The article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
Table of content
The Medical Device Coordination Group (MDCG), has published a guidance document dedicated to the vigilance system for CE-marked medical devices, namely, urogynecological surgical mesh implants used for pelvic organ prolapse repair and stress urinary incontinence. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by the parties involved to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The MDCG also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction
The purpose of this Device Specific Vigilance Guidance (DSVG) is to standardize vigilance reporting and offer detailed guidance for manufacturers of Urogynecological Surgical Mesh Implants used in Pelvic Organ Prolapse (POP) repair and Stress Urinary Incontinence (SUI). This document is intended to clarify the reporting procedures to the relevant Competent Authority, aligning with the requirements of Regulation (EU) 2017/745 on medical devices (MDR).
It is important to mention that this DSVG does not replace or expand on the existing requirements but provides specific instructions on reporting incidents and serious incidents involving Urogynecological Surgical Mesh Implants used for POP repair and SUI.
Reporting Scope
According to the guidance, medical device manufacturers should evaluate each event based on its individual merits to ensure compliance with statutory reporting requirements within the MDR.
Individual Serious Incident
According to Article 87 MDR, manufacturers are obliged to report serious incidents to the relevant Competent Authority. Serious incidents are defined in Article 2(65) MDR.
This includes scenarios where the manufacturer is uncertain about the reportability of the incident or requires additional time to ascertain the root cause, as indicated in Article 87(6) and (7) MDR. Notifications must be reported within the timeframes outlined in Article 87(2) to (5) MDR.
For further clarity on what constitutes a serious incident and the applicable reporting timelines, stakeholders should refer to MDCG 2023-31 “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices”.
Periodic Summary Reporting
As further explained by the MDCG, the Periodic Summary Report (PSR) is an alternative reporting method allowing manufacturers to report similar serious incidents with the same device or device type in a consolidated manner, in agreement with the respective national Competent Authority. This approach is suitable when similar serious incidents occur with the same device type, the root cause is identified, or a field safety corrective action has been implemented, as defined in Article 87(9) MDR.
The format, content, and frequency of these reports should be agreed upon with the Coordinating Competent Authority. Until EUDAMED becomes fully functional, stakeholders should follow MDCG 2021-1 Rev. 1 for harmonized administrative practices and alternative technical solutions.
Trend Reporting
Trend reporting requirements are detailed in Article 88 MDR. Manufacturers should report to a Competent Authority any statistically significant increase in the frequency or severity of non-serious incidents or expected undesirable side effects that could impact the benefit-risk analysis.
These trends, identified by the manufacturer, indicate a potential shift in the risk-benefit ratio. For further information on what constitutes incidents and undesirable side-effects, interested parties should refer to MDCG 2023-3 “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices”.
Examples of Device-Related Problems
The guidance also contains a table that provides examples of Urogynecological Surgical Mesh Implants used for POP repair and SUI, illustrating what should be reported as device-related problems that caused or contributed to incidents or serious incidents. It is also important to mention that the list is provided for illustrative purposes and is incomplete.
Clinical References and Guidelines
Manufacturers of Urogynecological Surgical Mesh Implants used for POP repair and SUI should refer to clinical references or current clinical guidelines to identify incident examples and complications. Local clinical guidelines may also be useful in identifying relevant incident examples and complications.
IMDRF Terminologies for Categorized Adverse Event Reporting
As it is mentioned by the MDCG, manufacturers should use the text descriptions of Medical device problems (IMDRF Annex A) and Health effects – Clinical signs and symptoms (IMDRF Annex E) as examples of what should be reported. These descriptions refer to the IMDRF Annex A and E release No. 2023.
It is vitally important for manufacturers to consult the most recent version of the IMDRF adverse event code.
Conclusion
In summary, the present guidance is intended to provide a comprehensive understanding of the vigilance system for CE-marked Urogynecological Surgical Mesh Implants used in POP repair and SUI to assist manufacturers in ensuring compliance with the relevant reporting requirements set forth under the MDR. The document highlights the key points to be taken into consideration by the parties involved in operations with the said medical devices and outlines their responsibilities.
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