Medical Device Coordination Group (MDCG) released a second revision to its Surveillance Guidance for Medical Devices, aligning it with EU regulations on transitional provisions for medical devices and in vitro diagnostic devices (IVDs). This guidance is essential for manufacturers, notified bodies, and regulatory authorities, ensuring robust post-market surveillance (PMS) and vigilance activities to maintain device safety and performance.
Legacy Devices: These are medical devices that were approved under previous regulations and continue to be on the market under the new regulatory framework.
Surveillance: This refers to the systematic process of continuously monitoring the performance and safety of medical devices after they have been placed on the market. It includes activities such as collecting data on device performance, analyzing incident reports, and implementing corrective actions when necessary.
The revised guidance focuses on several critical areas to enhance the surveillance of medical devices within the EU. It outlines the roles and responsibilities of manufacturers, importers, distributors, and notified bodies, and emphasizes the importance of a proactive approach to PMS.
This guidance document outlines the activities to be performed by notified bodies12 as part of the appropriate surveillance defined in Article 120(3e) MDR, In addition to clarifying what notified bodies are required to verify, this guidance document also explains some of the obligations manufacturers face, especially in terms of their quality management system.
It is specified that appropriate surveillance is only applicable to devices that have MDD or AIMDD certificates. Devices that do not require a notified body under MDD are exempt from surveillance under Article 120, even if MDR requires it. In the absence of MDR-designated notified bodies issuing MDD or AIMDD certificates, surveillance responsibility ends on 25 September 2024.
After this date, the responsibility shifts to the notified body with which the manufacturer has an MDR certification agreement.
Following the information from the manufacturer, the notified body needs to identify:
• which of the existing MDD or AIMDD certificates are used to place devices on the market or put them into service,
• if their scopes remain unchanged,
• which devices are covered by the certificates, and
• which devices are covered by the formal application(s) according to Article 120(3c), point (e) MDR.
In addition, the notified body needs to ensure that their rights and duties as the notified body will continue to apply under their new status.
By following the revised guidance, manufacturers can ensure the safety and efficacy of their medical devices, ultimately protecting patient health and enhancing the overall quality of care. For a complete understanding of the revised guidance, refer to the full document available here.
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