GAP analysis IVDD to IVDR

Important results from the project

The project provided a clear decision basis for proceeding with IVDR certification of DiviTum® TKa. The goal of identifying gaps in the technical documentation and clinical evidence was achieved. The work also strengthened internal competence and provided valuable input for improving our existing quality and regulatory processes also related to IVDR compliance during the current transition period.

Expected long term effects

In the long term, the project is expected to support a more efficient and structured path toward IVDR certification of DiviTum® TKa. It strengthens the company’s ability to meet regulatory requirements and manage future changes in legislation. The project has also contributed to increased internal competence and improved processes related to IVDR, which will benefit the continued commercialization of our current product.

Approach and implementation

The project was carried out as planned, with the objective to identify gaps between existing documentation and IVDR requirements. The work began with a joint kickoff meeting and continued with mapping of relevant materials, interviews, and ongoing follow-ups. Collaboration with external experts worked well and provided valuable insights. The selected activities were appropriate, the setup worked as intended, and the project was completed within the planned timeframe.