The UK government published on 21 May 2024 its “statement of policy intent” (direction of travel, so not law yet) for international recognition of medical devices in Great Britain (GB). This is part of the continuing slow drip-feed of information about the future regulation of medical devices in GB (Northern Ireland being under EU law still). This is intended to follow-on from the recognition of CE-marked devices in GB which will continue until 30 June 2030 at the latest, but we can expect the international reliance route to be available ahead of that date.
What does this mean?
Companies selling their medical devices internationally and which already have authorisations in any of: Australia, Canada, the EU or the USA might be able to use that authorisation to fast-track their medical devices onto the GB market. There are different requirements for different types of authorisation and categories of device. The biggest caveat is that the recognition of the US equivalence to predicate route (510K) is limited to the lowest risk devices, which is by far the largest category of devices in the US.
Nevertheless, for many devices there will be no “authorisation” process, just a filing. For the rest there is to be an abridged assessment by the MHRA or approved bodies - to be confirmed. The outcome would be a certificate of international recognition giving access to the GB market which would expire with the original authorisation if it is time limited, or otherwise with the QMS certificate.
These devices will not be labelled with a UKCA mark and must comply with a list of conditions such as labelling and packaging in English, UK UDI, compatible with English electrical requirements (plug and voltage), units of measure and labelling, and having a UK Responsible Person who will be named on the label.
The MHRA is also considering providing exemptions via what is known as the derogation route for devices with current approvals. These would be in the “interest of public health” which is not defined.
Is every device included?
There is a long list of exclusions from international recognition:
- devices relying on the in-house exemption
- custom-made devices (query here what the definition will be in the legislation - the narrower EU definition, or the wider current UK one?)
- SaMD (including AIaMD) that do not meet the MHRA's intended purpose guidelines
- SaMD (including AIaMD) approved on an equivalence to a predicate (eg US 510k) (equivalence)
- if the authorisation being relied on is itself via a recognition route
- Class IIb non-well established technology and implantable devices approved via equivalence
- Class III devices approved via equivalence
- companion diagnostics and combination products containing medical substances not licensed in the UK (there is an error here - it should say companion diagnostics for medicines not licensed in the UK)
- products excluded from the UK MDR (eg blood products and human and animal tissue products, but presumably the list of exclusions could change in the new legislation)
What regulatory hurdles for international recognition of medical devices in GB?
Note that the classifications will be those in the GB regulations, some of which might change from those currently in the UK Medical Device Regulations 2002
A. Class I general medical devices (not sterile, measuring or reusable) and non-sterile Class A IVDs
For these devices there will be a process for recognition and self-registration with the MHRA. The manufacturer will have to self certify compliance with ISO 13485.
B. General medical devices a except devices which:
- are at A above or C or D below
- are AIaMD where the classification in original country is different vs UK
- are compliant with Australian or pre market approval (PMA) legislation in the USA
Manufacturers will need to submit a dossier in IMDRF or equivalent format to the MHRA. This will not be reviewed, but will be assessed in the event of post-market events.
The MHRA will review the PMS plan and associated PMS report or periodic safety update report.
C. Devices compliant with EU regulations except those in A above, and IAaMD and devices with a different classification in the EU vs GB
The same submission and review requirements apply as at B. Manufacturers will need to supply implant cards and patient information leaflets (PIL) for implantable devices for the UK. A summary of safety and clinical performance will be needed for Class III and implantable devices.
D. This applies to a long list of devices:
- Class Is/m/r medical devices that comply with devices legislation in Canada or DeNovo or Premarket Notification (510k) legislation in the USA
- Class IIa, IIb, III medical devices that comply with devices legislation in Canada or DeNovo legislation in the USA
- Class IIa, IIb (non-implantable) and IIb (well established technology (WET)) medical devices that comply with 510k legislation in the USA
- sterile Class A IVDs that comply with devices legislation in Australia, Canada or Premarket Approval, DeNovo or 510k legislation in the USA
- Class B, C, and D IVDs that comply with devices legislation in Australia, Canada, or Premarket Approval, DeNovo or 510k legislation in the USA
- AIaMD that comply with devices legislation in Australia, Canada, EU[2], or Premarket Approval or DeNovo legislation in the USA
- any device where the classification is different in the CRC to that under the UK Medical Devices Regulations
The same requirements apply as at B, save that the PMS plan and PMS report or PSUR must have evidence of approval. Any different classifications will be reviewed. The implant card and PIL requirements above will apply. A summary of safety and clinical performance will be need for class III and implantable devices. Clinical data may be reviewed on a sampling basis and for AIaMD there will be a review of premarket (training and test) data, implementation, verification and validation and use of predetermined change control plans.
When?
The MHRA says it is aiming for the core regulations to be in force in 2025 - although this might slip given that the UK will have elections and potentially a change of government in the next year.
What does this mean for manufacturers?
Because of the exclusion of so many devices cleared via the 510K route, recognition of US authorisations is relatively restricted. The requirement for submission of a dossier in IMDRF format for all but the lowest risk devices adds to the administrative burden, but a quicker option for recognition is to be welcomed. As noted in our article on PMS regulations, the UK will have stringent PMS requirements different from those in the EU.
What has not been said?
Critical to business are timings for authorisations: there is no commentary on this. The MHRA has also not said what will happen if the file is not accepted: can they simply ask for more information or is there a straight rejection and if so, what will be the criteria? It is also up for debate as to who will undertake the review: the MHRA (the preference of a regulator that is attempting to regulate medical devices in the same way as medicines), or UK approved bodies - which have both the necessary skill set and the ability to more quickly flex to incorporate these reviews in their workflows.
Current UKCA marked devices
The MHRA has additionally said that products with a UKCA mark under current legislation ought to be subject to transitional arrangements until the sooner of:
- for general medical devices, the certificate expiring and 3 years after the regulations take effect
- for IVDs, 5 years after the regulations take effect.
This is subject to no significant change and continued compliance with PMS requirements.
Manufacturers might like to update their certificates for these devices in order to extend the transitional period for as long as possible.
