Manufacturers have a narrowing window of opportunity during which to find pragmatic ways for gathering post-market data to support continued use of products under the Medical Device Regulation (MDR), according to experts who spoke at the Euro Convergence 2020 virtual meeting.
The outgoing Medical Device Directive (MDD) contains scant information on post-market surveillance (PMS) and post-market clinical follow-up (PMCF). MDD contains two uses of the term PMS, creating considerable uncertainty about what is expected of manufacturers. MDR, which uses the term PMS 66 times, is intended to reduce uncertainty but is creating new challenges in the process.
“There’s going to be a lot more effort required,” said Adrian Keene, director of EMEA consulting services at NAMSA, a private firm. “We know that the claims for legacy devices all need to be supported, so we’re going to utilize the article 120 grace period and try and find pragmatic – and I think it’s very important they are pragmatic – PMCF approaches to gather relevant data.”
Daniela Karrer, vice president of operations and clinical affairs at Donawa Lifescience, shared a closer look at the approaches available to companies. In some cases, companies may need to run randomized clinical trials, the highest level of evidence in the MDR hierarchy. However, the cost and complexity of such trials means companies may want to find other ways to generate evidence to support their devices. Manufacturers of legacy devices may be able use existing data…