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.  

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. 

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. 

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. 

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.