Why Risk Management doesn’t stop after Market Launch
For medical device manufacturers, achieving CE marking is a significant achievement, but it is not the end of the process. According to the EU Medical Device Regulation (MDR) and EN ISO 14971, Risk Management must continue beyond product launch to ensure ongoing safety, performance, and compliance.
A robust Risk Management System (RMS), as required by MDR Article 10 and Annex I, extends across the entire product lifecycle. This includes proactive monitoring through Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF).
While the Risk Management Plan identifies and mitigates risks before market entry, PMS and PMCF processes ensure that these measures remain effective in real-world use. Manufacturers must continuously collect and analyse data to confirm that the benefit-risk ratio remains acceptable. This includes user feedback and incident reports, registry data, and clinical studies.
The PMS and PMCF findings provide direct input to the Risk Management File, prompting updates to technical documentation and, when necessary, corrective actions. This iterative approach transforms compliance from a static requirement into a dynamic cycle of continuous improvement.
At WQS, we support manufacturers in designing and maintaining fully compliant systems for Risk Management, PMS, and PMCF, from planning and documentation to implementation. Because true product safety doesn’t stop after market launch. It evolves with every patient, every use, and every insight.
Learn more about our Risk Management and Post-Market-Surveillance services.
