MHRA publishes guidance on new UK medical device post-market surveillance requirements

The suite of guidance can be accessed here, and includes:

• Guidance on the implementation of the PMS Regulations. Together with this guidance the MHRA has prepared a set of helpful summary tables flagging key changes and requirements applying to different devices, considering the risk-based approach taken in the PMS Regulations.  These tables are a useful starting point for understanding how the PMS Regulations will impact each device.

Key issues covered by this guidance are: (i) clarification of key terms, such as ‘lifetime of a device’, ‘post-market surveillance period’ and ‘serious incident’; (ii) requirements for the PMS plan, which is now mandatory, and clarification on the nature of feedback that should be obtained from patients and the public on the device as part of the PMS plan; (iii) confirming that risk management may align with ISO 14971: Medical devices – application of risk management to medical devices; (iv) requirements for Post Market Surveillance Reports (PMSRs) and Patient Safety Update Reports (PSURs), including timescales based on device risk classification; and (v) how to report serious incidents to the MHRA. 

• Supplementary guidance on a manufacturer’s vigilance system: The focus of this guidance is on field safety corrective actions (FSCA), with templates for field safety notices as well as confirmation of the MHRA’s approach when receiving FSCAs.
• Periodic safety update reports (PSUR): This guidance covers when Approved Bodies have obligations in relation to PSURs, the process Approved Bodies must follow when assessing PSURs and whether updates to technical documents are required following a PSUR.  The guidance confirms that device certification can be withdrawn or suspended if a manufacturer consistently fails to provide the Approved Body with the minimum required information in a PSUR or to submit the PSUR.
• Device-specific vigilance guidance: This provides specific guidance on adverse incidents and adverse event reporting for particular types of devices (such as blood glucose meters, intraocular lenses, breast implants, insulin pumps and others).

Manufacturers are encouraged to start aligning their PMS practices with the MHRA’s guidance in anticipation of the PMS Regulations being passed into law and taking effect.  The MHRA is open to receiving any feedback on the new guidance documents through trade associations.

Authored by Jane Summerfield and Alexandra Wood.