Question: What’s the difference between the EU MDR and the In Vitro Diagnostic Regulation (IVDR)? How do they affect each other?
Answer: The EU MDR and IVDR are different regulations with different thresholds and substance lists that are applied to different product types. While some confusion arises from EU MDR’s applicability to certain diagnostic devices, these separate regulations can be thought of as two sides of the same coin.
EU MDR applies to medical devices that come into direct contact with humans. It covers everything from bandages and catheters to implants and colored contact lenses. Some diagnostic and monitoring devices are also within scope.
In contrast to the EU MDR, the IVDR covers diagnostic and monitoring devices that may attach to a person, but are specifically used for monitoring human functions. A heart rate monitor, for example, would likely be in scope of the IVDR. The IVDR has a longer implementation period and affects a smaller product range (the EU MDR affects around 500,000 devices, while the IVDR affects approximately 50,000).
Article current as of 2019-08-02.