MDR-FIT - Medical Device Regulation MDR 2017/745 - Realization of In-House Approval

Project: Research project

Project Details


The project includes an analysis phase on the procedure for in-house manufactured medical devices at three different clinics. The results of existing preliminary research on affected products are to be analyzed in order to achieve a correct procedure according to MDR 2017/745 and MPG 2021. The first project report includes the analysis about the current "In-House" manufacturing process and the procedure to create the technical documentation of the products. This is to be carried out per clinic with reference to details of the products concerned. In the subsequent project phase, an individual concept assessment is carried out for the three clinics based on three products selected in the analysis phase. This includes the classification of individual products, the evaluation of measures already taken for this products, the compilation of the necessary technical documentation, the evaluation of the implemented software development process and the evaluation of the implementation of a quality management system.
Effective start/end date16/09/2231/12/23


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