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.
What is the purpose of post market surveillance?
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.
What has changed under EU MDR?
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: Active Role of Manufacturers
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..”
A Comprehensive QMS
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.”
Obligations by Risk Class
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:
- Class I: 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
- Class IIa & IIb: In addition to Class I requirements, prepare a Periodic Safety Update Report (PSUR) for each device. More information about the PSUR can be found below
- Class III & Implantable Devices: In addition to Class I, IIa, and IIb requirements, draw up a summary of safety and clinical performance that will be made public through EUDAMED, the EU’s medical device database
Article 86: Periodic Safety Update Report (PSUR)
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: Technical Documentation on PMS
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:
- Information concerning serious incidents, including that from 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, including feedback and complaints, provided by device users, distributors, and importers
- Publicly available information about similar medical devices
Second, Annex III states that a PSMP must cover at least the following:
- A proactive and systematic process to collect any of the information outlined above, that also allows for correct characterization of device performance as well as for comparisons to be drawn between the device and similar products available on the market
- Effective and appropriate methods/processes to assess the collected data
- Suitable indicators and threshold values that shall be used in continuous risk-benefit reassessment
- Effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field
- Methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period
- Methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators, and device users
- Reference to procedures that fulfill device manufacturers’ obligations as outlined in Articles 83, 84, and 86
- Systematic procedures to identify and initiate appropriate measures including corrective actions
- Effective tools to trace and identify devices for which corrective actions might be necessary
- A Post-Market Clinical Follow-Up (PMCF), or justification as to why one is not applicable
Annex XIV Part B: Post-Market Clinical Follow‐up (PMCF)
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:
- Confirming the safety and performance of the device throughout its expected lifetime
- Identifying previously unknown side effects and monitoring identified side effects and contraindications
- Identifying and analyzing emerging risks on the basis of factual evidence
- Ensuring the continued acceptability of the benefit-risk ratio (as outlined in sections 1 and 9 of Annex I)
- Identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose of such uses is correct
Under Annex XIV Part B, a comprehensive PMCF plan must include:
- The general and specific methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, and screening of scientific literature and of other sources of clinical data
- Rationale for the appropriateness of those methods and procedures
- Reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I
- The specific objectives to be addressed by the PMCF
- An evaluation of the clinical data relating to equivalent or similar devices
- Reference to any relevant CS, harmonized standards when used by the manufacturer, and relevant guidance on PMCF
- A detailed and adequately justified time schedule for PMCF activities
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.
Get Advice from Medical Device Experts
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!