The EU MDR (Medical Device Regulation) tends to follow the approach of the US FDA (Food and Drug Administration). In the current situation, it tightens the existing regulatory framework for medical devices in Europe in a way that is unacceptable to many market participants.
Compliance and the growth of the medical industry, does it work together? This question is highly relevant because the growth in the medical device industry is significant. And also, this will continue to be the case for the foreseeable future.
The European Commission has published an update of the list of European harmonised standards under the Medical Devices Directive (93/42/EC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostics Directive 98/79/EC.