The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January 2025, asked for input on international reliance procedures, removing UKCA marking requirements, classification of in vitro diagnostic devices and retaining assimilated EU law following Brexit.
Brexit saw the UK leave the EU’s regulatory framework for medicinal products and medical devices. This has posed challenges but also offered new opportunities for the MHRA to re-examine the regulatory framework and find new ways to increase patient access in the UK. They began this process with a 2021 consultation on changes to the Medical Devices Regulations 2002, which transpose EU directives into UK national law. The Independent Medicines and Medical Devices Safety Review, published in 2020, examined three specific case studies and provided recommendations on increasing patient safety: these recommendations also informed this consultation. They have since narrowed their focus to five key topics:
- Introducing a new international reliance process.
- Removing UKCA markings from devices.
- A new classification system for in vitro diagnostics.
- Removing the expiry date for EU assimilated law.
International Reliance
The MHRA proposes introducing an alternative to the current UK Conformity Assessment (UKCA) or CE marking process for placing medical devices on the market.
The proposed framework would allow medical devices approved by certain other countries to be placed on the GB market without requiring the UKCA marking or certification. Routes to market are defined in the consultation, with differing requirements based on device class and risk.
The MHRA has selected their comparable regulator countries/jurisdictions based on population similarity, market size and pre-market regulatory requirements. The current proposal includes Australia, Canada, the EU and the USA, but the MHRA is in active discussions to extend this to Japan, so there is scope for the reliance process to expand further.
An international reliance procedure has the potential to offer significant benefits to medical device manufacturers and GB patients. If implemented, this reliance process could significantly speed up placing a medical device on the GB market, particularly for low-risk devices and in-vitro diagnostics.
Update – 22 July 2025
Three of the four proposed routes to market will be implemented, allowing certain devices to go through a streamlined review process by relying on assessments performed in Australia, Canada, the EU or the USA. This will include specific software as a medical device and implantable devices that meet GB equivalence criteria.
One of the proposed routes will not be implemented: this was related to CE-marked devices. The approach to CE-marked devices will be the subject of future consultation, and the international reliance routes will not be implemented for CE-marked devices while that consultation process continues.
UK Conformity Assessment (UKCA) markings
The MHRA has proposed removing the requirement that devices assessed via the UK conformity assessment process bear a UKCA marking.
This marking indicates that the device meets the requirements of the Medical Devices Regulations 2002. The UKCA marking poses a potential barrier to market for manufacturers, who are required to maintain a separate line of UKCA-marked products for the relatively small GB market. The marking also does not act as a unique device identifier (UDI) – the MHRA proposes that a UDI be required and registered with the MHRA for all devices marketed in Great Britain.
Removing the requirement for devices to carry a UKCA marking offers similar benefits. It will make it far easier for manufacturers to supply the GB market, as they won’t be required to maintain a separate line of UKCA-marked products.
Update – 22 July 2025
Support for removing UKCA markings was high with general agreement that the UKCA marking requirements were a barrier to trade and market access. The government intends to remove the UKCA marking requirements for devices and their associated labelling, where the device has been through the UK conformity assessment process.
However, removal will be conditional on the device carrying a UDI, which must be searchable in a public-facing database. This means that UKCA markings will be required until that database is operational and the transitional period for the introduction of UDI is concluded.
In vitro diagnostic (IVD) devices
A new classification system for IVD devices is proposed, based on patient and public health risk.
The MHRA identified three key priorities in the 2021 consultation on IVD device classification:
- Proportionality of risks and regulatory requirements.
- MHRA alignment with EU IVDR and IMDRF standards.
- Sufficient coverage of digital/software aspects of IVD devices.
The MHRA has therefore proposed classifications which align more closely with the EU’s IVDR and the IMDRF’s standards, using a risk-based approach to classify IVD devices.
They have also proposed changes to the conformity assessments for classification, which are tied to the risk-based classifications. These are closely aligned with the EU requirements, although the MHRA believes their proposed regulatory requirements are more risk proportionate. This would mean that Class B devices would not align completely with EU law and, therefore, could not be placed on the market in Northern Ireland unless they underwent CE conformity assessment by a notified body.
Update – 22 July 2025
The government intends to adopt the risk-based framework described in the consultation. Concerns were raised about the differing conformity assessment routes for Great Britain and Northern Ireland, and ‘active measures’ will be taken to address these. CE marked devices will also be subject to a further consultation, as those devices will have a pathway to the GB market until 2028/30. Further updates will be provided on the version on ISO 13485 standard that QMS certifications will need to comply with and the feasibility of recognising MDSAP. The introduction of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 will also improve on-market surveillance.
Assimilated EU Law
The Medical Devices Regulations 2022 transpose EU law into domestic law, making them ‘assimilated EU law’.
These laws are due to expire in May 2025, before any new regulation would be in force. The MHRA proposes that the expiry date for these laws be removed, so that they would remain in force.
Update – 27 February 2025
The MHRA said on 26 February that they received an ‘overwhelmingly positive’ response to this question – in fact, 83% of people said the regulations should not be allowed to expire. In response, they’ve confirmed that they will be retaining these regulations in law. However, they’ve also clarified that the government does plan to replace these assimilated laws and update the regulatory framework more widely.
What should medical devices companies do now?
The MHRA are currently analysing the feedback they’ve received from this consultation. They will then release their official response, which could result in legislative changes. However, this process will take time. For example, in December 2024, new clinical trials legislation was discussed in Parliament. This followed a consultation in early 2022, the response to which was published in early 2023 – and of course that legislation is far from being passed into law, let alone coming into force!
For now, manufacturers should:
- Monitor the MHRA website for further consultations and the consultation response.
- Be ready to take advantage of new routes to market as soon as they are introduced. While the legislative process takes time, the MHRA has historically opened new schemes quickly once they are announced: manufacturers that are ready to go could gain competitive advantage.
- Make sure that their RIM system will allow them to identify which devices would be eligible for the new reliance route. This will be based on where the devices are already registered, and the device classification.