Does the EU Medical Device Regulation (MDR) apply to labels that don’t come in direct contact with products, only the packaging?
According to the text of EU MDR Section 10.4.1, the regulation applies to devices, or those parts thereof or those materials used therein 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.
So under the terms of the EU MDR, unless a label comes into direct contact, it isn’t strictly in scope. However, to remain diligent, consider reporting the substances on a label, as it may in the future be required to be placed in a specific visible location, as part of the product approval process, whereby human contact may occur.
Labels on medical devices can also be affected by other regulations. For example, under (i) EU REACH, a label can be defined as an article, and is therefore subject to the regulation; (ii) EU RoHS, the label has to meet the requirements of RoHS if affixed to a product in scope that meets the definition of electrical and electronic equipment.
**Article contents valid as of 2019-03-18