The article provides a general overview of the EU vigilance regulatory framework.
Table of content
The Medical Device Coordination Group (MDCG) has published a guidance document dedicated to the vigilance terms and concepts based on Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). In particular, the document provides definitions of the most important terms and concepts and also provides additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure the accurate interpretation of the terminology used.
It is also important to mention that the document is based on the existing legal framework and could be subject to changes and amendments, should this be reasonably necessary to reflect corresponding changes to the underlying legislation.
Introduction
This document provides an in-depth explanation of critical terms and concepts outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Its primary purpose is to promote a consistent and harmonized interpretation of vigilance requirements among competent authorities, economic operators, and other stakeholders involved in the regulation and monitoring of medical devices.
The document adapts some definitions from the earlier Guidelines on a Medical Devices Vigilance System while making modifications to align with the MDR and IVDR frameworks. The term “devices” is used broadly to encompass medical devices, their accessories, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices, and their accessories.
Additionally, any reference to “the Regulations” pertains to both MDR and IVDR collectively. This resource is not exhaustive and must be read alongside the official Regulations, relevant standards, and guidance documents issued by the Medical Device Coordination Group (MDCG).
Defining “Incident” and “Serious Incident”
According to the document, a clear distinction between an incident and a serious incident is vitally important for ensuring appropriate regulatory responses. An incident is defined in Article 2(64) of the MDR and Article 2(67) of the IVDR.
It refers to any malfunction, performance deterioration, use error caused by ergonomic features or inadequacy in the manufacturer’s information. In addition, for in vitro diagnostic medical devices (IVDs), an incident may include harm resulting from a medical decision based on incorrect data generated by the device.
By contrast, a serious incident, as outlined in Article 2(65) of the MDR and Article 2(68) of the IVDR, represents a subset of incidents with more severe consequences. Such incidents may lead, directly or indirectly, to a temporary or permanent serious deterioration in health or a significant public health threat.
While all serious incidents are incidents, not all incidents are serious incidents. The reporting requirements differ accordingly.
Serious incidents must be reported to the competent authorities as specified in Articles 87 (MDR) and 82 (IVDR), while incidents that do not meet the criteria of seriousness must still be documented within the manufacturer’s quality management system.
Criteria for Reporting a Serious Incident
For an incident to be classified as a serious incident, it must meet three core criteria: the occurrence of an incident, its linkage to serious outcomes, and the establishment of a causal relationship.
The first criterion focuses on the occurrence of an incident involving the device. Examples of incidents include device malfunctions that prevent it from achieving its intended purpose, manufacturing errors (such as sterilization failures), and ergonomic flaws leading to user errors.
Additionally, inadequate instructions or unclear labeling from the manufacturer can lead to incorrect use, while mislabeled diagnostic reagents and undesirable side effects, such as allergic skin reactions, are also examples of reportable incidents. The second criterion concerns the potential or actual impact of the incident.
It considers whether the incident could lead to serious health outcomes, including temporary or permanent health deterioration, life-threatening conditions, or a public health threat. This includes indirect consequences, such as delayed medical interventions resulting from incorrect test results.
For example, a faulty diagnostic test might result in misdiagnoses that delay critical treatments, ultimately worsening the patient’s condition. The third criterion examines whether there is a causal relationship between the device and the serious incident.
This relationship can be established through clinical evidence, input from healthcare professionals, the manufacturer’s preliminary assessments, or historical data of similar incidents. If there is reasonable suspicion that the device may have contributed to the incident, even if definitive proof is lacking, the manufacturer must proceed with reporting.
Examples of Serious Outcomes
Serious incidents can manifest in various ways. They may involve life-threatening injuries or illnesses, chronic diseases, or conditions that require hospitalization or prolong existing hospital stays.
For instance, if a medical device used during surgery malfunctions and necessitates a longer, riskier procedure, it could be deemed a serious incident. Other scenarios include medical or surgical interventions to prevent permanent impairment or loss of bodily function, as well as cases of fetal distress, birth defects, or congenital impairments linked to the device’s performance.
Public health threats also fall under the category of serious incidents. These may include situations where a faulty in vitro diagnostic test used for screening infectious diseases leads to the release of contaminated blood supplies, potentially exposing a large number of individuals to infection.
Additionally, cyberattacks targeting critical life-supporting devices could be considered public health threats. Widespread distribution of non-sterile devices labeled as sterile also constitutes a public health threat, particularly when it involves vulnerable populations, such as pregnant women or individuals with chronic illnesses.
Causal Assessment and Manufacturer Responsibility
Manufacturers are responsible for assessing whether there is a potential causal link between their device and a reported incident. This assessment must consider factors such as the clinical plausibility of the event, expert opinions from healthcare professionals, and any relevant technical documentation.
Historical data on previous similar incidents can also provide valuable context. In cases where multiple devices or medications are involved, establishing causality may be challenging.
However, if there is any reasonable suspicion that the device may have contributed to the incident, the manufacturer must act conservatively and report the event to the relevant authority. The Regulations emphasize that uncertainty is not a valid reason for failing to report.
If a manufacturer becomes aware of a potentially reportable incident but cannot definitively rule out its seriousness, it must report it within the prescribed timeframes under Articles 87 (MDR) and 82 (IVDR).
Conclusion
In summary, the vigilance framework under the MDR and IVDR aims to enhance patient safety by ensuring timely documentation and reporting of incidents and serious incidents. Under the existing legal framework described in the document, medical device manufacturers are responsible for maintaining robust quality management systems to track and evaluate incidents while adhering to their reporting obligations when serious outcomes are identified or suspected.
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