Pilot study for MDR/CE mark

Important results from the project

The goal of the project was to start the process for compliance according to the MDR and create knowledge in our organization about the eligibility requirements that are set for a CE marking. The project proceeded according to plan and provided good insights and basis for future strategic decisions.

Expected long term effects

The project defined intended use of the service as well as qualification and classification within compliance for MDR. The project delivered a complete GSPR checklist with identified activities, a started summary of technical documentation for MDR/CE certification and project plan for future work. The project has provided a greatly increased competence in MDR/CE marking in the organization.

Approach and implementation

Compilation of information about the product, processes and organization before start-up Start-up including meeting, time for introduction Qualification, classification and plan for activities. Define intended use and intended users for the product In-depth analysis and produces the necessary data to start implementation/creation of the technical documentation required for CE marking. First version of Technical Documentation (TD) Summary and a GSPR checklist Project plan for a CE marking project