Every required document.
Every operator. One source of truth.

MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.

The software platform is designed to support the contracted Economic Operator, it can be used by the Legal Manufacturer to manage the downstream Economic Operators, such as the Authorised Representative, the Importer and the Distributor. Similarly, the software platform can be used to manage the upstream Economic Operators, such as an Authorised Representative or Distributor managing multiple Legal Manufacturers, and their provided Technical Documentation and or their Accompanying Documentation, such as the IFU and Product Label per Basic UDI and each consequent UDI-DI.

It is developed to ensure that the technical documentation and accompanying documentation of the Legal Manufacturers is available to each Economic Operator in the medical device distribution chain. In the event of Post-Market incidents, the Economic Operators have continuous access to the latest version of the Documentation, and the system will facilitate Vigilance reporting to regulatory databases, such as EUDAMED through the IMDRF coding systems.

The software platform is designed to support an effortless upload of technical documentation and accompanying documents to facilitate quick and easy sharing across Economic Operators. The technical documentation and accompanying documents are split into separate sections to ensure that each Economic Operator only gains access to those sections relevant to their duties, for example, the Distributor will only gain access to the Labeling materials relevant to their region.

The software platform is designed to automate registration into regulatory databases such as EUDAMED. Once all data for EUDAMED is present, it can be pushed through the EUDAMED API towards EUDAMED, any new UDI-DI added to the system can simply upload the new UDI-DI into EUDAMED, and into future supported databases, such as GUDID and SWISSDAMED.

If, for any need, access to documentation needs to be cancelled, the user can withdraw access. Note that there are legal obligations for Economic Operators for continued access, even when a contract with a Legal Manufacturer has been cancelled. As such information shared prior to end of contract date will continue to be accessible for the relevant Economic Operators.