No matter how hard you try as medical device manufacturer to make sure your device is safe and efficient, adverse events can still happen. Even the most vigorously tested medical devices have adverse events reported to the authorities. But how we figure out which events are caused by incorrect use, which events are caused by the device, and which events just happen to take place around the device but are not related to the device itself? The answer is of course through Post Market Surveillance.
Post Market Surveillance (PMS) is defined in the European Medical Device Regulation 2017/745 (MDR) as “all activities carried out by the manufacturer… to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market”. It is the single most important tool in a manufacturers toolbox to analyze and document any and all adverse events happening in situations where devices are included, and it is a mandatory process under practically every medical device regulation in the world.
Post Market Surveillance is clearly defined in the MDR in article 2. It is furthermore listed as one of the obligations of the manufacturer in article 10, and as one of the duties of the person responsible for regulatory compliance with the manufacturer in article 15. The exact requirements are listed in articles 83 and 84.
One of the new initiatives in the MDR compared to the MDD is the requirement to prepare Post Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) for medical devices – This requirement has previously only been present in the pharmaceutical world. Of these two reports, the PMSR applies only to low risk Class I devices and Class A and B In Vitro Diagnostic devices and should only be provided to the authorities on request. The PSUR applies to Class IIa, Class IIb, and Class III devices and Class C and D In Vitro Diagnostic devices, and should generally be updated at minimum every year at least.
Besides the PMSR and PSUR reports, a Post Market Clinical Follow-up (PMCF) report should also be elaborated as part of the concept of continuous clinical evaluation and lifecycle management of your medical device. The PMCF requirements are stricter and more intense than under the MDD and the guidance for PMCF has been reinforced and expanded.
Last but not least, vigilance reporting must be a strong component of any Post Market Surveillance program. When actions are taken to reduce the risk of harm and/or serious deterioration of health by the manufacturer, it is the responsibility of the manufacturer (or the Authorized Representative) to report these actions to the competent authorities in the afflicted markets. Failure to report Field Safety Corrective Actions can result in serious legal consequences.
While we can all understand the necessity of a strong and well-executed Post Market Surveillance program, the specific requirements and processes involved might not be so clear. If you want to learn more about these concepts, you can download this Cite Medical guidance document that details the different aspects of a good PMS program and includes a buyers guide to PMS services.
Click Here to Download Your PMS Buyer’s Guide