Navigating the challenges and benefits of post-market clinical follow-up
Interview with Marcus Torr, PMCF / MDR Lead
Published in Medical Devices Zone
Post-market clinical follow-up (PMCF) is an essential aspect of medical device regulation, aimed at proactively ensuring the safety and performance of devices on the market. In this interview Marcus Torr provides a breakdown of this approach, including how it can improve patient safety as well as the challenges it poses for small to medium-sized enterprises.
Could you provide a brief explanation of post-market clinical follow-up (PMCF)?
PMCF is a big factor in medical device regulation. Previously, the old directive was a reactive process. If there were any issues with a device, be it safety or performance related, it was the responsibility of the physicians or clinicians to report those to manufacturers, the manufacturers would then decide what to do in response to those issues. It was very reactive instead of proactive process.
The Medical Device Regulation (MDR) came into force, with a key aim of pushing manufacturers towards being more proactive, and in turn improving the safety and performance of devices on the European market. Now, once a device is on the market, manufacturers have to continuously and proactively collect data, to assess the safety and performance of their device throughout its lifetime. There are many ways of doing that. For data collection, there are full blown clinical investigations and studies, registries, standard literature, data reviews, complaints handling and so on. PMCF surveys are a nice cost-effective approach for collecting PMCF data.
How might PMCF change the regulation of new devices?
The reason for Medical Device Regulation (MDR) and PMCF is to try and help improve the safety and performance of devices. The underlying reason for my role is to benefit patients. However, despite the benefits to patients, it makes it difficult for manufacturers. That applies to manufacturers of all sizes big and small. Small to medium enterprises with smaller portfolios or whose devices are less widely used are struggling because PMCF requires more resources, more time and more expenditure needed to comply with these requirements.
Unfortunately, that means some devices must be taken off the market because the cost associated with MDR compliance and PMCF data collection isn’t worth keeping the device in the market. If a new device comes onto market, it’s now important for manufacturers to consider whether they will be able to put forward those costs and resources to comply with PMCF and the MDR. Because of this, manufacturers should be strategic to bring new products to market. Unfortunately, this means they’re sometimes launching in other markets outside of Europe because it’s easier to get on the market there, before coming to Europe. Though the rationale behind introducing the MDR and PMCF had patient safety as its priority and was well-intended, it’s possible that it could be stifling innovation or reducing the number of products on the market.
How will PMCF impact existing devices that are already well established?
PMCF is a great way of collecting data on legacy devices where data already exists and is more widely available. In this case, PMCF surveys could be a good option to collect data as it’s a cost-effective and quick option. PMCF encourages manufacturers, even if they’ve already got data on their devices, to continuously collect more. There is a greater requirement now for manufacturers to go out and collect PMCF data but the good news for well-established existing devices is there are easier and cheaper ways to be able to continuously collect data throughout a device’s lifetime.