MHRA Guidance: Non UKCA Marked Medical Devices Compliance

Understanding Non UKCA Marked Medical Devices Compliance and Exceptional Use Authorisation

Recent updates released by the Medicines and Healthcare products Regulatory Agency (MHRA) outline the exceptional circumstances under which non UKCA marked medical devices compliance can be maintained within the UK. Under the UK Medical Devices Regulations (UK MDR 2002), this marks a significant pivot in regulatory compliance aimed at maintaining patient safety and device efficacy justification.

The MHRA guidance medical devices framework specifies conditions under which manufacturers or a designated UK Responsible Person (UKRP) can submit an exceptional use authorization (EUA) application. This MHRA derogation application allows companies to supply non-UKCA marked medical devices in the UK, primarily focusing on scenarios where demonstrating lack of compliant alternatives is clear and no suitable UK Conformity Assessed (UKCA) marking options exist.

Stakeholders must understand the complete application process, the strict criteria for MHRA's authorisation, and the technical documentation required to support claims of exceptional need. This includes thorough risk analysis and hazard identification to safeguard medical device supply chain protection.

These updates have broad implications across the CE mark transition GB market, whether handling a humanitarian use device application, managing custom-made medical devices UK requirements, or ensuring broader product availability for healthcare providers and patients.

To ensure thorough comprehension and adherence to these evolving requirements, PharSafer® can provide a full assessment of the guidance. Learn more about how our PharSafer Services, including our specialized Pharmacovigilance Service, tailored Regulatory Strategy Service, and automated regulatory reporting with RAPTAR, can help keep your device operations fully compliant.

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.