Miriam Di Fonzo -


The Italian Medicines Agency (AIFA) recently introduced a guideline for Notified Bodies planning to submit a consultation for ancillary medicinal substances in Class III medical devices. This guideline aims to simplify the procedural, formatting, and dossier requirements for the consultation process, facilitating easier and clearer compliance pathways.

AIFA’s guideline is a significant step towards enhancing regulatory clarity and ensuring patient safety in the development and approval of medical devices. By simplifying the consultation process, AIFA supports the industry’s progress and innovation. For more details, visit AIFA’s website.

Regulatory Pharma Net (RPN) can support you assess  the impact of this new guideline on your medical devices. We are available to provide your company with any updates on the medical device regulatory framework and to assist on all regulatory needs.

Feel free to contact us at info@regulatorypharmanet.com

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