MHRA Field Safety Notices – Guidance for Manufacturers

The MHRA has published guidance for manufacturers of medical devices concerning field safety notices. The guidance includes advice regarding the steps to ensure good traceability, and advice concerning various elements of Field Safety Notices (FSNs). These include:

• Content;

• Purpose and design;

• Maximizing efficacy of communication, including distribution and follow-up;

• Inclusion of unique device identifiers;

• Effective targeting of FSNs and maximizing response rates;

• Strategy for Field Safety Corrective Actions (FSCA); and

• Confidentiality of FSNs.

A separate section of the guidance offers advice concerning custom-made medical devices – including the steps to fulfil related key requirements.

Finally, the guidance includes an overview of the steps taken by MHRA to address FSCAs, including the review and monitoring of FSNs.