The questions covered by this document aim to guide economic operators carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) of the Regulations concerning relabelling and repackaging of devices.

It is not intended to address the quality management system and related certification activities, which is provided in MDCG 2021-232  , nor elaborate on Article 16(1) of the Regulations.

It is also noted that Article 16(2), (3) and (4) of the Regulations do not apply to operators subcontracted by the manufacturer (that may also qualify as importers or distributors), who also carry out relabelling and/or repackaging activities on behalf and under the control of the manufacturer.


MDCG 2021-26. Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

October 2021