MDR certificate for BOWA MEDICAL

BOWA MEDICAL received MDR certification in August 2020

The Medical Device Regulation (MDR) 2017/745 EU represents a major challenge for medical technology companies.

BOWA MEDICAL was one of the first medical technology companies and manufacturers of energy-based surgical products in the European Union to achieve this certification, successfully completing all necessary audits by March 2020. In order to meet the diverse requirements of the MDR, BOWA MEDICAL’s Quality Management team restructured numerous processes over an intensive two-year preparation period and completely revised the documentation of all products (involving over 1,000 items). The restructuring required close cooperation between BOWA MEDICAL and the notified body TÜV Süd (CE0123), as well as with many long-standing suppliers and service providers. BOWA MEDICAL has successfully met all of the stringent requirements regarding clinical evaluation and investigation, new classification rules and conformity assessment procedures, new registration procedures for products (EUDAMED/UDI), product traceability as well as stricter documentation and safekeeping requirements, etc. The hard work has paid off: In August 2020, BOWA was awarded the coveted MDR certificate.