices in GB are focused on improving "timely access to high-quality healthcare". However, the Government recognises that this aim must be balanced with ensuring confidence in the safety and effectiveness of "groundbreaking medical devices".

We discuss the four areas of the Consultation below.

1. International Reliance Scheme

In May 2024, the MHRA (under the oversight of the prior Government) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the "Statement") (see our update here). The Statement proposed four expedited routes to the GB market for devices approved in comparable regulator countries, Australia, Canada, the EU and the USA ("CRCs").

In the Consultation, the new Government has proposed a number of changes to the position of the prior Government. Importantly, the name of the scheme has changed from "international recognition" to "international reliance" to align with the definitions from the World Health Organization. While "recognition" is the simple acceptance of the regulatory decision of another regulator or trusted institution; "reliance" refers to the regulatory authority in one jurisdiction taking into account and giving significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own decision. This is not just a rebranding, but rather reflects the Government's departure from the Statement, which did not require the review of the manufacturer's dossier, to the current proposal in the Consultation, which, for three of the proposed routes to market, requires involvement from UK Approved Bodies, including requirements to confirm CRC status and review certain data.

In the Consultation, the MHRA initially proposes international recognition for EU CE marked devices until 2028 or 2030, depending on their classification. However, it will then move to an EU reliance scheme, and a reliance scheme will apply also to approvals from all other CRCs (noting that the MHRA is actively exploring whether to include Japan in the list of CRCs).

To be eligible for any of the routes, a medical device must comply with many of the same requirements as proposed under the Statement (e.g., English language labelling and packaging, and compliance with the new PMS SI requirements). However, the MHRA now also proposes that to be eligible for any of the routes a medical device must fall within the scope of the UK Medical Devices Regulations 2002 ("UK MDRs") and be classified in accordance with the UK MDRs. Eligibility for a specific route depends on the device's classification under the UK MDRs and which CRC device legislation the device complies with.

The Consultation seeks input on the elements of the MHRA's proposed international reliance scheme and whether the four proposed routes should be introduced. The four routes can be summarised as follows:

Route 1 - Applies to low-risk devices (e.g., Class I medical devices and Class A IVD devices) that comply with device legislation in any of the CRCs. No Approved Body review is required.

Route 2 - Applies to non-active devices that comply with Regulation (EU) 2017/745 (EU MDR) or Regulation 2017/746 (EU IVDR). In the Consultation, Route 2 now requires review by an Approved Body, which was not contemplated under the Statement.

Route 3 - Applies to non-active devices that comply with device legislation in Australia, Canada and the USA. Route 3 also now requires review by an Approved Body.

Route 4 - Applies to:

• Class IIa, IIb (non-implantable) and IIb non-resorbable sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors that comply with 510(k) legislation in the USA;

• Medical devices that incorporate an ancillary medicinal substance from Australia, Canada (using Class III or Class IV licence) or the USA;

• Class D IVD devices that comply with devices legislation in Australia, Canada and the USA; and

• Active devices that comply with devices legislation in Australia, Canada (using Class III or Class IV licences), EU, and the USA (using the De Novo, pre-market approval or 510(k) process).

In line with the new eligibility requirement that a medical device must be classified in accordance with the UK MDR, the "catch-all" category in the Statement, "any device where the classification is different in the CRC to that under the [UK MDR]", has been removed in the Consultation. Route 4 also now requires review by an Approved Body.

The scheme currently excludes certain devices, such as medical device software and Class III medical devices which have gained access to the US market via the FDA's 510(k) regulatory pathway (i.e., the device was approved on the basis of it being "substantially equivalent" to a reference device already on the US market). The Consultation asks whether such devices should be eligible if the FDA's finding of equivalence meets the requirements of the UK MDRs for entire equivalence on a biological, technical and clinical basis.

Further, in the Consultation, the specific requirements for Artificial Intelligence as a Medical Device ("AIaMD") proposed in the Statement have been removed. The Government cites AIaMD specific safety challenges, including performance degradation and unwanted bias, as the reason for this change. The Government proposes "that all software as a medical device would initially only be eligible for Route 4 in the proposed framework."

