Quality & regulatory compliance
Etac’s main focus is to provide safe products with high and consistent quality. The products are designed and manufactured according to state-of-the-art standards and principles for best practice. All our medical devices are CE marked and registered at relevant authorities in compliance with applicable legislations & directives.
We systematically evaluate our services for improved quality, functionality and performance in compliance with regulatory requirements to maintain product safety and efficiency throughout the complete lifecycle.
MDR
EU Medical Device Regulation
Etac is in compliance with the new European Medical Device Regulation EU 2017/745 (MDR) that became effective on May 26, 2021. The new MDR Regulation replaced the former MDD Directive, and the transition has been smooth as Etac already was compliant with MDD and works proactively with compliance.
Being in compliance with MDR once again confirms that Etac products are safe to use and in an excellent quality to the benefit of patients, users and our customers.