Once again, we have been asked by friends in the assistive technology industry to share our knowledge and experiences related to implementing MDR, Medical Device Regulation, in our organisation. This time it is DATEurope who approached us, asking if we can present our learnings and successes that we experienced along our way to become a MDR certified company at their upcoming event end of March.
Within Abilia, the whole organisation has been involved to ensure we understand and meet the requirements of MDR. At this event, Anna Wik, Manager Quality, Sustainability and Regulatory affairs, and Anna Sahlholm, Medical Science Liaison and Portfolio Manager, will be representing Abilia.
At the knowledge sharing event, open exclusively for DATEurope members, Anna and Anna will hold two digital sessions about MDR for class 1 products, in theory and in practice. The two seminars will give an overview of the legislation, the different roles, and definitions. It will also give practical examples of what processes can look like and how to implement them to fulfill the Medical Device Regulation. As the seminars are separated into two days, the participants will have some time for reflection and to prepare questions for the second day.
Anna and Anna have held seminars on the MDR subject before at other events, for example at assistive technology events in Sweden. They are hoping for interactive sessions with a lot of interesting discussions, as they have experienced before.
Understanding the intention and how legislation can be interpreted for low-risk products will strengthen our industry and help keeping the products at high quality.