– The three-year transition period for the new European Medical Device Regulation is drawing to a close. Starting in May 2020, manufacturers of medical devices will face significant changes in approval processes. Both new and previously approved devices will be subject at this point to the EU-wide Medical Device Regulation (MDR).
Raumedic is already well-versed in the tougher requirements of the new regulation. Reiner Thiem, the Head of the Regulatory Affairs Department at the Helmbrechts-based medical technology company, said: “We have intensively worked over the last three years to gain an understanding of the new regulatory landscape.” As part of this effort, Raumedic has constantly adapted its own processes and the materials it uses to the requirements of the new MDR as well as satisfactorily validated and qualified them.
The company has also been providing targeted help to its customers so that they will also be able to operate in the new legal environment. “When a manufacturer orders components from us and wants to have the final product registered in accordance with the new regulations, we actively provide our help,” Thiem said. “We can make sure that the relevant information and documents for authorization, as regulated in our joint agreement, are provided.” About the new EU Medical Device Regulation
The European Parliament passed the new Medical Device Regulation (EU) 2017/745 in 2017. The regulation will take effect on May 26, 2020, following a three-year transition period. The new regulation, or MDR, will replace the current Directive on Medical Devices (93/42/EEC) from 1993 and the Directive on Active Implantable Medical Devices (90/385/EEC) from 1990.
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