Medical technology manufacturer, Raumedic, explains how the company is preparing for the enforcement of EU Medical Device Regulations (MDRs).
The MDRs will come in to effect in all EU Member States from 26th May 2020. This legislation is relevant for all manufacturers who are selling medical devices within Europe.
Raumedic has been constantly adapting its processes and materials in order to suit the requirements of the new MDR, as well as satisfactorily validating and qualifying them. 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.”
The company has also been providing its customers with targeted help to ensure that they will also be able to operate when the EU MDR is enforced. Thiem commented: “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.
“We can make sure that the relevant information and documents for authorisation, as regulated in our joint agreement, are provided.”