MHRA Statement of Policy Intent: International Recognition of Medical Devices

On 21 May 2024, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a new statement of policy intent for recognition by the UK* of international regulators’ approvals of medical devices.

Access the publication here: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices.

In 2021, the UK government’s response to the consultation on the future medical device regulations in the UK detailed the intention to proceed with introducing alternative routes to the UK market, which utilised approvals from other countries in addition to the current UKCA (UK Conformity Assessed) marking process. This statement moves this process to the next stage.

(*Note: This statement applies to Great Britain [GB – England, Wales, and Scotland only; requirements for Northern Ireland are covered under the EU requirements])

Currently, the UK recognizes CE certification from the EU. This process is limited to 30 June 2030, at the latest, to facilitate the transition following the UK’s exit from the EU. It should also be noted that the MHRA does presently recognize other international regulators’ approvals for medicines.

The use of international regulatory approvals for medical devices will ease the regulatory burden on manufacturers by reducing duplication and allowing the MHRA to concentrate its focus on high-risk and innovative products. However, medical device manufacturers will still have the option to use the UKCA marking to place devices on the Great Britain market.

The MHRA will retain the authority to reject applications using other regulatory approvals if the evidence provided is considered insufficiently robust. The comparable regulator countries (CRCs) for the proposed framework will be:

Country/Jurisdiction	Regulatory Authority
Australia	Therapeutic Goods Administration (TGA)
Canada	Health Canada
European Union (EU)	National Competent Authorities in the Member States of the EU/ European Economic Area (EEA)
United States of America (U.S.)	Food and Drug Administration (FDA)

*NAMSA’s experts have offered their perspectives on the recent proposal. Their comments are indicated in red below.

To be eligible for the proposed framework, products will need to:

• Comply with the relevant legislation in the relevant CRC.
• Have English language labelling and packaging.
• Comply with Great Britain’s requirements for electronics compatibility (frequency, voltage, and plug type), units of measurement, and labelling materials of concern where applicable (for example, for substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR), of category 1A or 1B, or could result in sensitisation or an allergic reaction).
• Have all aspects of the device in line with the device that is currently authorised in the CRC, including the design, manufacturing process, and intended purpose.
• Have a UK responsible person and their name and address of which will be included on the label (this may be via over-labelling, and MHRA will also investigate the ability for digital labelling or digital label solutions).
• Have a physical unique device identifier (UDI) on parts and labels in compliance with the UK Medical Devices Regulations or the CRC requirements.
  • There does appear to be an inconsistency in this requirement as the CRC requirements on UDI will not be the same as the UK MDR requirements (e.g., EU and US UDI requirements are different, so both cannot be compliant with the UK MDR), so the main function of UDI, the traceability of medical devices, will not function fully as it will require the user of the device (healthcare institution) to have compatible reading systems for the different UDI specifications.
• Comply with the new Post-Market Surveillance (PMS) requirements in the UK Medical Device Regulations, which are expected to come into force sometime in 2024.

The proposed framework would provide a certificate of international recognition that will grant devices access to the Great Britain market but would not provide a UKCA marking or UKCA certification.

Market access for eligible devices would be in accordance with the validity of the supplied certificate from the CRC and must be re-certified when their original certificate, if applicable, expires. Where the CRC allows indefinite market access (such as in the U.S.), the validity for the certificate of international recognition would be in accordance with the Quality Management System (QMS) (for example, MDSAP) certificate.

As MDSAP/ISO13485 is not presently mandatory in the U.S., this could mean that validity could be based on ISO 9001 certification, which would not generally be considered sufficient to define the regulatory use of medical devices. The only country where this would not be an issue is Canada, where MDSAP certification is mandatory.

The following would be excluded from international recognition:

• Exempted in-house devices.
• Custom-made devices (CMDs).
• Software as a Medical Device (SaMD) (including Artificial Intelligence as a Medical Device (AIaMD)) products that do not satisfy the MHRA Intended Purpose Guidelines.
• SaMD (including AIaMD) products are approved via a route that relies on equivalence to a predicate (US 510(k)).
• Products granted market access in the CRC via a recognition route.
• Class IIb (non-well-established technology (WET)) implantable and Class III medical devices approved via a route which relies on equivalence to a predicate (US 510(k)).
  • Given the MHRA’s pivotal role in developing the EU MDR prior to Brexit and the drive for clinical data on the device itself, it is understandable that higher-risk devices relying on equivalence for 510(k) approval are excluded. However, this does indicate that the MHRA will find equivalence for low-risk devices acceptable, which potentially conflicts with the direction of travel with the UK MDR. This may be a necessary compromise to allow U.S.-approved devices to be included in this process.
• Companion diagnostics are approved via a route that relies on equivalence to a predicate (U.S. 510(k)).
• Companion diagnostics and combination products containing medicinal substances that are not licensed in the UK.
• Products excluded from the scope of the UK MDR 2002 (listed in Regulation 3).