2. UKCA marking

The Consultation seeks views on removing the requirement for physical UKCA marking for medical devices that have been through the UK conformity assessment process, on the basis that this requirement potentially creates a barrier to market for manufacturers. Instead of requiring the device and its labelling (e.g., packaging and instructions for use) to bear a UKCA mark, manufacturers would be required to assign Unique Device Identification ("UDI") to devices before they are placed on the GB market and to register such UDI with the MHRA. If implemented, this change would remove the need for manufacturers to maintain a separate line of UKCA-marked products only for the GB market. However, the MHRA confirms that this would not impact the conformity assessment process. In addition, any other applicable marking requirements from other product safety or health and safety legislation, such as electrical equipment safety and restriction of the use of certain hazardous substances in electrical and electronic equipment, would still apply.

3. In Vitro Diagnostic Devices

The MHRA will introduce a new classification system for IVD devices based on the risk to patient and public health posed by the IVD device. This system will align more closely with structure used by the International Medical Device Regulators Forum ("IMDRF") and the EU IVDR, but with some exceptions to better reflect public health risks in the UK. The new classification system consists of four classes, with Class A being the lowest risk and Class D being the highest risk. Compared with the EU, the UK is proposing higher classification of life-threatening diseases and the addition of cardiovascular and neurodegenerative diseases in Class C.

To gain access to the GB market, the manufacturer of an IVD device must complete a conformity assessment procedure. The Consultation seeks views on a risk-based approach to the specific conformity assessment requirements for each IVD device classification, with the level of regulatory scrutiny increasing with the level of risk:

• Class A IVD devices - requiring a UKCA self-declaration of conformity.

• Class B IVD devices - requiring a UKCA self-declaration of conformity and Quality Management System ("QMS") certification issued by a certification body accredited by the United Kingdom Accreditation Service ("UKAS"). This proposal departs from the assessment requirements for Class B IVD devices in the EU, which must be conformity assessed by a Notified Body.

• Class C IVD devices - requiring a UKCA conformity assessment by an Approved Body.

• Class D IVD devices - requiring a UKCA conformity assessment by an Approved Body, batch release testing, and compliance with common specification requirements (which will be based on the outcome of the consultation conducted by the MHRA in May 2024, the feedback from which is currently under review).

The essential requirements for the conformity assessment of IVD devices will be updated to align with the general safety and performance requirements under the IVDR. The above conformity assessment requirements will also apply to IVD software.

The MHRA has queried whether, if the above approach is implemented, Class A and B IVD devices should be removed from the scope of international reliance. In that case, the CE mark for Class A and B IVDs would likely no longer be accepted as a route to the GB market.

4. Assimilated EU law

Finally, the Consultation asks if the public agrees with the MHRA's proposal to remove the current 26 May 2025 revocation date for four key pieces of EU legislation within the GB regulatory framework:

• Commission Decision 2002/364 - sets out common specification requirements for certain IVD devices.

• Commission Regulation (EU) No 207/2012 - establishes the conditions under which the instructions for use of medical devices may be provided in electronic form.

• Regulation (EU) No 722/2012 - sets out requirements for medical devices manufactured using animal tissue.

• Regulation (EU) No 920/2013 - sets out requirements on the designation and supervision of approved bodies.

The MHRA proposes to retain this legislation to prevent "significant disruption to the regulatory framework and, consequently, negative impacts on patient safety."

Next Steps

Anyone wishing to respond to the Consultation should do so before 5 January 2025 using the survey found here. The survey has 12 questions, across the four topics outlined above.

If you would like to discuss the MHRA's Consultation and what the proposed changes to the regulatory framework for medical devices in the UK may mean for your company's operations, please contact our specialist UK and EU medical device regulatory team.

Covington will continue to follow developments and provide further updates, including on future planned MHRA consultations in areas such as the expansion of digital labelling and the scope of the health institution exemption.

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