Do most medical device manufacturers with products on the market in Europe realize they must possess procedures for post-marketing surveillance (PMS)? Recently, a few manufacturers have received non-conformity assessments during their notified body audits because their quality system procedures did not include a proactive post-marketing surveillance system. So what is post-marketing surveillance and what constitutes proactive?
All conformity assessment procedures (as well as medical device quality systems) require the manufacturer to possess a post-marketing surveillance (PMS) system regardless of the classification of the medical device. Post-marketing surveillance is defined in the European Unions' Medical Device Directives (and other directives such as the Active Implantable Medical Device Directive and the In-Vitro Diagnostics Directive, as the following:
An undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase including the provisions referred to in Annex X.
There are many terms to describe it, but for this article, the term promulgated by the European Forum of Notified Bodies Medical Devices (NB-MED) will be used. A PMS system should allow a manufacturer (through the company's procedures) to collect, review and assess all information about the device, and related competitor's devices, once the device has CE marking and is on the market. Clearly, vigilance is a seminal component of PMS, but the topic of PMS has been more globally addressed since the guidance on vigilance was discussed released.
Don't all manufacturers want to collect data on their devices once they are on the market? NB-MED, produced a guidance (2.12.1) on PMS. The group discussed possible achievements of such a system: detection of manufacturing problems; improvement of medical device quality; verification of risk analysis; intelligence of long-term performance; chronic complications; performance trends; performance in different user populations and mechanisms the device may be misused; feedback on indications for use, instructions for use; training required for users; use with other devices; customer satisfaction and market performance and sustainability; and identification of incident reports (and field safety corrective action reports).
Here is a convincing vignette in the guidance: A manufacturer of intraocular lenses collected numerous complaints from users about broken lenses.
The manufacturer assessed the complaints and deemed them statistically significant. After investigation, it was deduced that the cases in which the lenses were transported were placing increased pressure on the lenses resulting in breakage. The specifications were adjusted, and the situation corrected "thereby reducing breakage, increasing user satisfaction and reducing costs." All benefits aside, PMS is a regulatory requirement for all manufacturers placing devices on the market in Europe.
Manufacturers must possess these systems. Notified bodies are charged with ensuring an effective system exists. These PMS systems may be directly proportional to the risk associated with the device based on its indication for use and the risk assessment. What are the sources of PMS? There is a reactive and proactive list in the annex of the NB-MED guidance. Proactive implies the manufacturer is actively engaging in activities to collect information about their devices. This is not an exhaustive list of PMS data, and not all may be considered appropriate for the particular medical device: literature reviews, patient registries, customer complaints, customer surveys, expert user groups, user reaction during training programs, media, trade shows, maintenance/service reports, field evaluation, retrieval studies on explants or trade-ins, in-house testing and failure analysis. Also, if the manufacturer produces similar devices, this should be considered. Don't forget to perform similar activities for a competitor's similar devices and to review regulatory authorities' databases on incidents. PMS data is any information obtained about the device once it possesses a CE mark.
A few comments should be emphasized. PMS also should be proactive, and the manufacturer should document compliance. Notified bodies are verifying that evidence exists. The manufacturer's PMS procedure should discuss the information that will be collected and obtained as part of the PMS system.
The PMS procedure also should assign departments or positions as responsible for performing a particular function. A manufacturer may find it helpful to have a PMS report at the end of the year, as well as a PMS tracking schedule and log. As an example, the intraocular lens manufacturer has determined that there are many salient journal articles in the Journal of Refractive Surgery. The manufacturer assesses the frequency (the journal is published monthly) and develops a schedule and log for the publication. When the individual tasked with this review has evaluated a particular month's issue, he or she documents it so there is evidence even if a particular month's issue did not contain any relevant articles. This intraocular lens manufacturer attends various trade shows, and their attendance and the information obtained could be documented as PMS. This information could constitute feedback received from users or information obtained from discussions with users or other manufacturers. At the end of the year, the intraocular lens manufacturer might compile all the information collected reactively and proactively into a PMS report.
A blog post from a notified body auditor provides insight into a question a notified body auditor may ask to test the effectiveness of a manufacturer's PMS system. Roland Cooke, a regulatory services specialist for SGS, a notified body, shared the following question he typically asks: "If your competitor's similar device had problems in the field, how would you learn about those problems? Then, how would you determine if those problems might also affect your devices [i.e., possibly in the very near future]?"
The response should align with the manufacturer's PMS procedure.
The information obtained from a manufacturer's PMS system should be communicated, at a minimum, annually during a management review meeting-which is top management's examination of the organization's quality management system. Further, this information also may be incorporated as part of the risk management process.
Manufacturers should understand that a PMS system is a regulatory requirement. This system should have reactive and proactive elements, and compliance should be demonstrated and documented. PMS data is so integral to a manufacturer's success that the procedures should similarly reflect the manufacturer's commitment to collecting and reviewing this information.
Originally published in October 2009