Question: My company sells antimicrobial wound dressings. We know the dressings need to comply with the EU Medical Device Regulation (MDR), but we aren’t sure whether their packaging materials must also be compliant. The dressings are sealed in a sterile envelope, then packaged in a paperboard carton along with printed product literature. These cartons are packed in larger cardboard boxes or cases. Does any of this packaging material need to comply with the EU MDR?
Answer: In general, the EU MDR applies only to medical devices themselves rather than packaging or labels. However, the definition of medical devices subject to the substance requirements, per EU MDR Annex I, Section 10.4.1, includes 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.”
The sterile envelopes in which the dressings are originally sealed likely fall into the “transport or store” aspect of this definition. Both the dressings and their immediate sterile envelopes, then, would be considered medical devices and would need to comply with the EU MDR. The other layers of packaging likely would not.
Article is current as of 2020-06-26.