MDCG 2018-1 Update on UDI-DI 🆕

The MDCG has updated the MDCG 2018-1 Rev.4 “Guidance on BASIC UDI-DI and changes to UDI-DI” document with some minor updates.  The main change is the addition of information on the maximum number of reuses on page 4.

 Key Takeaways:

• -          “Annex VI Part B, 17 states that the manufacturer shall provide to the UDI database the maximum number of reuses of the device concerned, if:

• o   devices where based on clinical evidence and as a result of the risk management process, a manufacturer has demonstrated a maximum number of reuses, which should not be surpassed

• -          Max number of uses depends on multiple factors, such as material, use, and process changes.

• -          “This guidance does not address requirements for reprocessed devices, systems or procedure packs, software, Annex XVI, nor for cases of parallel trade or own brand labelling. Specific requirements for those products are addressed in specific guidance.”

🔗 Original PDF: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2018-1_guidance_udi-di_en.pdf