Technical documentation section:
2. Information to be supplied by the manufacturer
Section 2 of Annex II of the MDR requires manufacturers to include in the technical documentation a complete set of information that will be supplied with the device. This includes the labeling and the instructions for use, provided in the languages accepted in the EU Member States where the device is intended to be marketed.
Labeling
The technical documentation must contain all labels placed on the device and its packaging. This includes, where applicable, single unit packaging, sales packaging, and transport packaging if specific conditions of handling or storage are required. Labels must be presented in the languages required by each targeted Member State.
Instructions for use
A complete set of the instructions for use must also be included in the technical documentation. These instructions must be made available in the languages accepted in each Member State where the device is intended to be sold. The instructions should provide all necessary information for the safe and effective use of the device by the intended user.
Below, you will find links to information about the documents included in Section 1 of MDR-compliant technical documentation, covering key requirements for information to be supplied by the manufacturer.
