MDCG 2021-9: Positon Paper on UDI Implementation for Contact Lenses & Spectacles 🆕

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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

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MDCG 2021-8: Clinical Investigation Application / Notification Documents 🆕