Premarket Innovators And SMEs (Part 1): How Many Will Survive EU MDR?
How delays in EU MDR compliance now threaten the lifeblood of the medtech industry
The EU Medical Device Regulation threatens the viability of many premarket innovators and SMEs in the UK, and across Europe. Eithne Lee, of ISO Life Sciences global consultancy, explains how the new requirements come as a shock for many small companies, how many are ill-prepared and how the cost of compliance relative to turnover may be too high. This is part one of a two-part article.
You may also be interested in...
In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.
At the LSX World Congress in London, leaders from Medtronic, Johnson & Johnson and Olympus discussed the evolving medtech mergers and acquisitions landscape, the big opportunity in robotic surgery and the impacts on innovation of the forthcoming EU Medical Device Regulation.
With fewer than a hundred days left before the EU Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss in this week's podcast growing concerns by medtech industry members that they may not be ready in time to comply with the regulations and may inadvertently run afoul of them.