Medical devices

Medical device vigilance is a critical aspect of post-market surveillance aimed at ensuring the safety and performance of medical devices throughout their lifecycle. Regulation 2017/735 establishes a framework for reporting, evaluating, and mitigating risks associated with adverse incidents related to medical devices. This vigilance system requires manufacturers, importers, and distributors to report incidents and field safety corrective actions (FSCAs) to the relevant regulatory authorities. The primary goal of this regulation is to identify potential risks as early as possible, prevent patient harm, and implement corrective measures to maintain medical technologies safe.

Under Regulation 2017/735, manufacturers have to maintain an effective post-market surveillance system that continuously monitors the performance of their devices in real-world settings. This includes collecting data from various sources such as healthcare professionals, users, and patients, and assessing whether reported incidents indicate a safety concern. In cases where an incident occurs—such as device malfunction, deterioration in performance, or labelling errors that may lead to patient harm—manufacturers are obligated to report the issue within a specified timeframe. Additionally, they have to take appropriate corrective actions, which may involve device recalls, updates to instructions for use, or modifications to the device itself to prevent further risks. 

1. Establish a Post-Market Surveillance (PMS) System: Manufacturers must set up a structured PMS system to continuously monitor the performance and safety of their devices once they are on the market. 
2. Incident Reporting: incidents involving medical devices have to be reported to the relevant competent authorities within the specified timeframes. 
3. Field Safety Corrective Actions (FSCAs): When a safety issue is identified, manufacturers have to implement corrective actions such as recalls, software updates, or modifications to prevent further risks to patients and users. 
4. Trend Reporting: If an increase in incidents or device malfunctions is observed, even if they are not classified as incidents, manufacturers have to assess trends and report them to authorities if necessary. 
5. Maintain and Update Technical Documentation: Vigilance records, PMS plans, risk assessments, and corrective actions must be properly documented and updated.
6. Develop and Submit Periodic Safety Update Reports (PSURs): Class IIa, IIb, and III device manufacturers have to submit PSURs summarizing vigilance data, risk-benefit analysis, and corrective actions to regulatory authorities. 
7. Implement a Risk Management System: An effective risk management process has to be in place, ensuring that risks associated with medical devices are continuously evaluated, mitigated, and documented throughout the product lifecycle. 
8. Communicate with Competent Authorities: Manufacturers have to maintain open and transparent communication with regulatory bodies, promptly providing required information and cooperating in investigations. 
9. Training and Internal Procedures for Vigilance: Companies have totrain employees on vigilance obligations and establish internal procedures for identifying, assessing, and reporting incidents effectively. 
10. Collaborate with Economic Operators and Healthcare Professionals: Distributors, importers, and healthcare professionals play a role in vigilance by reporting incidents and sharing safety data. Manufacturers must ensure a well-defined process for receiving and analysing this information.