The European Union’s MDR (EU) 2017/745 requires medical device manufacturers to adopt a systematic Post-Market Surveillance (PMS) process to ensure the safety and effectiveness of Medical Devices even after they are placed on the market. According to Article 83, 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’.
Therefore, it is essential to proactively collect and analyse data from the use of devices on the market to maintain the balance between risks and benefits and identify possible preventive and corrective actions to protect the health of users and patients.
The PMS, an integral part of the organisation’s quality management system, must include a detailed Post-Market Surveillance Plan (PMS Plan), 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.
Trend Analysis: Definition and Functions
In this context, trend analysis plays a central role. As described in Article 88 of MDR (EU) 2017/745, ‘Trend reporting‘, this analysis allows early identification of statistically significant trends in device safety and performance data, revealing potential risks.
According to MDR, “Manufacturers must report […] any statistically significant increase 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.”
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.
Trend analysis has several key functions:
- Early identification of risks: allows early detection of security risks.
- Preventive and corrective actions: detected trends may lead to decisions on device modifications, updates to user manuals or other actions.
- Active surveillance: demonstrates to the authorities that the manufacturer actively monitors the device and takes the necessary measures to maintain its original safety and performance.
Data Sources and Information Collection
For an accurate trend analysis, data can be derived from various processes and multiple corporate and non-corporate sources, generally:
- Customer feedback
- Log files
- Specialist Literature
- Installation and Service Logs
- Customer Surveys
- Customer Complaints
Manufacturers must define data sources and targets for each attribute detected (e.g. type of hazard, person who reported the problem). Feedback should be evaluated early to prevent incidents, while more detailed statistical analyses can be carried out periodically (e.g. quarterly).
Methodologies and Application
Trend analysis requires the use of appropriate statistical methods to detect significant changes. Faced with the data collected, manufacturers have to go through several decision-making stages, asking themselves some key questions, first of all:
- Is the increase in the frequency or severity of incidents significant?
- Does the risk-benefit ratio remain acceptable?
A significant increase must be assessed concerning the foreseeable frequency and severity of incidents, as indicated in the technical documentation. Manufacturers must compare the current data with the original data from the risk analysis and establish threshold values to define the extent of changes requiring action.
Impact and Documentation
The implementation of trend reporting provides valuable information on device performance, safety and effectiveness. By monitoring trends, emerging issues can be identified that require further investigation or corrective action, while maintaining a favourable benefit-risk ratio.
The results influence other parts of the post-market documentation, such as updates to the device or user manuals, demonstrating a proactive approach to the authorities. The Periodic Safety Update Report (PSUR) – mandatory for Class IIa, IIb and III devices – includes trend analysis data.
Conclusions and Implications for Manufacturers
The data derived from the trend analysis are crucial for decisions that may determine the updating of device design and manufacturing data, instructions for use and labelling, clinical evaluation and a summary of safety and clinical performance (SSCP).
Trend analysis should not only be seen as a regulatory obligation but as a useful tool to improve company, customer and product knowledge to achieve greater competitiveness in the market.
On our website you can find the following templates used by Thema in the management of post-market activities:
