Shaping the future of medical devices: MHRA proposes four key changes to regulations

Background

The MHRA has launched a Consultation on future changes to the UK Medical Devices Regulations. The consultation addresses four topics:

1. International Reliance;
2. In vitro diagnostic medical devices (IVDs);
3. UKCA marking; and
4. Assimilated EU law.

This focused consultation follows on from the previous Government’s consultation in 2021 (2021 Consultation) on the post-Brexit changes to the UK Medical Devices Regulations 2002 (UK MDR).

The proposed changes will only apply to devices made available in Great Britain (GB). Medical devices made available in Northern Ireland remain subject to EU medical device regulations under the Windsor Framework. However, it is evident that the MHRA will keep an eye on the interaction between the regulatory position in Great Britain and Northern Ireland.

1. International Reliance

Currently, in order to be placed on the GB market, medical devices must bear a valid UKCA mark or the EU CE mark. In practice, very few manufacturers have obtained UKCA marks as they can continue to commercialise devices in GB on the basis of CE marks through until 30 June 2028 or 30 June 2030.  We previously explained these revised arrangements in this note.  

The MHRA proposes a new ‘International Reliance’ scheme as an alternative to the UKCA process. The scheme will allow certain medical devices that have been approved in comparable regulator countries (CRCs) to be placed on the GB market without UKCA certification or marking (subject to certain conditions and requirements). The intent is that this will facilitate quicker and simpler access by reducing duplication of regulatory assessments.

The MHRA has identified four CRCs: Australia, Canada, the EU and the USA. It is also actively exploring the possibility of reliance on Japanese medical device approvals. 

The International Reliance scheme consists of four access routes (imaginatively numbered 1 to 4) which will have streamlined review processes. The level of additional review applied to the CRC approval increases progressively in each access route, with Route 1 being the least onerous (only requiring self-declaration) and Route 4 being the most onerous (involving relatively detailed additional review, including confirmation that the device meets certain device-specific UK requirements).

Devices will be eligible for different access routes depending on the risk classification of the device under UK MDR, the nature of the device itself and the nature of the approval in the CRC. Some devices will be excluded from approval under International Reliance entirely, including most “high risk” and software devices approved under a 510(k) in the USA.

Notably, in Routes 2-4 (which involve some level of additional review), the MHRA proposes that UK approved bodies will conduct these reviews. This means that UK approved bodies will be doing most of the heavy lifting under the International Reliance scheme. The MHRA will have little significant role.

Products approved under the proposed framework will receive a certificate of International Reliance (but not a UKCA certificate or bear UKCA marking), which manufacturers will use to register their products with the MHRA. Naturally, the MHRA remains responsible for the safety and performance of all devices on the GB market, regardless of the route of approval. As such the MHRA will have the authority to suspend or cancel a certificate of International Reliance.

See Jamie Hatzel’s article for an in depth break down of the International Reliance procedure.

2. In vitro diagnostic medical devices (IVDs)

Currently, IVDs are classified using a disease-based classification system. This is out of kilter with international standards and specifically the approach adopted in the EU In Vitro Diagnostic Medical Device Regulation¹ (EU IVDR).

The MHRA proposes to harmonise and classify IVDs into four risk classes (A, B, C, and D) based on patient and public health risk. Each risk class will have a different Conformity Assessment procedure.

Proposed IVD routes to market for each class

*If a Class A or B IVD device is required to be sterile then it will need to undergo a Conformity Assessment by an approved body only for sterility.

As in the EU, the majority of IVDs will be reclassified into a higher risk class (B, C or D). Further, the MHRA proposes that the essential requirements for IVDs will be aligned with the general safety and product requirements set out in the EU IVDR.

However, there is one notable point of deviation from the EU. Under the IVDR, all devices in risk Class B and above must undergo conformity assessment by a Notified Body. By contrast, the MHRA proposes that Class B IVDs will not require conformity assessment by a UK approved body. Rather, the manufacturer can self-declare compliance with the essential requirements. In effect, in the UK, there will be no difference between the conformity assessment process for Class A and Class B IVDs, other than the requirement for Class B devices to have an ISO 13485 Quality Management System certification, which is not mandatory for Class A devices. However, most manufacturers operate under an ISO 13485 certification regardless of the risk classification of the devices which they manufacture.

3. UKCA marking - labelling

Currently, a device which undergoes a conformity assessment under the UK MDR must be labelled with the UKCA mark. It is proposed to remove the requirement to physically affix the UKCA mark for devices that have been through the UK MDR conformity assessment process. The conformity assessment process itself will remain the same, but the device and its labelling will no longer require a UKCA mark.

The MHRA’s reasoning for this proposal is two-fold:

(a) Requiring manufacturers to produce a separate line of UKCA marked devices could be a disproportionately costly barrier to access the relatively small GB market.

(b) Following a positive response in the 2021 Consultation, the MHRA intends to introduce requirements to assign and register ‘Unique Device Identification’ (UDI) numbers to devices. Such requirements would improve the traceability of medical devices and render physical UKCA marks superfluous.

Removal of the UKCA marking would also ensure consistency across the market and avoid user confusion, given that products authorised via the International Recognition procedure will not bear a UKCA mark.

4. Assimilated EU law

Four EU regulations (below) are due to expire on 26 May 2025. As these are still in use and have not yet been replaced with new UK law, the MHRA proposes to remove the revocation date so the laws will remain in force until they are replaced by an updated UK medical devices regime. This is essentially housekeeping to avoid disruption.

• Commission Decision 2002/364 on the common specifications for in vitro diagnostic medical devices;
• Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices;
• Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilising tissues of animal origin; and
• Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies.

Next steps from the MHRA

The consultation is open until 5 January 2025.

We understand that in Q1 2025, the Government intends to table secondary legislation implementing the changes described in this consultation and the various changes from the previous consultation. The cumulative changes will be very pervasive. As stated previously, many of the changes are intended to harmonise the UK regulatory framework with the EU MDR and the EU IVDR.

The MHRA intends to run further consultations focusing on specific legislative measures, such as the expansion of digital labelling and health institution exemptions.

Keep an eye out for Hugo Kent-Egan’s article to delve into the consultation in more detail.

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^1. Regulation (EU) 2017/746 on in vitro diagnostic medical devices