The April 26, 2021, edition of MD+DI features Chemical Compliance Requirements for EU MDR and IVDR written by Nigel Syrotuck, StarFish Medical Mechanical Engineering Team Lead.
Sub headed Is your medical device or diagnostic in compliance with this small, but essential, sub-section? Syrotuck uses the article to educate readers that in order “to have a 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.”
Syrotuck discusses this point in context of MDR to keep it simple, but cautions, “IVDR is different, though similar—the differences are discussed lower down.”
He concludes, “Overall, it’s important to note that, succinctly put, the scope of MDR is limited to directly or indirectly invasive devices only, and for IVDR there is no specific threshold for chemical contents. Also note that whether or not your device falls in scope of the MDR directive doesn’t change whether or not it is in scope of other regulations or directives such as REACH. (REACH is completely separate except for the overlap of MDR using for the REACH list as a reference list). If your device is in scope, collecting materials information for your parts and parsing two lists with over 4000 chemicals between them is an endeavour worthy to dedicate some time to—it will not be trivial.”
Nigel Syrotuck is a StarFish Medical Team Lead Mechanical Engineer and frequent guest blogger for medical device media including MD+DI, Medical Product Outsourcing, and Medtech Intelligence. He works on projects big and small and blogs on everything in-between. He apparently has no tolerance for no tolerancing.