MGA Medical picks up speed with working group results
Working group Approval: MDR finally easy to understand
In the light of the meanwhile postponed “go-live” of the MDR by one year to 26 May 2021, we were granted additional time to gain deeper insight into the regulations and to render the definitions specific to Annex VIII classification rules in a more simple format. Further results of our elaboration will be published exclusively for our members in the members’ corner online in the coming weeks.
Working group Materials: During the last working group virtual session on 19 May 2020, Özlem Weiß introduced the different material classes (polymers, metals, ceramics/glass, others), their desired properties and the definition and differentiation of the terms “biocompatible” and “medical grade” to the group. The focus was clearly on ceramics. Raichard Gaignon, CEO of 3D Ceram, gave an exciting presentation on ceramics in clinical applications. The next meeting focusing on polymers will take place on 23 June 2020.