Certification according to EU Medical Devices Regulation

TÜV Rheinland, one of the world’s leading providers of testing and certification services, has granted Taiwanese medical device manufacturer GaleMed certification in accordance with the new EU Medical Devices Regulation (MDR). GaleMed produces respiratory care interface technology such as neonatal and prenatal ventilation. With the current certification, GaleMed and TÜV Rheinland are making an important contribution to the operational implementation of the MDR.

As part of EU reforms in recent years, the Medical Device Directive (MDD) has been upgraded to the Medical Device Regulation (MDR), which significantly increases the requirements for safety, performance, clinical evaluation, and life cycle of medical devices. As a result, manufacturers and distributors must comply with stricter requirements in terms of standards, quality, and market surveillance.

Recently, manufacturers and importers, as well as physicians, have increasingly pointed out the difficulties in implementing the new requirements and warned of possible shortages of medical devices, especially in the field of pediatrics. Earlier this year, the European Commission held out the prospect of extending the transition periods.

The European Union (EU) is the second largest medical market in the world and imports a large proportion of its medical products from China and Taiwan. In Germany, for example, the share for certain products such as respiratory masks is up to 90%, according to the Kiel Institute for the World Economy (IfW).