Conference Description:

The medical device regulation EU MDR 745/2017 in the European Union has a lot of requirements. This regulation is also stronger connected to the EN ISO 13485:2021. The first key for the understanding and the implementation of the changes is the knowledge about the relationship between the EN ISO 13485:2021 and the EU MDR 2017/745. The second key is to understand, which parts of the EU MDR 2017/745 are not covered by the EN ISO 13485:2021. These not covered paragraphs and requirements must be additional implemented into the quality management system.