Author: Dr Shrinidhi Ballal, MDS

Designation: Clinical Evaluation Expert and Writer

According to the European Union Medical Device Regulation (EU MDR 2017/745) Post-market surveillance (PMS) are set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action. PMS is a crucial tool to ensure that medical devices continue to be safe and well-performing and to ensure actions are undertaken if the risk of continued use of the medical device outweighs the benefit. It encompasses a broad range of activities like monitoring other side effects, adverse events, product-related complaints, recalls, returns, and feedback from both users and patients. The evaluation of PMS can also highlight opportunities to improve the medical device. It is regarded as an essential component of the manufacturer’s quality management system and should be conducted for the device upon release into the market, irrespective of its CE marking.

Post-market surveillance relies on the data that can be/is to be collected. The manufacturer shall first establish the objectives of the post-market surveillance activities for each specific medical device or group of medical devices. Then, the manufacturer shall decide which sources are required to fulfil these objectives. Based on this, the data shall be collected and analysed. They can be divided into proactive and reactive sources.

Endeavours are meant to anticipate and curtail events before they occur. Here information is actively sought to gain insight and data into the real-world performance of the device.

Scientific literature: The additional risk or clinical data/performance evaluation results that cannot be identified in the existing documentation can be obtained from scientific literature related to the medical device where it can offer clinical evidence to the manufacturer of similar medical devices. The published information’s value and scientific validity can vary and should be assessed based on several factors, such as the publication should specify whether its focus is the organization’s medical device, a similar device, or one with shared similar characteristics, detail the study’s methodology, and indicate if it has undergone peer review.

Publicly available information about similar medical devices: Information regarding events with similar medical devices may be found in adverse events databases. Such data collection can provide insight into events that could occur with the medical device for which the post-market surveillance plan is appropriate. The adverse event databases of certain regulatory bodies (such as DAEN in Australia, Med Sun, or MAUDE in the USA) are publicly accessible.

Medical device registries: These are the tools used for the identification and study of the medical device. Among its various uses are comparative safety and effectiveness evaluations, including those in understudied subpopulations, short- and long-term surveillance, and the fulfilment of post-market observational study commitments for regulatory bodies. They make it possible to evaluate medical device performance in real-world settings. Registries offer a critical platform for documenting the experience with a medical device throughout its life cycle since they contain data on a large number of patients receiving care in various clinical settings as well as clinical outcomes over time.

Retrieval studies on explants: Studying retrieved surgical implants, surrounding tissues, and related fluids can help identify the reason behind a clinical complication or surgical implant failure, enhance understanding of surgical implant performance and safety, and improve knowledge on how surgical implants interact with human tissues and develop materials with improved tissue compatibility and implants with improved functional longevity.

Conferences and Tradeshows: Provide an opportunity for organizations to interact with users or non-users of their medical devices that can bring important feedback on the medical devices, and the satisfaction of users, including the driving forces in favour or against the adoption of the technology, the competition.

Post-Market Clinical Follow-Up (PMCF): After a medical device has obtained approval for marketing a PMCF study will be conducted to address concerns about its clinical safety or performance (i.e., residual risks). The protocol of PMCF must ensure the high quality of the clinical data collected.

User feedback via training program: To prevent the misuse of medical devices and to shorten the learning curve on how the device has to be used, an organization may choose to train the users. This may be required to mitigate the identified risks, and it is especially important when it comes to innovative medical devices, necessitating the users to adapt their medical practices.
User feedback might be passively received or actively gathered in the form of an inquiry.

Responding after an event, which can take many different forms, from complaints to cases involving serious injuries or, in the worst situations where a serious injury or death has occurred, is known as “vigilance.” It is done through the collection and evaluation of feedback.

Customer complaints and warranty claims: The complaint communicates a flaw in the identity, durability, reliability, quality, safety, and performance of the medical device. They should be handled one at a time as they are often individual cases.

Review of service reports or maintenance reports: It covers repairs, refurbishing, and preventative maintenance /corrective maintenance. Details on medical device type, medical device identifier (e.g. lot, batch, serial number), medical device configuration, user location, infrastructure, failure mode, acceptance activities, updates implemented, parts replaced (identity, number), usage of the medical device, servicing personnel, date of servicing should be included in the record.

Social media: Social media platforms facilitate the sharing of ideas and opinions. Most of them are not moderated, and even when they are, the truthfulness of the information published is not guaranteed. Verifying the accuracy of content on social media can be challenging. As a result, information on social media should be used carefully.

Information from trend reports: The effectiveness of the medical device will be assessed using data from complaints, corrective action and preventive action, including root causes. When there is a notable rise in non-serious occurrences or anticipated unfavourable side effects that could significantly affect the benefit-risk analysis, a trend report will be produced.

Serious incidents and adverse event reports: The Quality Management System (QMS) Complaint Records will be used as the source for serious incidents and adverse event reports. Information regarding events with similar devices may be found in adverse events databases. Identifying potential hazards applicable to a medical device or prioritizing identified risks based on their apparent prevalence can be made possible by information on adverse events related to similar medical devices.

Field safety corrective actions (FSCA): It is triggered by information about the occurrence of one or more incidents with already distributed medical devices that pose an unacceptable increase in risk when that device is used. Such incidents may include malfunctions or deterioration in the safety, quality or performance of a medical device made available on the market, any inadequacy in the information supplied by the manufacturer and undesirable side effects. The manufacturer should report any FSCA to the relevant National Regulatory Authorities (NRAs) where the medical device is supplied if required by national legislation.

Conclusion

Post-market surveillance (PMS) is a critical component of the product lifecycle, particularly in industries like medical devices and pharmaceuticals. It involves monitoring the safety and performance of a product after it has been released to the market. Effective PMS ensures that potential issues are identified and while reactive PMS deals with issues as they occur, guaranteeing prompt correction and compliance, proactive PMS helps avoid possible problems by utilizing innovative technology and systematic monitoring addressed promptly, safeguarding consumer safety and maintaining regulatory compliance. By balancing these approaches, companies can uphold high standards of quality, protect their brand reputation, and contribute to consumer well-being.

References:

• World Health Organization. Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics.
• Medical devices- post-market surveillance for manufacturers (ISO/TR 20416:2022).
• REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.