Publication Date: March 15, 2017 (Originally published in Qmed.com.)
Contributing authors: Beate Klumpp, Principal MRS, Biosafety & Validation, NAMSA

To promote health and safety while supporting medical device innovation, the European Commission, Council, and Parliament are transforming the Medical Device Directives (MDD; Council Directive 90/385/EEC for active implantable medical devices and Council Directive 93/42/EEC for medical devices) into one set of regulations. These European Medical Device Regulations (MDRs) are intended to harmonize the rules for marketing medical devices and their accessories in the European Union.