Home News & Events News overview The post-market world of Class I devices – PMS and PMCF

Anne Leijsen

Head of Medical Writing

October 20, 2016

The post-market world of Class I devices – PMS and PMCF

Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies are both an integral part of the upcoming European Medical Device Regulation (MDR), nicely aligned with the requirement to evaluate your medical device thorough the life-cycle of the product. A basic word counting approach is illustrative for the increased focus on post-market surveillance (PMS) activities: Whereas the current Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC) refer to ‘post-marketing’ and ‘surveillance’ only sporadically, you will find 88 hits on ‘post-market’ and 126 hits on ‘surveillance’ in the MDR. The need for PMS is almost obvious for higher class devices – but are you aware that this will also be required for Class I devices?!

for any device, proportionate to the risk class and appropriate for the type of device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system which shall be an integral part of the manufacturer’s quality management system.’ MDR

For each medical device, whether it is a high risk active implant or a low risk walking aid, post-marketing data shall be collected. However, this can be by many means, and the MDR outlines that the PMS system shall be proportionate to the risk class of the device. Previously, a reactive approach for lower risk devices, e.g. in the form of vigilance registries, would be acceptable, as long as strong clinical evidence for safety and performance was expected based on pre-market data. Currently, it is more likely that your Notified Body requires you to proactively collect data on the clinical safety and clinical performance of your device, regardless of its classification. After all, the user’s threshold for vigilance reporting may limit you to obtain sound evidence of ‘real-life’ safety and performance data.

‘The concept of the continuous cycle of improvement of medical devices requires the manufacturer to use results from PMS activities as feedback in the risk management process and to consider the need for corrective and preventive actions (CAPA), including changes in design and/or IFU. […] A specific approach for receiving user feedback was absent in more than half of the PMS procedures. Manufacturers should be aware that collecting user experiences of self-test in vitro diagnostic medical devices such as BGMs [blood glucose meters] requires more direct contact with the end-user.’ RIVM

A clear example is provided by the Dutch National Institute for Public Health and the Environment (RIVM), who recently reported that manufacturers of blood glucose meters, both those established on the market for a long time as well as new devices, do not gather sufficient information on user experiences. They specifically outline the importance of user experience for self-tests.

‘post market surveillance’ means all activities carried out by the manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.’ MDR

At the same time, the exact requirements for proactive data collection, e.g. on user experience, are not set and can be discussed between manufacturer and Notified Body. A manufacturer of a Class I device is not expected to perform the same type of post-market clinical investigations as those investigating a Class III device. For your Class I device your Notified Body may accept studies that are simpler in design, therewith reducing the threshold for the patient to participate and, not unimportant, reducing the associated costs to complete the investigation according to all regulations, standards and guidelines.

‘The technical documentation on post-market surveillance to be drawn up by the manufacturer […] shall be presented in a clear, organized, readily searchable and unequivocal way.’ MDR

We reported earlier that technical innovations provide the opportunity to specially design applications for tablet, smartphone or PC, thereby centralizing the patient and minimizing the visit schedules. Such approach could also be considered for PMCF activities for Class I devices: a low threshold application provided with your marketed device allows users to easily provide you with feedback on e.g. the ease of use of the device, the performance, safety incidences, or the actual indication used. An additional advantage of such technical innovations is the organized manner of data collection, providing an easy tool to share the data with regulatory authorities.

Recommendation: Factory CRO has expertise in all fields of clinical data collection: for each device class, in pre-marketing or post-marketing studies, obtained by paper methods or by web-based applications, etc. We offer the opportunity to help you design the PMS plan appropriate for your medical devices and assist you in performing the PMCF study as required for your specific medical device.

By Anne Leijsen

About the author

Anne Leijsen Head of Medical Writing

At Factory CRO, Anne is leading the medical writing team. Anne's expertise lies with Clinical Evaluations. At the same time, she has a special interest in ongoing changes in the medical device guidelines, directives and regulations in both the United States and Europe.

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