Tuttlingen - The EU-MDR confronts the medical technology industry with the same questions - to which answers can be found by working together: for example with joint clinical literature evaluations, the preparation of which was moderated by MedicalMountains GmbH as part of the MDR & IVDR Soforthilfe BW. Participating companies report on their first experiences with the results.
Thomas Butsch, Managing Director of HEBUmedical GmbH in Tuttlingen, is relieved and proud at the same time. Its complete range of reusable surgical instruments has recently been certified according to EU-MDR. We are talking about around 9,000 products or more than 50 technical files - according to the notified body involved, the Tuttlingen-based company was a pioneer in Germany on this scale. Thomas Butsch and his team face a Herculean task, but the support they received should not be underestimated. "The collaborative clinical literature reviews have been very helpful to us," says Thomas Butsch. "They are of very high quality and fit seamlessly into the rest of the documentation." This saved time and money and gained security: "You don't have to do everything alone and you don't always have to wander into the distance. Good help is closer than you think,” says Thomas Butsch.
Statements like these are valuable for Marena Hauser. She takes care of the joint projects at MedicalMountains GmbH. As part of the MDR & IVDR Soforthilfe BW, MedicalMountains GmbH moderated the creation of joint literature evaluations for more than 25 product groups. As with the medical devices themselves, “post-market surveillance” plays a special role in a figurative sense; the question of how the documents perform in practice. "The offers are intended to create pragmatic relief," reminds Marena Hauser, "and the positive feedback shows that this has been successful."
Especially when support offers are interlinked, as is the case with endox Feinwerktechnik GmbH from Dettingen an der Erms. "In the past, literature research was carried out with external consultants, we didn't have the capacity and competence in-house," reports Thomas Schobert. Nevertheless, this was very time-consuming and costly, since a lot of input had to be supplied and proofread. Through its passive membership in the ExpertTable "The practical implementation of the EU-MDR", the company received, among other things, templates for the clinical evaluation - which it was able to carry out itself. "The only catch," says Thomas Schobert, "was the literature research." After the joint evaluation of the "Fishing Instruments" product group was subsequently purchased, "we were thrilled with the scope. Which is what prompted us to join the guidewire consortium and stimulate further research that will be useful to us.”
The measure "product group-specific joint projects" of the MDR emergency aid program BW coordinated by the state company BIOPRO Baden-Württemberg is slowly being phased out; MedicalMountains GmbH is in the process of forming consortia for joint literature evaluations for the last time. However, the documents that have already been completed can still be purchased - even by medical technology companies that are not based in Baden-Württemberg. "On the one hand, it reflects the idea of sustainability," says Marena Hauser, "on the other hand, the conviction that Germany as a whole should be strengthened as a medtech location." This is also an expression of a new sense of community - that the future lies in cooperation.
An overview of the clinical literature evaluations that have been prepared can be viewed under this link .
