MDCG 2021-9: Positon Paper on UDI Implementation for Contact Lenses & Spectacles 🆕
The MDCG has published a new position paper on UDI requirements implementation for (i) contact lenses, (ii) spectacle frames, (iii) spectacle lenses and (iv) ready readers.
Key Takeaways:
- Discusses MDR requirements and highlights relevance to spectacles/lenses
- Practical application is still not formalised
- Clarification is provided on
o UDI assignment
o UDI Carrier labelling
o UDI &Device Registration
🔗 Original PDF: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-9_en.pdf