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), similar to FDA’s approach for high risk devices.
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.
The updated purpose of PMS activities is to capture real-world data to inform risk-benefit evaluation of medical devices. When properly developed and implemented, these activities provide actionable insights to improve the safety, tolerability, and usability of medical devices.
Overall, the MDR requires medical device manufacturers to take a more active role in post market surveillance activities. Articles 83 to 86, as well as Annexes III and XIV Part B, outline the specific responsibilities that device companies must now take on in order to commercialize and maintain their products on the EU market.
Article 83 states PMS “shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions..”
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.
Article 10 (9) further spells out that the quality management system shall “cover all parts and elements of a manufacturer's organisation 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 provisions of this Regulation.”
While the new 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.
Additive Requirements for Each Class:
Article 86 of the EU MDR details that the PSUR must include the conclusions of the benefit-risk determination, the main findings of the Post Market Clinical Follow-up (PMCF), the sales volume of the device, and an estimate of the size and other characteristics of the population using the device including frequency of use when applicable.
Manufacturers of Class IIa devices must update the PSUR at least every 2 years, while manufacturers of Class IIb and III devices must update the PSUR at least annually. The PSUR must be part of the technical documentation, except for custom-made devices which have separate documentation requirements.
Annex III expands on the requirements denoted in Articles 83-86, specifying the elements that medical device manufacturers need to include in their post market surveillance plans (PMSPs). First, the Annex stipulates that a PMSP should outline the collection and future utilization of data, with particular interest paid to:
Second, Annex III states that a PSMP must cover at least the following:
Under the updated MDR guidance, solicitation of post-market clinical data is understood to be a continuance of pre-market clinical research. In other words, medical device manufacturers should view clinical data collection as an ongoing process that does not cease to be an obligation when their device hits the European market.
When conducting PMCF, manufacturers should proactively collect and evaluate clinical data from the use of their device in or on humans with the aim of confirming its safety and performance over its expected lifetime, as well as ensuring the continued acceptability of any identified risks and detecting emerging risks.
All PMCF activities must be performed in accordance with a documented PMCF plan. That plan should specify the methods and procedures for collecting and evaluating clinical data, with the ultimate aim of:
Under Annex XIV Part B, a comprehensive PMCF plan must include:
Ultimately, it is the device manufacturer’s responsibility to analyze PMCF findings and document those results in an evaluation report. This report will then be part of the final clinical evaluation report as well as the device’s technical documentation.
Most importantly: if PMCF identifies a need for preventative and/or corrective measures, it is the device manufacturer’s responsibility to implement them.
Medical device manufacturers looking to commercialize their products in the EU can reach out to the regulatory affairs experts at Kapstone Medical. We’ll take you beyond the bullet points to evaluate how the MDR will impact your company, and find the most streamlined path to compliance. Get in touch today!