The new medical devices regulations (MDR) and in-vitro diagnostics regulations (IVDR) represent a long-awaited strengthening of the existing regulatory system for medical devices in Europe, however over the next two years, compliance with it represents a real challenge for medical device companies. 

In advance of the Medical Devices Regulations becoming fully applicable on 26 May 2021, our team of regulatory experts have created a guide discussing the key changes from the ‘old’ system of classification to the new,  the impact of the Regulations on existing certified devices and highlights key aspects of the Regulation which Medical Device Companies should be familiar with as they face into this new regulatory regime. 

Click here or on the image below to download our full briefing.

Contributed by  Laura Casey