It is noted that most of the exclusions relate to high-risk devices, SaMD and AIaMD, which obtained approval via the use of predicate devices under the 510(k) process. One of the consequences of this exclusion policy is that devices CE-marked under the EU MDR do not appear to have many, if any, exclusions, so a more general question of the requirement and feasibility for standalone UKCA certification is raised.

This also appears to be in contradiction with the consultation process on the new UK MDR where it was indicated that the UKCA regulation will introduce new requirements on entire equivalence on a biological, technical, and clinical basis. The consultation document states, “This approach would take us beyond the equivalence requirements in the EU MDR.” Also, there will be no exemptions for clinical evidence requirements for implanted devices such as screws and wedges included in the UK regulations. This differs from the approach taken in the EU. How these additional requirements above the EU MDR requirements will be accommodated in this recognition process does not appear to have been covered in this initial proposal.

One possible scenario resulting from this proposal is that UKCA certification will only be of interest to and used by UK-based manufacturers who sell into their local market, with no international dimension to the customer base for UKCA certification.

Classifications

The classifications listed in each proposed access route refer to the classification that will apply under the UK Medical Devices Regulations, which may not be the same as the classification in the CRC.

Self-Certification/Registration

This applies to the following devices that comply with device legislation in any of the specified CRCs (Australia, Canada, EU or U.S.):

• Class I medical devices, other than Class I(s)/(m)/(r)—(I(s): sterile; I(m): measuring; and I(r): reusable).
• Class A in vitro diagnostics (IVDs) that are non-sterile.

A declaration by the manufacturer of an appropriate QMS, such as ISO 13485 or a product-specific equivalent, will be required for these devices.

Approval Process

• Manufacturers will need to submit a dossier in the International Medical Device Regulators Forum (IMDRF) ‘table of contents’ format or equivalent format used in the CRC. The full dossier will not be reviewed during the submission process but may be assessed during the review of post-market events if needed.
• Evidence of approval, a PMS plan, and an associated PMSreport or Periodic Safety Update Report (PSUR) (where available) will be reviewed.
• Manufacturers will need to supply implant cards and patient information leaflets for implantable devices in the UK. A summary of Safety and Clinical Performance (SSCP) will also be required for Class III and implantable devices and Class C & Class D IVDs.
• Clinical data may be reviewed on a sampling basis.
  • This is a very open requirement; details on who does the review, the criteria used for the review, and how the sampling process is decided will significantly impact the success of this process.
• For AIaMD, there will be a review of premarket (training and test) data, implementation verification, and validation and use of Predetermined Change Control Plans (PCCPs).

Next Steps

• This proposed framework is still a draft, and the final version would come into force simultaneously with the future core regulations, which aim to be in force in 2025.
• The operational aspects of this framework, including who the documentation is submitted to, who reviews the documentation, who performs the subsequent post-market surveillance and change assessment, and the requirements for these assessments, are being developed under discussions with industry, designated UK Approved Bodies.
  • These are significant issues and require full agreement. The decisions in this area will significantly impact the success and feasibility of this proposed process.
• Market access via this proposed international recognition process will only be formally granted once the future core regulations are in force, and the proposed framework may be updated based on these activities.
• Transitional arrangements for presently UKCA-marked devices with the future core regulations will be introduced.
• MHRA is also considering exercising, in the interests of public health, the powers in the existing UK MDR to provide exemptions for certain devices with current approvals in the specified CRCs. The decision on whether a device may be authorised under these regulations will be made in conjunction with the National Health Service (NHS) and the Department of Health and Social Care (DHSC).

Conclusions

This proposal from the MHRA is a pragmatic solution to allowing devices into the UK market via approvals in other jurisdictions. The choice of jurisdictions is limited and restricted, and there is no free-for-all approval process.

The proposal significantly reduces the regulatory burden on manufacturers, thereby ensuring continued access to devices for UK patients and ensuring that the MHRA focuses its finite resources on high-risk and novel devices where local regulation is most needed instead of unwanted duplication with no added benefit. Given the MHRA’s pivotal role in developing the EU MDR prior to Brexit and the drive for clinical data on the device itself, it is understandable that higher-risk devices relying on equivalence for 510(k) approval are excluded. The final version is expected to detail the mechanics of the process, as this policy intent does not provide details of the documentation to be submitted, the review process (and who will perform it), and the frequency of potential sampling of clinical data.

Also, as indicated in the consultation documents, inconsistencies between the recognition process and the proposed aims of the new UK MDR requirements have been resolved, allowing the recognition process to work as intended.

The primary focus of this new recognition process is correct in ensuring the UK regulatory authorities concentrate their compliance and surveillance activities on high-risk and novel devices, with more general and legacy devices being left to the international recognition process. However, the interesting question is whether this will be politically accepted in the UK, particularly if there is a safety issue with a general/legacy device, and it is highlighted that the device was approved for use on the UK market outside of the control of the UK regulator.