MedTech Forum 2022: How Regulatory Complexity Is Crushing The EU
Executive Summary
Is it time to reflect on how the EU can take measures to escape a situation where regulation threatens innovation, product availability and product costs and to stop this trajectory of ever increasing the regulatory bar?
You may also be interested in...
EMA Takes Over Permanent Secretariat For Medical Device And IVD Expert Panels
Despite resistance from the medtech industry, the European Medicines Agency now has a key role in the medical device and IVD expert panels, which have only recently been set up.
EU’s Risk Management Standard Officially Recognized In Context Of The IVDR
Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is that it is arguably one of the most needed standards by the IVD industry after the medtech quality management standard, ISO 13485.
Device/Drug Borderline: Gray Areas Remain Despite New EU Guidance
The regulation of products on the drug/device borderline has always been complex. New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the manufacturer.