Understanding the Exceptional Use of Non-UKCA Marked Medical Devices

Recent updates released by the MHRA outline the exceptional circumstances under which non-UKCA marked medical devices may be utilised within the UK, marking a significant pivot in regulatory compliance aimed at maintaining patient safety and device efficacy.

The guidance specifies conditions under which manufacturers can apply for MHRA authorisation to supply non-UKCA marked medical devices in the UK, primarily focusing on scenarios where no suitable UKCA-compliant device alternatives are available.

Stakeholders must understand the application process, the criteria for MHRA's authorisation, and the documentation required to support claims of exceptional need and lack of alternatives.

This update has broad implications for manufacturers, healthcare providers, and patients, potentially affecting the availability of medical devices and necessitating a strategic approach to compliance and product planning.

To ensure thorough comprehension and adherence to the new regulatory requirements, PharSafer® can provide a full assessment of the complete guidance.

When interpreting these updates and their implications for your safety operations, should you have questions or require assistance, please do not hesitate to contact us for expert guidance and support.