Chemical Compliance Requirements for EU MDR and IVDR
Did you know that both the new Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) for the European Union (EU) include chemical compliance requirements in one of their subsections? In other words, to have your medical device CE marked for use in Europe, you may not only need to be aware of all the chemicals in your device, but you may need to also ensure they don’t include certain chemicals. If this is news to you, keep on reading—this is important! A note before we begin: I’ll mostly be discussing this in context of MDR to keep it simple, but IVDR is different, though similar—the differences are discussed lower down.
The chemical compliance portion of MDR is section 10.4. That section first details scope, so we’ll start there, too. The only medical devices that are in scope are devices that “are invasive and come into direct contact with the human body, (re)administer medicines, body liquids or other substances, including gases, to/from the body, or transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body.” Invasive is defined as “any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.” Generally speaking, that means only devices that are considered external communicating or implanted by 10993-1 fall within this scope.
MDDI, 26 April 2021