Europe – The Future of Europe’s Medical Technology Regulations

MedTech Europe’s vision for an efficient, innovation-focused, and wellgoverned regulatory framework

MedTech Europe and its members fully support the objectives of the medical technology regulations, In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical Devices Regulation 2017/745/EU (MDR): to establish a “robust, transparent, predictable and sustainable regulatory framework for [in vitro diagnostic] medical devices which ensures a high level of safety and health whilst supporting innovation”.1
However, after almost six and a half years of implementation, the IVDR and MDR have still not fully achieved these objectives…