MHRA announces Early Access Service for Innovative Medical Devices

In another welcome development, the MHRA has published an interesting Statement of Policy Intent for Early Access Service to Innovative Medical Devices. The proposed Early Access Service will take on learnings from but exist outside of the Innovative Devices Access Pathway (IDAP) and will provide wider access for innovators. The MHRA aims to provide a pathway to get innovative medical devices to patients more quickly, so devices that use this service may be granted conditional market access.

Early Access Service - Key features

The Statement of Policy Intent suggests:

1. this will be for devices addressing an Unmet Clinical Need (UCN);
2. the MHRA (rather than an Approved Body or Notified Body) will grant a conditional Authorisation to innovative devices that do not yet fully comply with all regulatory requirements if they meet the scheme’s requirements; 
3. such Authorisation will be temporary for a limited period (and presumably for a limited patient population); and
4. the manufacturer will be obliged to monitor and report safety incidents.

The MHRA’s statement makes it clear it will be focusing on devices that meet an UCN within the NHS. It states the initial focus will be on innovative diagnostic devices, which support the NHS’s most urgent needs and financial stability. 

However, it is clear that this will be of broader application. The MHRA statement notes it will provide conditional market access to innovative devices that have the potential to “significantly improve patient outcomes.” The Scheme may be available to maintain patient access to a device that has successfully concluded its clinical investigation^[1] and is awaiting a Conformity Assessment by a Notified Body (or an Approved Body).

Pro-innovation intent

Conditional approvals such as those included in this new service were floated back in 2021 in the first consultation on changes to the UK framework for medical devices.

It also appears as though:

1. this is intended to accelerate access to innovative technologies;
2. this will be of general application and will not be limited to products that manage to win the golden ticket of accessing projects such as the Innovative Devices Access Pathway (8 products) or the recent AI Airlock (4 products).

This initiative builds on the MHRA’s positive experience of granting UCN Authorisations as part of IDAP. This Scheme will also extend the use of the UCN Authorisations tool used in IDAP.

Unusually, but pleasingly, the MHRA proposes to add additional resources to this function.  This is likely to be given a statutory basis with the proposed updates to the UK framework for medical devices, which is currently scheduled to take effect in mid-2026. 

The move is consistent with the realisation that the regulatory systems for medical devices need to be more nimble to encourage products to come to market in Europe first, see for example the Team NB press release from earlier this year on the issuance of conditional CE Marks under EU MDR.

Distinct from Exceptional Use Authorisation or “Named Patient” Basis

Although it relies on the same statutory basis and the proposed scheme has features that are similar to the MHRA’s Exceptional Use Authorisation (EUA), this will be quite distinct from an EUA. The MHRA confirms that the EUA is not intended for innovative products gaining early access. Instead the MHRA usually only grants EUAs to allow the supply of critical medical devices to the NHS. Recently, most EUAs that we have seen or been involved with have arisen as a result of:

1. inadvertent slips in the regulatory transition from EU MDD to EU MDR or Brexit-related disruptions; or
2. a realisation that an existing product had inadvertently been mis-classified. 

This is also distinct from an authorisation to supply a non-complaint device for a “named patient” for the protection of that patient’s health.

MHRA inviting submissions

The MHRA is inviting submissions from stakeholders as it finalises this proposal. This is consistent with our recent experience with the MHRA being very open to suggestions and input. As such, we would suggest that stakeholders with an interest in innovative devices make submissions.

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^[1] The European term for a clinical trial of a medical device.