Monitoring the product performance of CE-marked devices is critical to systematically identify risks in the practical use of the device, as some risks only become apparent during the use, storage, transport or cleaning of medical devices. Only through continuous and systematic surveillance can manufacturers ensure that their medical devices are safe and that no uncontrolled risks exist.
1. How is post-market surveillance defined?
The MDR defines post-market surveillance as a proactive and systematic process that manufacturers implement and perform (along with other economic operators) to derive preventive or corrective actions (CAPA) from information about medical device use and performance. Monitoring and reporting of medical device incidents allows for the identification of problems in the design, manufacture or use of medical devices and ultimately increases patient safety (learn more about how reporting requirements increase patient safety here).
The objective of the surveillance system is to actively and systematically collect, record, and analyze relevant data on quality, performance, and safety throughout the life of a product. This enables continuous updating of the risk-benefit assessment and immediate initiation of necessary measures. Manufacturers are required to collect and evaluate all information about their medical devices and related products from competitors.
2. How do post-market surveillance and vigilance differ??
Vigilance is only one part of the surveillance system, which refers to the reporting of (serious) incidents, field safety corrective actions (FSCAs) and recalls. It describes a reactive system that addresses incidents that have occurred, rather than proactive collection of PMS data. Section 2 of Chapter VII of the MDR on vigilance defines the incidents that manufacturers must report to competent authorities, how these reports must be submitted, and requires manufacturers to analyze their vigilance data. An additional guideline for the vigilance system currently required under the MDD (in addition to MEDDEV 2.12-1 rev 8 of 2013) was published in July 2019. This document already refers to the new incident reporting form (manufacturer incident report form), Includes IMDRF terminology for adverse events, UDI (unique device identification), and the unique registration number required by the MDR. Learn more about UDI under the EU MDR here.
3. What are the post-market obligations for manufacturers?
Conformity assessment procedures require manufacturers to establish and maintain a post-market surveillance process for their medical devices that is proportionate to the risk class and nature of their devices. This means that surveillance activities are required for all medical devices, regardless of their risk class, but they differ in the nature of the requirements.
Manufacturers must base their post-market surveillance system on a surveillance plan (Article 84), which is part of the technical documentation and demonstrates compliance with PMS requirements under the MDR. Annex III specifies the requirements and content of such a monitoring plan, which shall address the collection and use of post-market information and shall include at least the following:
- A proactive and systematic process for collecting any information referred to in (a) above. The process allows for proper characterization of the products’ performance as well as a comparison between the product and similar products on the market,
- effective and appropriate methods and processes for evaluating the data collected,
- Appropriate indicators and thresholds to be used in the continuous reassessment of benefit-risk analysis and risk management as defined in Section 3 of Annex I,
- effective and appropriate methods and tools for reviewing complaints and analyzing market-related experience collected in the field,
- Methods and protocols to address the events subject to trend reporting as referred to in Article 88, including the methods and protocols to be used to detect any statistically significant increase in the frequency or severity of those events and the observation period;
- Methods and protocols for effective communication with competent authorities, notified bodies, economic operators and users;
- Reference to procedures for meeting the obligations of manufacturers under Articles 83, 84, and 86;
- systematic procedures to identify and take appropriate action, including corrective action;
- Effective tools to detect and identify devices that may require corrective action; and
- A post-market clinical follow-up plan in accordance with Annex XIV, Part B, or a justification why post-market clinical follow-up is not applicable.
Surveillance activities are required for all medical devices, regardless of their risk class.
4. What does the post-market surveillance report include?
Manufacturers of class I medical devices (including classes Is, Im, and Ir) are required to prepare a post-market surveillance report to summarize the results and conclusions of the data collected as defined in the PMS plan. The report must also include a justification and description of the preventive and corrective actions taken, which must be updated as needed.
5. When is a safety report (PSUR) required?
Manufacturers of Class IIa, Class IIb, and Class III medical devices must submit a safety report (engl. Prepare a Periodic Safety Update Report (PSUR) and update it regularly. This report must summarize the results and conclusions of the analysis of the PMS data, and describe and explain preventive and corrective actions. The safety report must include the conclusions of the benefit-risk assessment, the main findings of the assessment report and the total sales volume of the device, as well as information on persons to whom the device is applied.
