What is IVDR 2017/746 Compliance?
IVDR 2017/746 Compliance Definition
In vitro diagnostic regulation (IVDR) 2017/746 is the latest set of regulations that govern the clinical investigation, production, and distribution of in vitro diagnostic medical devices in Europe. This regulation applies to any device that is intended to examine or monitor human function (e.g., blood grouping, COVID tests, glucose monitors, pregnancy tests). Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace. IVDR 2017/746 is scheduled to go into effect on May 26, 2022 and will replace the EU’s previous Medical Device Directive 98/79/EC on in vitro diagnostic medical devices.
Under the new regulation, manufacturers will need to provide more in-depth clinical data to demonstrate their safety and performance claims. In addition, medical devices will be classified based on the risk that they pose and the level of notified body oversight (i.e., Class A, B, C, or D). Devices that meet the requirements of the regulation will receive a CE Mark.
