Premarket Innovators And SMEs (Part 2): Running Out Of Time In The EU MDR Race
In the medtech industry, who is most vulnerable in the run up to the EU MDR’s 26 May deadline?
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.
You may also be interested in...
Premarket Innovators And SMEs (Part 1): How Many Will Survive EU MDR?
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.
Is The Implementation Of The EU Medtech Regulatory Structure Entering A New Phase?
Three weeks have gone by now since the European Commission published a “latest update” on the medical device sector pages of its website. What does this mean for the sector?
How And Where Tougher Clinical Evaluation Measures Under EU MDR Cause Challenges
A first of its kind study examines how large compared with medium companies are coping with the EU’s strict clinical evidence requirements. The results show how it is the more stringent demands for high-risk devices that are leading to device removals as well as market launch outside the EU.