Part 6 in a 7-part series on the EU’s Medical Device Regulation
The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance (PMS) and post-market clinical follow-up (PMCF) that moves closer to the FDA’s approach.
The FDA defines PMS as the process of “active, systematic, scientifically valid collection, analysis and interpretation of data and other information about a marketed device.”
Similarly, the new MDR was specifically updated to ensure that manufacturers do not passively wait for information to come to them, but instead, actively seek out and review information.
Article 75 states “Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities.”
To that end, all manufacturers need to establish a comprehensive quality management system and post-market surveillance system that is proportionate to the risk class and type of device to be marketed. Such PMS includes a system for feedback and interfacing between risk management, incident reporting, and field safety corrective and preventive actions (CAPA) taken.
The regulation further spells out what is meant by “comprehensive” requiring that the quality management system shall cover all parts and elements of a manufacturer's organization dealing with the quality of processes, procedures, and devices. “It shall govern the structure, responsibilities, procedures, processes, and management resources required to implement the principles and actions necessary to achieve compliance with the Regulation.”
That said, while these PMS requirements apply to all classes of medical devices, according to Obelis European Authorized Representative Center, the obligations under the MDR increase with the risk class of the device:
- Manufacturers of class I devices shall prepare a post-market surveillance report summarizing the results and conclusions of the analyses of the PMS data and any corrective or preventive action taken
- Manufacturers of class IIa, class IIb, and class III devices shall prepare a Periodic Safety Update Report (PSUR) of each device, which shall set out conclusions of the benefit-risk determination, main findings of the post-market clinical follow-up (PMCF); and the volume of sales. The PSUR for class IIb and III shall be updated annually; and for class III and implantable devices submitted to the Notified Body
- Manufacturers of implantable devices and class III devices shall also draw up a summary of safety and clinical performance, which will be made public through EUDAMED, the EU’s medical device database
In addition, the MDR specifies the information to be included and the frequency of periodic safety update reports (PSUR) under Article 81 and Article 82 that applies throughout the life cycle of the device.
The report must include the conclusions of the benefit-risk determination, the main findings of the Post Market Performance Follow-up, the volume of sales of the device, and an estimate of the size and other characteristics of the population using the device including frequency of use when practicable.
The frequency of reporting also roughly increases with the device class, according to Oriel Stat. PMSRs for Class I devices can be filed when necessary. PSURs for Class IIa can be filed at a minimum of every two years, Class IIb (non-implantable) and Class III at minimum of every year.
If you are looking for help with how the EU’s MDR affects your organization, Kapstone Medical has the experience and expertise to assess your product portfolio, quality management system procedures, and design history files. Contact us for more information.
Sources: EUR-Lex Access to European Union Law; FDA CFR - Code of Federal Regulations Title 21; Obelis European Authorized Representative Center; Oriel Stat A Matrix, What is the Difference between PSUR and a PMSU?