Perpedes is a manufacturer of foot orthoses since 1927. Since an update to MDD 93/42 was required, the requirements of MDD 2017/745 were quite demanding and resulted in the retirement of some legacy devices. The goal of uniting the European market under one law was clearly missed. The protection of the market vs. unsafe medical products failed, there is no noticable monitoring of online platforms. Software products are treated with higher risk ratings while the FDA deregulates them based on studies that found lower risk. We refer to the statement of the Eurocom Association, see appendix.
We are pleased with this initiative and would like to expand your view to other groups of medical devices: We produce shoes to be worn with orthosis. At the moment we have 78 models in up to 3 width and in sizes ranging from size 20-48 (4K-12 UK) depending on the model. Because we sell them also by piece, 1 model can have more than 270 varieties with identical clinical use. It would make a huge difference for us, if we would have to register more than 14.000 devices instead of 78 Master UDI-DI. This also applies to orthopedic insoles and many other products in this field.