For many medical device manufacturers, R&D occurs under perfect lab and controlled clinical conditions. When devices leave that environment and enter the wild, manufacturers face a host of “unknown unknowns”—risks and user behaviors that pre-market testing never revealed. This can create a mountain of administrative work to comply with the latest medtech regulations.
Recently, Tom Patten, IVDR international manager at GMED, and Elizabeth Gfoeller, corporate director of regulatory affairs at MED-EL, discussed how medtechs should rethink these regulations and the associated post-market surveillance (PMS). By taking three key steps, medtechs can shift this work into an opportunity for strategic advancement rather than a regulatory checkbox:
This proactive approach can transform the relationship between medtech manufacturers and regulatory bodies, shortening core processes and product re-certification timelines to accelerate global market access. This is particularly important as international reliance (e.g. the UK accepting the CE-mark) is increasingly under discussion.
The journey of a medical device does not end with a certification; in fact, that is just the beginning of what Gfoeller described as the “never ending story”. While risk management files cover the “known knowns” and “known unknowns,” the real world inevitably introduces “unknown unknowns”. To capture these unknown variables, a post-market surveillance system (PMSS) must be active, systematic, and continuous.
Manufacturers are legally required to actively gather post-market experience data to update their technical documentation, which is then used for benefit-risk determinations, risk management files, design information, and instructions for use so devices remain safe and effective.
A common pitfall for manufacturers is designing a PMSS solely to appease a specific regulator or Notified Body. Instead, Patten stressed that companies should build a system that works for their product needs across all markets, rather than just catering to MDR or IVDR requirements.
From a regulator’s perspective, how a device was designed twenty years ago is important, but how it’s performing in patients today builds an incredibly strong picture. This is one reason why presenting solid data in a clear manner from a high functioning PMSS is so important. To succeed during an audit, manufacturers must ensure complete traceability.
If a customer complaint trend spikes, it should logically trigger a cascade of evaluated actions: Does the risk file need updating? Is a field action or design change required? Are there impacts on labeling or other devices in the portfolio? Patten noted that regulations will require these actions to be traceable throughout the Quality Management System (QMS) and possibly feed into the technical file.
When a manufacturer presents robust, real-world evidence, it can strengthen data already present in the technical file and give the auditor a strong sense of how that device is performing right now.
Historically, medical device data has been siloed across different departments with clinical, regulatory, and quality teams often working independently. Pulling this data together can feel like a “PMS mess,” but forcing cross-functional collaboration is where the true value lies.
Gfoeller explained that bringing patient-facing teams, clinical experts, and regulatory personnel into the same room to review PMS data is incredibly valuable. While a regulatory professional might simply check if the data complies with certain requirements, a patient-facing expert might look at the same data and identify a usability issue that requires a software release or design iteration.
By analyzing these trends, medtech organizations can identify risks and events that are less severe but may appear in high volumes, or could be indicative of broader efficacy and safety concerns.
A well-optimized PMSS extends far beyond European compliance. As MED-EL oversees a global function, they recognize that regulatory bodies worldwide—including those in Canada, Australia, and China—are increasingly scrutinizing these reports. If a manufacturer takes the time to define measurable safety and performance outcome parameters pre-market, they can systematically monitor them post-market.
MED-EL learned early on that some pre-market metrics were simply not measurable once the device was in the wild. Refining these metrics creates a clear-sighted strategy that yields high-quality data.
Furthermore, the MDR does not mandate that clinical data must exclusively come from European citizens. If a device is launched in the US or China first, manufacturers can leverage that international data for their EU submissions, provided the patient cohorts and intended uses are similar.
Ultimately, both the manufacturer and the Notified Body want the same thing: to introduce and keep safe, effective products on the market. By taking ownership of the device’s life story, breaking down internal silos, and actively monitoring the “unknown unknowns,” manufacturers can transform post-market surveillance from a dreaded compliance exercise into a powerful engine for product improvement and global growth.
—
For more insights on postmarket surveillance, download the Veeva MedTech Postmarket Quality Benchmark.