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 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.
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.
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.
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