On 21 May 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent (the Statement) setting out its proposals for international recognition of regulatory "approvals" of medical devices. Under the proposed scheme, medical devices will be subject to limited pre-market requirements where they are already "approved" in a trusted jurisdiction. This will replace the current provisions, which permit recognition of EU CE marks, and will expand recognition to a wider set of trusted regulators, including the US in certain cases. This has long been an intention of the MHRA, and follows a similar procedure for medicines announced last year, although the practicalities of how this will work for devices and the role of the relevant stakeholders has been difficult to resolve.
The proposals are intended to avoid duplication of assessments for medical devices and it is hoped this will lead to quicker access to new devices in Great Britain. It will also allow the MHRA to meet its stated aim of focusing resources on innovative devices, particularly artificial intelligence medical devices (AIMD) that are excluded from the scheme. However, the Statement is silent on who will undertake the reviews required under the access routes. This is subject to ongoing consultation, though it seems likely that any reviews would be conducted by UK Approved Bodies. This will require coordination between Approved Bodies and the MHRA, which will be an important step in ensuring this scheme operates as intended.
The MHRA intends that the new recognition scheme will come into force at the same time as the future core changes to the medical devices regulatory framework in Great Britain, discussed in a previous post. It is expected the draft regulations implementing that scheme will be published later this year, with the regulations coming into force in 2025.
From which jurisdictions will approvals be recognised?
The countries/regions from which the MHRA will recognise the approvals and certificates are the following "comparable regulator countries" or CRCs:
- Australia
- Canada
- EEA countries
- USA
How will recognition work?
The Statement sets out four access routes for recognition, taking account of the risk classification of the device, the format of the authorisation procedure in the CRC and other risk-based factors.
For all but the lowest risk class devices (i.e. those within the scope of (1) below), the manufacturer will need to submit a dossier in a specified format. The dossier will not be subject to full review pre-market, but may be reviewed in response to post-market events. For devices covered by procedures (2) and (3) below, the manufacturer will also need to submit evidence of approval and a post-market surveillance (PMS) plan along with certain other PMS documents. Those documents will be reviewed at the pre-market stage.
Recognition through one of these access routes will result in a "certificate of recognition", which will be valid for as long as any certificate in the CRC upon which recognition is based or, where the approval is indefinite in the relevant CRC, the applicable QMS certificate.
Devices must comply with eligibility criteria including that all aspects of the device (e.g. its design and intended purpose) must be the same as in the CRC and that the labelling must be in English. The manufacturer will also need to comply with the soon to be updated Great Britain PMS requirements and will need to appoint a UK Responsible Person.
What are the access routes?
The four access routes are:
- Recognition, self-registration with MHRA: This applies to the lowest risk devices that would not otherwise require the involvement of a UK Approved Body. The device must comply with the applicable legislation in the CRC and the manufacturer must declare compliance with an appropriate quality management system such as ISO 13485.
- Reliance: This route applies to all other devices CE marked under the EU MDR or IVDR except for AIMD and devices that have a different classification under MDR or IVDR compared to the classification in Great Britain. The Statement does not stipulate what "evidence of approval" is required, but we expect this will include the Notified Body certificate and the signed declaration of conformity.
- Reliance with device-specific requirements: This applies for general medical devices, other than those in (1) above, which comply with Australian devices legislation or have been subject to pre-market approval in the USA, other than AIMD and devices for which the classification is different in the CRC to that in Great Britain. Manufacturers of implantable and/or Class III devices will need to submit certain additional documents.
- Reliance with abridged assessment and device-specific requirement: This is intended for a range of products deemed higher risk. These are mostly products that have not been subject to a full pre-market approval in the relevant (non-EEA) CRC, as well as all sterile and higher risk classification IVDs approved in non-EEA CRCs. It also applies to AIMD (other than those excluded from recognition – see below) and devices with a different risk classification in the CRC to that in Great Britain. Devices under this access route are subject to a broader review, including: to assess the appropriate risk classification of the device and that clinical data may be reviewed on a sampling basis. The review for AIMD will be more stringent and will include review of premarket (training and test) data, implementation verification and validation and use of predetermined change control plans.
Which categories of devices are excluded?
The MHRA's Statement sets out categories of devices that will be excluded from recognition under the new scheme. Since the UK indicated its intention to expand recognition to US FDA-authorised devices, questions have been asked about how MHRA will treat devices approved through the 510(k) clearance route. Such devices are cleared for marketing after demonstrating equivalence with a predicate, rather than undergoing a full assessment. The Statement confirms that devices with a 510(k) clearance will be accepted except when the product is one (or more) of the following:
- Certain higher risk devices, namely Class IIb (non-well established technology (WET)) implantable and Class III devices
- Software as a Medical Device (SaMD)
- Companion diagnostics
These three categories of devices can in principle rely on recognition, but only where the original approval in the CRC was based on pre-market approval and provided the device does not fall into one of the other excluded categories. These include:
- Custom-made devices
- SaMD, including AIMD, that does not satisfy the MHRA's guidance on crafting an intended purpose for SaMD (available here)
- Companion diagnostics relating to, and combination products containing, medicinal substances that are not licensed in the UK
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