The Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on proposed changes to the regulatory requirements for medical devices before they are placed on the market in Great Britain.  It covers four key areas: international reliance, UKCA marking, in vitro diagnostic devices and assimilated EU law.  The MHRA says that the GB regime is out of step with international regulation.

The MRHA is responsible for ensuring that medical devices are safe and effective for use by patients in the UK. Medical devices are products or equipment that are used for medical purposes, such as diagnosis, prevention, monitoring or treatment of diseases or injuries. As well as the more obvious devices such as pacemakers and wheelchairs, they include apps which monitor health information. The government intends to update the regulatory framework by laying secondary legislation.

The issues of regulating software as a medical device may be of particular interest to our readers. Earlier this year, the MHRA issued a statement of policy intent which included specific 
requirements for Artificial Intelligence as a Medical Device (AIaMD), which is a subset of 
software as a medical device. However, the government does not currently intend to define AIaMD or introduce any AIaMD-specific requirements in legislation. Therefore, the proposed framework does not include specific requirements for these devices. These devices have potential to help the healthcare system with diagnosis and screening, prognosis and supporting treatment. However, AIaMD also pose specific safety challenges such as 
performance degradation and the potential for unwanted bias being built in during 
development, particularly against under-represented groups such as ethnic minorities.  

International reliance 

Medical devices and in vitro diagnostic devices (IVD devices) can use the UKCA (UK Conformity Assessed) process to access the Great Britain market either by self-certification for low-risk devices, or by conformity assessment and certification by an approved body. Approved bodies are organisations that have been designated by the MHRA to assess medical devices. In the future regulatory framework, the UKCA process would be complemented by an international reliance scheme aimed at enabling swifter market access for certain devices that have already been approved in a comparable regulator country. The consultation seeks views on the proposed scheme.

UKCA marking 

Medical devices, or their sterile pack, currently need to have a UKCA marking to be placed on the Great Britain market. The government is introducing new requirements to improve device traceability and so is seeking views on removing the current marking requirements for devices which undergo the UKCA process. 

In vitro diagnostic devices 

IVD devices will be classified in four risk classes based on the patient and public health risk they pose. Each class has different requirements for an IVD device to gain market access, according to its risk level. The consultation seeks views about the regulatory requirements to gain market access for IVD devices. 

Assimilated EU law 

The final aim of the consultation is to seek views on a proposal to remove the revocation date of four pieces of assimilated law so that they remain part of the statutory framework for medical devices in Great Britain until the transition to an updated medical devices regime.

In future, the government intends to consult further on specific legislative measures, such as the expansion of digital labelling. The consultation ends on 5 January 2025.