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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.
This rule applies to all 27 European Union member states, as well as Iceland, Liechtenstein, Norway, and Switzerland (the European Free Trade Association States). If you intend to market your in vitro diagnostics, software, or accessories in these countries, you must have them certified by the date of application (i.e., May 26, 2022). If your company isn’t based in the EU, you’ll need to find an authorized representative to assist with the conformity process.
The MDR applies to medical devices that come into direct contact with humans—from bandages and catheters to implants and colored contact lenses. Some diagnostic and monitoring equipment fall under this category as well.
The IVDR covers diagnostic and monitoring devices that may attach to a person but are specifically used to monitor human functions. A heart rate monitor is one example of a device covered by the IVDR. The IVDR affects a smaller number of devices (approximately 50,000) as compared to the MDR (approximately 500,000), and it has a longer implementation period.
Learn the new rules introduced to the In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure compliance.
