Members have just over 2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations. This date sees a significant update to the UK Medical Device Regulation 2002 for IVDs and medical devices. Stuart Angell, Chair of BIVDA’s Regulatory Affairs Working Party, provides a rundown of what members need to know:
Systematic Data Collection: Manufacturers must establish and maintain a PMS system to actively and systematically gather data on the quality, performance, and safety of their IVDs
Periodic Safety Update Reports (PSURs): Regular reports summarizing the results and conclusions of the PMS data analysis must be submitted to the MHRA.
All manufacturers who currently place devices on the UK market (under either a CE mark or UKCA mark) should review the new regulation (and associated guidance). The main challenges include:
– Incident Reporting: Any adverse incidents involving the IVD must be reported to the MHRA promptly.
– Corrective and Preventive Actions (CAPAs): Manufacturers must implement and document any necessary corrective and preventive actions based on the PMS data.
– Trend Reporting: If there is a significant increase in the frequency or severity of incidents, manufacturers must report these trends to the MHRA.
– Field Safety Corrective Actions (FSCAs): If a safety issue is identified, manufacturers must take appropriate actions to mitigate the risk, such as issuing field safety notices or recalling the product.
Finally – don’t forgot your risk management under ISO14971! This is a critical and valuable tool to support the PMS process. You can only have an effective PMS process if you have embedded a robust risk management approach.
