MHRA Proposes International Reliance Route for Medical Devices

By Karen Hill

Background

As noted in a previous Regulatory Update, the Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on proposed changes to the medical device regulatory framework in GB. This includes the introduction of a new framework that would allow certain medical devices authorized by other countries to be placed on the GB market without needing a UKCA (U.K. Conformity Assessed) marking or certification, although manufacturers would still have the option to use the UKCA process.

Comparable regulator countries

Four countries/jurisdictions that have comparable regulatory systems to the U.K. have been identified as potential comparable regulator countries (CRCs): Australia, Canada, the EU and the USA. Four of the former Global Harmonization Task Force (GHTF) founding members. However, it should be noted that the MHRA continues to review the list of CRCs and is in active discussions with the Pharmaceuticals and Medical Devices Agency to explore the reliance on medical device approvals from Japan.

Eligibility criteria

To be eligible for any of the access routes, the medical device must meet the following criteria:

Fall within the scope of the U.K. Medical Devices Regulations
Be classified in accordance with U.K. Medical Devices Regulations
Have English language labeling and packaging
Be supplied with an implant card and leaflet in compliance with the new U.K. Medical Devices Regulations, where applicable
Comply with GB requirements for all other relevant product requirements (e.g., machinery, electronics compatibility, units of measurement, etc.)
Have a U.K. Responsible Person (UKRP) ^[1], the name and address of which would be included on the product labeling or the outer packaging, or the instructions for use, and may be applied via over-labeling
Have a physical unique device identifier (UDI) on parts and labels in compliance with the new U.K. Medical Devices Regulations or the CRC
Comply with the new post-market surveillance (PMS) requirements in the U.K. Medical Devices Regulations 2002, which are expected to come into force in 2025
Register with the MHRA

Proposed access routes

The proposed review process is streamlined in comparison to the UKCA conformity assessment process, although some routes will require a review by an Approved Body. The four proposed access routes are summarised below:

Route

Eligible Devices

Approved Body Review

Route 1

Low-risk devices that comply with device legislation in Australia, Canada, the EU and the USA:

Class I medical devices, other than Class I sterile/Class I measuring devices
Class A IVD devices which are non-sterile

No approved body review is required.

A self-declaration for an appropriate Quality Management System (QMS) must be provided to the MHRA during registration

Route 2

Non-active devices from the EU (using MDR or IVDR):

Class Is/m, IIa, IIb, III MDs
Sterile Class A IVD devices
Class B, C, D IVD devices

The approved body must:

Confirm CRC marketing authorization
Confirm the device’s GB classification
Confirm GB requirements
Review PMS plan
Review PMS data from the last five years, where available

Route 3

Non-active devices that comply with device legislation in Australia, Canada (using Class III or Class IV license) and the USA (using De Novo, PMA of 510(k)) *:

Class Is/m, IIa, IIb, III** MDs
Sterile Class A IVD devices
Class B and C IVD devices

*Excluding devices listed in Route 4

**For devices from Canada, only devices with a Class IV license in Canada would be able to enter this route as a Class III device in GB

The approved body must:

Perform (a) – (e) in route 2
Confirm that the implant card and patient leaflet, if applicable, meet the (updated) U.K. MDR requirements
Confirm that the IFU provided with reusable devices, if applicable, contains information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging, and where appropriate, the method of sterilization, and any restrictions on the number of reuses

Route 4

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 license*) or the USA
Class D IVD devices that comply with device legislation in Australia, Canada and the USA
Active devices that comply with devices legislation in Australia, Canada (using Class III or Class IV license*), EU (using MDR or IVDR), and the USA (using De Novo, PMA or 510(k))

*For devices from Canada, only devices with a Class IV license in Canada would be able to enter this route as a Class III device in GB

The approved body must:

Perform (a) – (c) in Route 3
Confirm that the rationale for equivalence to a “reference device” for 510(k) devices meets the (new) U.K. MDR requirements
Obtain an opinion on the quality and safety of any ancillary medicinal substance incorporated into the device from the Secretary of State
Confirm Class D IVD devices meet batch test release requirements
Confirm active devices are compatible with electrical requirements in GB
For software as a medical device, review information that demonstrates there is no difference between the CRC and GB that adversely impacts the safety or efficacy of the device and the appropriateness of any pre-determined change control plans.

NOTE 1: The following devices would not be eligible for any of the above access routes:

Software as a medical device that has gained access to the USA market via the 510(k)-clearance process
Devices that comply with 510(k) legislation in the USA that are classified in GB as Class IIb implantable (excluding the devices listed in Route 4) and Class III
Devices granted market access in CRC via reliance routes
Devices that contain non-viable cells and tissues of human origin

NOTE 2: The following medical devices would only be eligible for Route 2:

Medical devices that utilize animal tissues and their derivatives
Medicinal products that include a medical device in the secondary packaging of the medicinal product (i.e. co-packaged)
Companion diagnostics

The proposed framework would provide a certificate of international reliance that can then be used to register with the MHRA and gain access to the GB market.

The manufacturer must keep the information provided during the review process for the longer of the device’s lifetime, 15 years for implantable devices, or 10 years for any other device. If a significant change is made to the device, the manufacturer must submit a new application for international reliance unless the device is software as a medical device and has a predetermined change control plan.

Public consultation

The online public consultation, which is now open and closes on Sunday, Jan. 5, 2025, includes six questions regarding the above proposed international reliance routes.

Concluding remarks

These latest enhancements to future U.K. legislation are good news for medical device manufacturers. They will have increased options available for accessing the GB market and a reduced regulatory burden. This also further advances the work of the International Medical Device Regulators Forum (IMDRF) and regulatory reliance.

If you would like your opinions to be considered, submit your responses before the January deadline.

Emergo by UL continues to monitor developments in the U.K., as they are relevant to us as a UKRP and globally. We remain optimistic that regulatory reliance is a viable solution to improving global regulatory systems.

[1] Emergo by UL can fulfil this role.

Learn more about medical device regulations in Great Britain: