Question: I recently received a request for information under the European Union (EU) Medical Device Regulation (MDR). How is this different from similar requests for hazardous substance data? If I’ve already responded to requests under the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, why do I have to respond to EU MDR requests?
Answer: REACH and the EU MDR are two different regulations. They have different aims, and the requirements are different. Under EU REACH, substance data must be collected from suppliers and provided to customers when a Substance of Very High Concern (SVHC) is present over the allowed threshold. The EU MDR lists far more substances with regulatory requirements than EU REACH, so compliance with one does not indicate compliance with the other. Meanwhile, the EU MDR has product labeling requirements exclusive to the regulation, and an obligation to include additional substance information for the customer, which is not required under REACH.
Content is current as of 2020-01-24.