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May 27, 2016

Post market surveillance – Not just a second-class clinical investigation

The clinical demonstration of safety and performance of your device is an essential premarket conformity assessment specified under Annex I, 93/42/EEC [1]. However, as with any clinical investigation, there may be limitations to the applicability of the data obtained from a controlled trial. These limitations are for example the often short duration of clinical investigations, the controlled settings and the careful selection of patients. In the ‘real world’ however, patients are exposed to your device for a longer duration, present a more heterogeneous population and may have several significant comorbidities as opposed to patients studied in a controlled trial. Clinical data obtained after your device has been placed on the market is essential not only to ensure long term safety and performance, but also to maintain high product quality and provide valuable insights to improve your device.

Post market surveillance (PMS), which refers to the activities carried out by the manufacturer, may be proactive in the form of post market clinical follow-up studies (PMCF) or can be reactive in the form of vigilance registries. For CE marking in Europe, PMCF should be part of the PMS plan of all medical devices; if no PMCF is performed, a justification is required as to why this is not being done. In the US, a PMS plan is often only required for the highest risk devices by the FDA, although in the near future PMS requirements may change for the US as well.

Recently in Europe, PMCF studies are in the spotlight as it will be an integral part of the new European Medical Device Regulation. The draft Medical Device Regulation (MDR) shows increased requirements for post market surveillance. It has been proposed that the PMCF shall be part of the manufacturer’s PMS plan, and to this end proactively collect and evaluate clinical data with the aim of confirming safety and performance throughout the expected lifetime of a device. The results should be analyzed periodically and sent to the Member States. For class III devices, these reports shall be further reviewed by third or external parties. Some manufacturers may argue that their device is similar to other devices on the market and they do not require PMCF studies, but this argument will not apply (anymore) in the MDR. Manufacturers need to have a PMS plan in place that is specific to their product or family of products.

The MEDDEV 2.12/rev2 provides guidance on how to conduct a PMCF study and details circumstances which justifies the requirement of performing one (i.e. innovation; unstudied subpopulations; risks identified from literature etc.). PMCF studies are not second-class clinical investigations, but should be carefully outlined, well designed, with clearly defined objectives. This is where the difficulty is: not all manufacturers have experience in collecting clinical data, which includes obtaining regulatory approval, access to patient medical records and collection of follow-up data.

It is important to realize that a carefully designed PMS plan is not just a regulatory requirement to have in place, but it contributes to the ongoing development, and eventually ensures long term durability, of your device.

By Amber Salomons

[1] European Medical Device Directive – Annex I, 93/42/EEC as amended by Directive 2007/47/EC

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