MDCG Guidance on Vigilance System for Urogynecological Surgical Mesh Implants
The article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
The article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
The article highlights the key points related to the current regulatory framework for clinical investigations conducted in Ireland.
The new article elaborates further on the aspects related to risk management in the context of medical devices to be used in the course of clinical investigations.
The new article describes in detail the approach to be applied with respect to labeling for medical devices undergoing clinical evaluation.
The article highlights the key points related to the information the Investigator’s Brochure should contain in order to meet the relevant regulatory requirements.