GAP analysis IVDD to IVDR

Purpose and goal

The purpose of the project is to carry out a GAP analysis of a medical device to identify any deficiencies in documentation and clinical evidence in relation to the IVDR. The goal is to develop a clear plan for further alignment with the regulation and to strengthen internal competence in regulatory requirements.

Expected effects and result

The project is expected to result in a completed GAP analysis of a medical device, focusing on documentation and clinical evidence in relation to IVDR requirements. The outcome includes a concrete action plan for continued adaptation and improved in-house capacity to meet future regulatory demands within the EU.

Planned approach and implementation

The project will begin with a kickoff meeting to define scope, objectives and responsibilities. A structured review of relevant documentation and clinical data will then be carried out in relation to IVDR requirements. The work is performed by external experts in close collaboration with internal staff, and will conclude with a summary report and action plan.