En su reunión del 17 de febrero el subgruupo de UDI del MDCG trato la aplicación del UDI a estos productos en particular.
AGENDA
1. Opening, adoption of the agenda
2. Update from the European Commission
3. Organisational matters & Co-Chairmanship
4. Proposed list of UDI EUDAMED Enumerations (Clinical size and Critical warnings/contraindications) – Presentation from Commission
5. UDI labelling of convenience kits of surgical procedure – Presentation
6. Spectacles/Frames: Rules for UDI assignment – Discussion on solution
7. Contact Lenses: Rules for UDI Assignment – Discussion on solution
8. Implant card guidance MDCG 2019-8
– Discussion on minor revisions
– Use of nomenclature in the Implant Card
– Dental Implants
9. Comparison between EU-US UDI systems – Presentation from MedTech and discussion
10. Draft Amendment to MDCG 2018-1 v2 clarifying specific UDI-Triggers – Possible Endorsement
11. IMDRF UDI application guidance – Discussion on potential use at EU level
12. Wrap-Up & Discussion on next steps for the group
13. AOB