Brussels/Munich (dpa/lby) – Bavaria’s Health Minister Klaus Holetschek (CSU) is committed to more practicality in the new EU Medical Devices Regulation. Small manufacturers of niche products, for example for children or for the treatment of rare diseases, feared a certification backlog, said Holetschek after a visit to Brussels on Tuesday. The companies complained, among other things, that there were too few certification bodies and other bureaucratic hurdles.
Some companies have already announced that they no longer want to bring innovative products onto the market. What is needed is an exemption for niche products and a solution for existing products that, due to capacity bottlenecks, cannot make the transition to the new directive by 2024 as previously required.
