10 questions about post-market surveillance (PMS) requirements of the MDR
Post-market surveillance (PMS) is an important part of the regulatory framework for medical devices in Europe. The Medical Device Regulation (MDR) lays special emphasis on gathering clinical and safety-related data after the approval/CE certification process and market access.
Monitoring product performance of CE-marked products is crucial to systematically identifying risks in the practical use of the product, as some risks only become apparent when medical devices are used, stored, transported or cleaned. Only through continuous and systematic post-market surveillance can manufacturers ensure that medical devices are safe and that there are no uncontrolled risks such as defects or undetected security problems.
1. What is post-market surveillance (PMS)?
The MDR (Art 2 (60)) defines post-market surveillance as a proactive and systematic process which manufacturers implement and carry out (with other economic operators) in order to take corrective and preventive action (CAPA) in accordance with information on medical devices and their performance. The surveillance and reporting of incidents involving medical devices allows identification of problems with the design, manufacture or use of medical devices and, ultimately, enhances patient safety (read more on how reporting obligations enhance patient safety here).
The aim of the post-market surveillance system is to actively and systematically gather, record and analyse relevant data on the quality, performance and safety of a device throughout its entire lifetime. This allows manufacturers to continuously update the risk-benefit assessment and to initiate necessary measures without delay. Manufacturers are obliged to collect and assess all information about their medical devices and related devices from competitors.
2. What is the difference between post-market surveillance and vigilance?
Vigilance is only one part of the post-market surveillance system, as it refers to the reporting of (serious) incidents, field safety corrective actions (FSCAs) and recalls. It is a reactive system that deals with incidents, rather than the proactive collection of PMS data. Section 2 of Chapter VII of the MDR on vigilance defines the incidents that manufacturers have to report to the relevant competent authorities and how to submit these reports. Also, it requires manufacturers to analyse their vigilance data. Additional guidance in relation to the vigilance system currently in operation under the MDD (to complement the MEDDEV 2.12-1 rev 8 from 2013) was published in July 2019. This document refers to the new manufacturer incident report form, which already includes the IMDRF adverse event terminology, UDI (Unique Device Identification) and the single registration number as prescribed in the MDR.
3. What are manufacturers’ post-market surveillance obligations?
The conformity assessment procedures for obtaining a CE mark, as outlined in Annexes IX to XI, require that manufacturers establish and maintain a post-market surveillance process that is proportionate to the risk class and the type of the device. This means, post-market surveillance is required regardless of the classification of the medical device, but the details of the requirements differ.
Manufacturers have to base their post-market surveillance system on a post-market surveillance plan (Article 84), which is part of the technical documentation and proves compliance with the PMS requirements of the MDR. Annex III specifies the requirements and the content of such a post-market surveillance plan, which has to address the collection and utilization of the post-market information and cover at least:
- a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
- effective and appropriate methods and processes to assess the collected data;
- suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
- effective and appropriate methods and tools to investigate complaints and analyse 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 users;
- reference to procedures to fulfil the manufacturers obligations laid down 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;
- and a Post-Market Clinical Follow-up (PMCF) plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
4. What is a post-market surveillance report?
Manufacturers of Class I medical devices (incl. classes Is, Im and Ir) are required to prepare a post-market surveillance report to summarize the results and conclusions of the data gathered as defined in the PMS plan. The report includes the rationale behind and the description of preventive and corrective actions that have been taken; and it has to be updated when necessary.
5. When is a Periodic Safety Update Report (PSUR) required?
A Periodic Safety Update Report is required from manufacturers of class IIa, class IIb and class III devices. In this report, the results and conclusions of the analysis of the PMS data have to be summarized and preventive as well as corrective actions described and explained. The PSUR has to include the conclusions of the benefit-risk determination, the main findings of the post-market clinical follow-up, and the volume of sales of the device together with information on the population using the device.
