Medical Device Safety Monitoring & Regulatory Reporting
Devices Come Under New Post-Market Scrutiny

David Gwyn
Global Solution Architect
AMPLEXOR Life Sciences


he pharmaceutical industry has long had to comply with the kinds of strict reporting standards and ongoing monitoring that will soon apply to medical device manufacturers. So what best practices have emerged that device manufacturers might now borrow from?

Medical device monitoring and reporting is about to experience a big shake-up. The PIP breast implant scandal is just one of a series of high-profile cases which have led to calls for closer post-market tracking and reporting rigor. It all feels very reminiscent of measures first applied to the human pharmaceutical industry some 14 years ago–as authorities around the world sought to enforce stricter safety controls.

Since then, drugs companies have come a long way, culminating in their current preparations for ISO IDMP requirements. So what can device manufacturers learn from their journey?

Until now, the medical device sector has been largely exempt from after-sale monitoring controls; quality/safety considerations have been largely confined to the manufacturing shop floor. But this will change in the run-up to the European Commission’s new Medical Device Regulation (MDR), applicable from May 2020, and the equivalent In Vitro Diagnostic Medical Device Regulation (IVDR), due for introduction in May 2022. Once the new regulations apply, device manufacturers will have to formally monitor the long-term safety of their products, and provide evidence of their follow-up findings in periodic safety update reports.

Bringing the Outside In

First, companies will need a means of capturing post-market safety data. MDR demands a detailed summary of safety and clinical performance information, which must be updated and reported at regular intervals with post-market clinic follow-up findings–a combination of formal studies, incoming feedback from patients and GPs, and potentially commentary captured via public online patient forums and social media platforms.

This rigorous post-market surveillance obligation will apply to every category of medical device, creating a lot of work for manufacturers. Failure to comply could lead to multi-million-dollar fines, products being taken off the market, and lasting reputational damage.

The new demands are likely to extend beyond Europe before too long, too. In the US, more than 1.7 million injuries and almost 83,000 deaths may have been linked to medical devices, based on reports to the FDA over a ten-year period. Meanwhile the International Medical Device Regulators Forum (IMDRF) has taken a keen interest in MDR and IVDR, which could result in countries in Asia and South as well as North America adopting their own variations of the requirements in the coming years.

Lessons from the Frontline

So what lessons can medical device manufacturers learn from the experiences of pharmaceutical companies, to help them meet their obligations in the most efficient and effective way?

The first recommendation is not to regard compliance as a single event that can be planned for with a finite, all-encompassing project or definitive software solution. As pharmaceutical organizations have found, the global regulatory climate is continuously evolving, so there is no definitive single answer to deliver compliance. Many pharmaceutical companies ended up with twenty or more different systems from different vendors by taking a best-of-breed systems approach. When they subsequently ran into integration and data-exchange problems, they then largely had to fall back on manual processes and spreadsheets for pulling together all of the required information.

Over time, pharmaceutical firms have recognized the value of establishing an end-to-end information management capability that can be adapted to a range of different needs. The ideal is to get to a single, complete, master set of data about products and their evolving status right across the product lifecycle, which can be applied as needed for each different use case.

This approach offers multiple advantages, not least the reduction of repetitive data re-entry or document creation, and the opportunity to automate preliminary information checking and content building processes. It has enabled pharmaceutical organizations to do away with huge teams of temporary staff previously charged with reviewing and editing regulatory documents, because it’s now much easier to reliably automate much of the work.

Thinking Outside the Box

Exploring the possibility of wider efficiency gains will also serve medical device manufacturers well as they are called on to provide better information directly to patients. That’s in addition to the immediate benefits of being able to look up a product’s market and regulatory status in just a couple of clicks.

With the clock ticking on MDR, however, there is little time to lose, especially if companies want to maximize the business benefits of their regulatory compliance measures. As many pharmaceutical firms learned the hard way, leaving compliance investments until too late in the day can push up costs, limit big-picture thinking, and curb agility.