Eudamed and in-vitro diagnostic medical devices

EESC opinion: Eudamed and in-vitro diagnostic medical devices

Key points

The EESC :

  • calls for the transitional periods for certain high-risk in vitro diagnostic medical devices (IVDs) to be extended and calls for a pragmatic, consistent framework to provide advance warning about supply disruptions and foster collaboration among manufacturers, independent conformity assessment bodies (‘notified bodies’) and regulatory authorities; this will ensure a high level of transparency and preparedness across the EU;
  • stresses the need to involve healthcare professionals in reporting shortages, and calls for a system that includes reports from both manufacturers and healthcare professionals in order to improve the timeliness and accuracy of shortage notifications;
  • emphasises the need for comprehensive training programmes for all stakeholders in the medical device sector, including ‘train-the-trainer’ programmes; this will ensure widespread dissemination of regulatory and technical competencies;
  • highlights the importance of SMEs in the medical device sector due to their dynamic and adaptable nature, and calls for support mechanisms such as subsidies and simplified compliance pathways to enhance their innovative capabilities and competitive edge;
  • suggests that an EU-wide platform be set up to facilitate dialogue between stakeholders, including SMEs, healthcare professionals, manufacturers and regulatory bodies; this will make it possible to address challenges and share best practices in medical device innovation and regulation.

For more information, please contact the INT Section Secretariat




EESC opinion on Eudamed and in-vitro diagnostic medical devices
Avis CESE sur EUDAMED et dispositifs médicaux