The EU Medical Device Regulation 2017/745 came into force on May 25, 2017, and it will replace the two directives, 93/42/EEC (Medical Devices Directive) and 90/385 (Active Implantable Medical Devices Directive), on May 26, 2020.
One of the changes introduced by the new regulation is a requirement that manufacturers implement a quality management system and add a person to their team who is in charge of regulatory compliance.
ISO 13485 is an internationally recognized, quality management system standard for the medical device industry, which ensures that the manufactured medical devices are safe for their intended purpose.
Certification based on ISO 13485 facilitates the implementation of requirements that are regularly applicable to medical devices and related services.
Learn more here.