The PSUR is part of the technical documentation and has to be updated regularly: at least every two years for class IIa devices and annually for class IIb and class III devices.
The PSUR of class III devices has to be submitted (through the electronic system on vigilance and post-market surveillance referred to in Article 92) to the notified body. The notified body adds its evaluation to the report and both documents will be made available to competent authorities through the electronic system. Manufacturers of implantable devices and class III devices are also required to use PMS data to update their summary of safety and clinical performance as outlined in Article 32.
Manufacturers have to make PSURs of class IIa and class IIb devices available to their notified bodies and, on request, to competent authorities.
6. What is a Post-Market Clinical Follow-up (PMCF)?
The PMCF is the systematic collection of clinical data with the aim of answering important questions about the safety or performance of the medical device and updating its clinical evaluation.
Post-market surveillance data and information has to be included in the post-market section of the Clinical Evaluation Report (CER). The process to continuously update the clinical evaluation with this data is called Post-Market Clinical Follow-up (PMCF) and outlined in Part 2 of Annex XIV. The MDR obliges manufacturers to proactively collect and evaluate clinical data from the end users of their devices to confirm the safety and performance throughout the expected lifetime of the device. This helps them ensure the acceptability of already identified risks and to detect emerging risks on the basis of factual evidence.
Manufacturers have to base their PMCF process on a PMCF plan; the findings of the PMCF have to be documented in a PMCF evaluation report, which is part of the clinical evaluation report and the technical documentation. The conclusions of the PMCF may also lead to an update of the risk management documents.
Post-market data has to be used to continually reassess the benefit–risk analysis in the CER and to update the risk management part of the technical documentation. Any regulatory action (such as recalls and notifications) has to be discussed, incidents should be displayed in a table and (serious) adverse events mentioned in detail (with a focus on the evaluation of whether an incident is device-related or not).
7. What kind of data should be collected to meet PMCF requirements?
PMCF can consist of data gathered from the vigilance system, complaints, technical information and publicly available information, and does not refer only to PMCF studies. The MDR mentions the gathering of clinical experience gained, feedback from users, screening of scientific literature as general methods and procedures of collecting relevant data. It treats the evaluation of suitable registers or PMCF studies as specific methods. The PMCF plan requires a rationale for the appropriateness of the methods and procedures a manufacturer chooses to apply.
8. What are the PMS requirements imposed by applicable QMS and risk management standards?
The ISO quality management and risk management standards also embrace the concept of PMS and Art. 83 of the MDR states that the post-market surveillance system is an integral part of the manufacturer’s quality management system.
To ensure the effectiveness of the QMS and the safety of medical devices, ISO 13485 requires a systematic post-market surveillance. Chapter 8 outlines the requirements for a continuous procedure for feedback processing which includes data from production and post-production activities. Information gathered in the feedback process has to be considered as input for risk management.
ISO 14971 requirements in the post-market phase do not focus on reporting obligations but aim to take into account PMS data to review if the probabilities and severity of possible damage are correctly estimated, the risks are fully identified and if the presumed risk acceptance criteria and benefit–risk ratios are valid.
In comparison with the MDR, the less comprehensive PMS requirements imposed by EN ISO 13485:2016 and EN ISO 14971:2012 are already obligatory, as the standards are harmonized for the Medical Device Directive.
9. What changes concerning the post-market surveillance does Eudamed introduce?
PMS requirements as well as the periodic update of the clinical evaluation already existed before the MDR came into force. But the MDR has significantly increased the post-market requirements for manufacturers and their obligation to proactively collect data and document and report the analysis of these post-market activities and data.
Greater transparency on post-market surveillance will be introduced with Eudamed’s module on vigilance and post-market surveillance and the obligation to include and update this information in the database.
10. What is the deadline for complying with MDR post-market surveillance requirements?
Post-market surveillance, vigilance and market surveillance requirements of the MDR will apply after the date of application: 26th May 2020.
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