Gain market insight & a deeper understanding of EUDAMED requirements. Join the EUDAMED Leadership Council!

by Innovit Corporate Affairs | November 10, 2021 | Blog

Innovit is excited to announce the formation of a EUDAMED Leadership Council Group on LinkedIn which includes participants from a number of leading medical device manufacturers including Arthrex, B. Braun, Bio-Rad, Medtronic, 3M, Molnlycke, Ascensia Diabetes. 

The EUDAMED Leadership Council is a representative advisory body that provides informed guidance, advice, and/or recommendations on the European Commission’s EUDAMED data requirements under MDR and IVDR.   

The formation of this Leadership Council represents a commitment on the part of Innovit and its members to their share expertise & practical experiences, and to leverage the strengths of each participant towards this common goal. 

The EUDAMED Leadership Council is composed of subject matter experts in the medical device industry.  In addition to plenary meetings of the full Leadership Council, work may be carried out when needed, to support short-term, intermediate, or long-term projects.  Meetings of the Leadership Council are held monthly or on an as needed basis as defined by the members. 

The objectives of the group include: 

  • Help the industry navigate the European Commission’s EUDAMED data compliance requirements. 
  • Share practical experience and insights to machine-to-machine (M2M) data submission for EUDAMED.   
  • Connect EUDAMED business professionals looking to improve knowledge about EUDAMED compliance and bring fresh perspectives. 
  • Improve collaboration in the industry by sharing best practices in master data management and regulatory data submissions. 
  • Discuss challenges and technology issues related to working with the European Commission and specifically, DG Sante. 
  • Ensure compliance with EU-MDR and the EUDAMED system.  

We recently opened our LinkedIn Group to more members and by joining you can gain the latest market intelligence and a deeper understanding of EUDAMED regulatory data requirements.  We also ran a webinar to share our latest experiences in machine-to-machine (M2M) testing for EUDAMED data submissions.  By joining this LinkedIn group, you will have access to this recording as well as many other documents and practical guides to help you navigate your EUDAMED data compliance journey in the months ahead.