The safety report is part of the technical documentation and must be updated at least every two years for class IIa devices and annually for class IIb and III devices. Manufacturers must make safety reports of class IIa and IIb devices available to their notified bodies, and upon request, to the competent authorities.
The safety report of Class III devices must also be submitted to the notified body (via the electronic post-market vigilance and surveillance system under Article 92). The notified body adds its assessment to the report and the two documents are then made available to the competent authorities via the electronic system.
Manufacturers of implantable devices and class III devices are additionally required to use PMS data to update the Summary Safety and Clinical Performance Report (SSCP) in accordance with Article 32.
6. For whom do post-marketing clinical follow-up (PMCF) requirements apply??
Post-market clinical follow-up describes requirements for the systematic collection of clinical data with the goal of answering important questions about the safety or performance of a medical device and updating the clinical evaluation.
Post-market surveillance data and information must be included in the post-market section of the clinical evaluation (CER). The process for continuously updating the clinical evaluation with these data is called "post-market clinical follow-up" (Engl. Post-Market Clinical Follow-Up (PMCF)) and described in Annex XIV, Part 2 of the MDR. The MDR newly requires manufacturers to proactively collect and evaluate clinical data from the use of their devices to confirm safety and performance over the expected lifetime of the devices. This enables acceptance of risks already identified and identification of emerging risks based on relevant evidence.
Manufacturers must base their PMCF process on a plan and document the results of clinical follow-up in the market in an assessment report, which is part of the clinical evaluation report and technical documentation. The conclusions of the PMCF may also lead to an update of risk management documents.
PMS data must be used to continuously review the benefit-risk analysis in the clinical evaluation and to update the risk management portion of the technical documentation. This must include all regulatory actions (such as e.g.B. Recalls) should be discussed, incidents should be tabled, and (serious) adverse events should be addressed in detail (with emphasis on analyzing whether an event is product-related or not).
7. What type of data should be collected to meet the requirements of the PMCF?
For clinical follow-up, vigilance system data, complaints, user feedback, technical and publicly available information must be considered. A study is not necessary in every case.
The MDR distinguishes between general (collection of gained clinical experience, user feedback, screening of scientific literature) and specific (assessment of appropriate registries or PMCF studies) methods and procedures for obtaining relevant data. The PMCF plan must include a justification for the appropriateness of the methods and procedures used by the manufacturer.
8. What PMS requirements are imposed by the applicable QMS and risk management standards?
ISO standards for quality management and risk management also encompass the concept of PMS. Article 83 of the MDR states that the PMS system is an integral part of the manufacturer’s quality management system.
To ensure QMS effectiveness and medical device safety, ISO 13485 requires systematic post-market surveillance of a device. Chapter 8 describes the requirements for a continuous procedure for the feedback process, which includes production and post-production data. Information collected through the feedback process is in turn input to risk management.
ISO 14971 requirements for PMS phase do not focus on reporting requirements. The requirements from this standard are to ensure that PMS data are considered to verify that the probabilities and severity of potential harms are correctly estimated, the risks are fully identified, and that the assumed risk acceptance criteria and benefit-risk ratios are valid.
Unlike the MDR, the less comprehensive PMS requirements of EN ISO 13485:2016 and EN ISO 14971:2012 are already mandatory, as these standards are harmonized for the Medical Devices Directive.
9. What are the changes related to post-market surveillance that Eudamed is introducing?
PMS requirements, as well as the requirement for periodic clinical evaluation updates, existed prior to the MDR. But the MDR has significantly increased PMS requirements for manufacturers, most notably the requirement to proactively collect data, document it and analyze it.
With the Eudamed module on vigilance and post-market surveillance and the requirement for manufacturers to enter and update data in the database, the MDR now creates more transparency in post-market surveillance.
10. From when must the MDR requirements regarding monitoring be met?
MDR’s requirements for post-market surveillance, vigilance and market surveillance are to be promoted from the effective date of 26. May 2021 mandatory.