As medical devices become more critical to patient outcomes, regulators around the world are steadily increasing controls around the manufacturing, distribution and monitoring of devices. Drawing on new research, Peter Muller and Mike Baird of Schlafender Hase assess how well Class 2 and 3 medical device manufacturers in Europe and the US are adapting.

Technology innovation, combined with pressures on health services to treat patients more effectively, efficiently and conveniently, has led to sharp growth in advanced medical devices and their prominence within care pathways. Globally, the medical devices market is projected to grow from $542.21 billion in 2024 to $886.80 billion by 2032, while medical device sector representatives now account for 50–70% of the attendees at meetings of RAPS, the Regulatory Affairs Professionals Society (just three years ago, delegates were mostly from pharma).

As devices become more critical to patient outcomes, and as safety-related scrutiny is intensified, regulators around the world are steadily increasing their expectations and controls around the manufacturing, distribution and monitoring of devices. The aim is to bring developers and suppliers of these products more closely into line with the requirements around pharmaceutical goods.

This has implications right across the medical device industry internationally, spanning a potential need for new systems and processes, attention to the way these are linked and tracked, and the distribution of appropriate skills across the workforce. A new international benchmark report has set out to determine how well manufacturers and their regional or national partners are adapting to the rising regulatory demands.

The 2024 study, conducted with 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), highlights the number of challenges currently vying for attention and investment and assesses device companies’ current state of regulatory readiness.