Please note the document structure updated by us in January 2020 for the submission of Technical Documentation under Directive 93/42/EEC (MDD) and (EU) 2017/745 (MDR) and the associated empty structure prepared by us in the form of a ZIP file.
Regulation (EU) 2017/745 (MDR) poses extensive requirements for the content and level of detail of a technical documentation.
We have transformed these requirements into a document structure which should also be used as the preferred format for submission under Directive 93/42 / EEC (MDD).
This format forms the basis for electronic transmission of technical documentation via mss - mdc secure space.
mss serves as a tool for the exchange of sensitive data between mdc as certifying body and mdc's customers.