Comprehensive Post Market Surveillance Solutions for Medical Devices

Post-market surveillance (PMS) is a system that provides continuous feedback on the performance of medical devices on the market, ensuring a high standard of product quality. It is an essential part of regulatory requirements, and the Medical Device Regulation (EU MDR) and IVDR post market surveillance place significant importance on collecting clinical and safety-related data after the approval/CE certification process and market access. The data gathered from medical device post market surveillance serves as critical input for updating technical documents such as clinical evaluation, Risk analysis, usability, etc.

Manufacturers of MD and IVD devices must implement a robust system to gather and review experience from their devices in the post-production phase. Notified Bodies (NB) are responsible for auditing and verifying the effectiveness of the PMS post marketing surveillance system. Such medical device post market surveillance systems are an essential part of a manufacturer’s quality assurance framework. In most cases, these systems already exist to fulfill internal company requirements, function as an integrated part of a manufacturer’s quality system, and comply with third-party regulations. Even in the absence of an approved quality system, manufacturers are still required to maintain an effective post-market surveillance (PMS) system.

A Post Market Surveillance (PMS) Plan is a documented strategy of the proactive process for the collection of any required information to evaluate the safety and performance of the medical device released in the market.

The PMS plan contains the requirements of Article 84 & Annex III of EU-MDR to be followed for the collection of data, which is directly proportional to the risk associated with the intended use of the medical device.

The EU MDR post market surveillance plan shall address the collection and utilization of available information, in particular:

• Information concerning serious incidents, including information from Periodic Safety Update Report (PSURs), and field safety corrective actions;
• Records referring to non-serious incidents and data on any undesirable side-effects;
• Information from trend reporting;
• Relevant specialist or technical literature, databases, and/or registers;
• Information from feedback and complaints provided by users, distributors, and importers; and
• Publicly available information about similar medical devices.

Additionally, for IVDR post market surveillance, manufacturers must ensure compliance with regulations applicable to in vitro diagnostic devices, ensuring all relevant data is gathered and assessed for performance and safety.

The MDR post market surveillance is designed to ensure continuous monitoring of medical devices after they have been placed on the market, helping to maintain safety standards throughout the device lifecycle.