The Medical Device Regulation (MDR) 2017/745 EU represents a major challenge for medical technology companies. As one of the first medical technology companies and manufacturers of energy-based surgery products in the European Union, BOWA successfully completed all necessary audits by March 2020.

In order to meet the diverse requirements of the MDR, BOWA’s Quality Management restructured numerous processes over an intensive two-year preparation period, and completely revised the documentation of all products (with over 1,000 items). The restructuring required close cooperation between BOWA and the notified body TÜV Süd (CE0123), as well as with many long-standing suppliers and service providers. BOWA has successfully met all of the stringent requirements of clinical trials and evaluations, new classification rules and conformity assessment procedures, new registration procedures for products (EUDAMED/UDI), product traceability, as well as stricter documentation and safekeeping requirements and many more.

The hard work has paid off and in August 2020, BOWA received the coveted MDR certificate.

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