Aap Implantate AG Achieves Significant MDR Certification Milestone

aap Implantate AG has successfully transitioned from the MDD (Medical Device Directive 93/42/EEC) to the MDR (Medical Device Regulation EU 2017/745). The company received the MDR certification for its quality system after a successful audit in September 2024. Class IIa medical devices have already gained MDR certification, with additional classes such as plates and screws soon to follow.

This certification is vital for marketing medical devices in the EU beyond the 2028 transition period. It is also essential for launching new products in the EU. aap Implantate AG plans to expand its product range and focus on new product development, enhancing its market presence.