Technical Documentation for Medical Devices
As requested under the previous directives, Technical Documentation must be available and kept up to date for all Medical Devices placed on the market in the EU.
If the manufacturer is located outside the European Union, this documentation must now be available from the European Representative appointed by the manufacturer.
The number of General Safety and Performance Requirements which replace the Essential Requirements has reached 220 points to be reviewed and robust risk management must be put in place and regularly reviewed.
New requirements have arisen, for example with regard to substances Carcinogens, Mutagens, toxic for Reproduction (CMR) and endocrine disruptors.
The information to be provided by the manufacturer in its user manual and on the labels is now very regulated. But as expected, clinical requirements have changed the most.