EU MDR Request for Manufacturers of Non-Medical Devices

Question: My company received a request for substance information in our products related to the European Union (EU) Medical Device Regulation (MDR) (2017/745). However, we don't produce medical equipment. Shouldn't we be out of scope? Are we required to provide this information?

Answer: If a customer is requesting EU MDR compliance information from you, they are likely using your products as components of medical devices they are producing. To meet their EU MDR obligations, then, your customer will need the information they are requesting from you.

Strictly speaking, you are not in scope of EU MDR, so EU MDR does not require you to provide information. However, it's a good business practice to provide the information your customer has requested. Doing so will give you a strong competitive advantage; a customer who needs EU MDR information to meet their compliance obligations will naturally prefer to do business with a supplier that can provide this information. Additionally, many sales or purchasing agreements have language requiring suppliers to provide information related to regulatory compliance, so you may be contractually obligated.

EU MDR is a complex regulation, but it's likely that all you will need to do is confirm or deny the presence of specific listed substances in your product(s).

Article is current as of 2020-11.

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