{"id":33255,"date":"2024-11-19T09:44:12","date_gmt":"2024-11-19T08:44:12","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/11\/19\/analisi-delle-tendenze-nella-sorveglianza-post-market-pms\/"},"modified":"2024-11-19T09:48:49","modified_gmt":"2024-11-19T08:48:49","slug":"analisi-delle-tendenze-nella-sorveglianza-post-market-pms","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/11\/19\/analisi-delle-tendenze-nella-sorveglianza-post-market-pms\/","title":{"rendered":"Trend Analysis in Post-Market Surveillance (PMS)"},"content":{"rendered":"

The European Union’s MDR (EU) 2017\/745 requires medical device manufacturers to adopt a systematic Post-Market<\/strong> Surveillance (PMS)<\/strong> process to ensure the safety and effectiveness of medical devices even after they<\/strong> are placed on the market<\/strong>. According to Article 83<\/strong>, manufacturers must ‘plan, establish, document, implement, maintain and update a post-market surveillance system proportionate to the class of risk and appropriate to the type of device’.<\/em><\/p>\n

Therefore, it is essential to proactively<\/strong> collect and analyse data from the use of devices on the market to maintain the balance between risks and benefits<\/strong> and identify possible preventive and corrective actions<\/strong> to protect the health of users and patients.<\/p>\n

The PMS, an integral part of the organisation’s quality management system, must include a detailed Post-Market Surveillance Plan (PMS Plan)<\/strong>, as specified in MDR Article 84. This plan should outline the methods for collecting and analysing market data, draw conclusions, and determine the actions required in the event of safety and performance issues.<\/p>\n

Trend Analysis: Definition and Functions<\/h2>\n

In this context, trend analysis<\/strong> plays a central role. As described in Article 88 of MDR (EU) 2017\/745<\/strong>, ‘Trend reporting<\/strong>‘, this analysis allows early identification of statistically significant trends in device safety and performance data, revealing potential risks.<\/p>\n

According to MDR, “Manufacturers must report […] any statistically significant increase<\/strong> in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side effects that 1) could have a significant impact on the benefit-risk analysis […] and 2) have resulted or may result in unacceptable health or safety risks to patients […] when compared to the expected benefits.”<\/em><\/p>\n

Manufacturers are therefore obliged to notify any significant increase in the frequency or severity of accidents or unforeseen side effects, if they may significantly alter the risk-benefit analysis and introduce health and safety risks.<\/p>\n

Trend analysis has several key functions:<\/p>\n