I am a manufacturer of a Class I medical device. Do I need a certified quality management system? The Medical Devices Regulation (MDR) will be the sole legislation in force as of 26 May 2021. According to the MDR, all manufacturers are required by law to introduce and document a quality management system for the processes required under the Regulation. BEO BERLIN can draft the required documents and templates for you in compliance with the new statutory requirements.
This month, DIN EN ISO 15223-1:2020-04: Medical devices (draft) was published