Regulation

Regulation

Views on the rules and regulations that govern MedTech.

General Counsel and Director General Legal & Compliance, MedTech Europe
At first sight, EU policy on mergers and acquisitions might not need to concern patients and frontline healthcare workers too much. However, a subtle shift in...
Director Government and Regulatory Affairs, Cook Medical EMEA
The pandemic has changed many aspects of our lives. This is no different for those of us in the medtech space where we were pushed to rethink how we work. In...
Chief Executive Officer, MedTech Europe
Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal...
CEO - MedicalMountains GmbH
On 26 th of May 2021 the EU Medical Device Regulation (MDR) became fully applicable. It is a modern piece of legislation that strives to ’ establish a robust,...
CEO - QUNIQUE GmbH
After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A...