This article explains how to write a post-market surveillance plan for CE Marking and how to determine if a post-market clinical follow-up (PMCF) study is required.
A post-market surveillance (PMS) plan is only required for the highest risk devices by the FDA (i.e., typically devices that require a PMA or premarket approval). For CE Marking, however, all product families are required to have evidence of post-market clinical follow-up (PMCF) studies or a justification for why PMCF is not required.
Why is a post-market surveillance plan a “hot button” with auditors recently?
Post-Market surveillance is an area of emerging concern around the world. Not just a procedure for PMS, but an actual product-specific plan for gathering post-production data about your product or product family. Product registries, the anticipated launch of Eudamed, and the implementation of UDI regulations are part of this industry-wide movement. The FDA has articulated the US plan for strengthening PMS in a guidance document. At the same time, the European PMS efforts are being debated as a central part of the new European Medical Device Regulations.
The biggest mistake I see
The biggest mistake I see is that manufacturers refer to their PMS procedure as the PMS plan for their product family, and they say that they do not need to perform a PMCF study because the device is similar to several other devices on the market. Manufacturers need to have a PMS plan that is specific to a product or family of products.
How often is post-market surveillance data collected?
Your post-market surveillance procedure needs to be updated to identify the frequency and product-specific nature of post-market surveillance for each product family, or a separate document needs to be created for each product family. For devices that are high-risk, implantable, or devices that have innovative characteristics, the manufacturer will need to perform some PMCF studies. Even products with clinical studies might require PMCF because the clinical studies may not cover changes to the device, accessories, and range of sizes. MEDDEV 2.12/2 provides guidance on the requirements for PMCF studies, but most companies manufacturing moderate-risk devices do not have experience obtaining patient consent to access medical records to collect PMCF data–such as postoperative follow-up data.
Medical Device Academy has created a post-market surveillance plan template that you can download for free. If you are looking for a procedure for post-market surveillance, please click here. If you are interested in learning more about PMS and PMCF studies, we also have a webinar on this topic.