MHRA Updates Exceptional Use Authorisations for Medical Devices in UK

• The MHRA has updated its lists of medical devices granted exceptional use authorisations.
• New additions and removals have been made to the lists, including extensions to existing authorisations.
• Compliance officers and lawyers should monitor these changes closely for potential impacts on the supply chain for NHS and social care providers in the UK.
• The MHRA's exceptional use authorisation process aims to balance regulatory compliance with timely access to essential medical devices.

The MHRA publishes updated lists weekly to reflect any changes to exceptional use applications.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its lists of medical devices granted exceptional use authorisations. These authorisations allow manufacturers to sell their devices to the NHS and social care providers in the UK, even if they do not meet standard regulatory requirements. The updates include new additions, removals, and extensions to existing authorisations. For instance, DEU/010/2023/002 has been extended until 6 February 2027, while DEU/004/2022/003 has also received an extension until 13 February 2027. Additionally, some devices have been removed from the list of those covered by exceptional use authorisations, such as Integra CRW Precision Arc Stereotactic System - disposable head ring screws: DHRSS5 and DHRSL5. The MHRA publishes updated lists weekly to reflect any changes to exceptional use applications.

The MHRA's exceptional use authorisation process is designed to ensure a continued supply of medical devices in the UK, particularly when there is a clear clinical need and no available supply of CE marked or already derogated alternatives. The agency only considers applications where there is a genuine need for an exceptional use authorisation. These authorisations are typically issued directly to the manufacturer of the medical device and do not allow for distributor sales. The process aims to balance the need for regulatory compliance with the requirement for timely access to essential medical devices.

The updated lists of medical devices granted exceptional use authorisations are crucial for NHS and social care providers in the UK, as they ensure a continued supply of necessary medical devices. Compliance officers and lawyers should monitor these changes closely, as they may impact the supply chain for healthcare providers. The MHRA's exceptional use authorisation process is an important mechanism for ensuring that patients receive timely access to essential medical devices, even if they do not meet standard regulatory requirements.

Lawyers and compliance officers should monitor the updated lists of medical devices granted exceptional use authorisations and those no longer covered by such authorisations, as these changes may impact the supply chain for NHS and social care providers in the UK.

Source: Original reporting via GOV.UK