MDCG 2023-3 Rev.1: New Vigilance Requirements for Medical Device and IVD Manufacturers

The recent revision of the MDCG 2023-3 Rev.1 document introduces significant changes for manufacturers of medical devices (MDs) and in vitro diagnostic devices (IVDs) under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). What are the key takeaways for ensuring regulatory compliance and safety? Here’s what manufacturers need to know to integrate these new vigilance requirements in 2025.

Key Points of the MDCG 2023-3 Rev.1 Guide

1. Definitions and Reporting Obligations: This update clarifies the definitions of “incident” and “serious incident,” specifying criteria, timelines, and reporting processes for serious incidents. Special emphasis is placed on the importance of Field Safety Corrective Actions (FSCA), preventive and corrective measures aimed at minimizing safety risks.

2. Incident Categories in the MDCG Guide: The distinctions between “incident” and “serious incident” are made explicit, with reinforced reporting obligations in cases of erroneous diagnoses leading to indirect harm, expected erroneous results, and serious public health threats.

3. User Errors and Definitions: The update details various types of use errors, such as “use error,” “abnormal use,” and “use-error due to ergonomic features,” with clear reporting implications for each case.

4. FSCA Requirements: Field Safety Corrective Actions (FSCAs) include recalls or product modifications for safety reasons. The guide stresses the importance of promptly communicating these actions to the relevant authorities and users through consistent safety notices across all EU Member States.

5. Serious Incident Reporting Timelines: The guide clarifies reporting timelines according to the severity of incidents. Manufacturers must understand the “awareness date” of the incident, which triggers the reporting deadlines. Some situations, such as serious public health threats, require immediate reporting, within two days.

Key Changes in the MDCG 2023-3 Rev.1 Guide Compared to the Previous Version

Changes introduced in October 2024 bring several new elements:

• References to IVDR Regulations: This guide is now aligned with IVDR, with specific references to in vitro diagnostic devices.
• New Questions Added for IVDs: Questions on indirect risks from diagnostic errors and expected erroneous results were added to address expanded vigilance requirements.
• Refined Definitions: Definitions and criteria for incident reporting have been refined for greater clarity.
• Structural and Textual Modifications: Renumbering of questions, updated footnotes, and the addition of scenarios for IVDs.

Points of Vigilance for MD and IVD Manufacturers

With these new requirements, manufacturers must be proactive in ensuring compliance:

1. Reinforced Reporting Timelines: Serious incidents, especially public health threats, must be reported quickly. The “awareness date” of the incident is essential for meeting deadlines.

2. Safety Criteria for In Vitro Diagnostic Devices (IVDs): For IVDs, incidents linked to erroneous diagnostic information must be rigorously documented, as they can lead to inappropriate or delayed medical decisions.

3. FSCA Communication: Any corrective action, especially if it impacts countries outside the EU, must be reported to the competent authorities with a harmonized communication strategy across Member States.

4. Documentation of Non-Reportable Incidents: Non-reportable incidents must be documented within the quality management system and may be subject to trend reporting, as specified by MDR and IVDR.

5. Monitoring and Managing Use Errors: Use errors due to ergonomic features must be documented and reported if they risk leading to serious incidents.

Conclusion on the MDCG 2023-3 Rev.1 Guide

We already knew that medical device regulation was becoming increasingly stringent, and this MDCG 2023-3 Rev.1 guide confirms this trend. More than ever, medical device and in vitro diagnostic manufacturers must embed vigilance and safety into their daily practices. This is not just about compliance, but also about fostering a corporate culture where patient safety and care quality come first.

With strengthened requirements for documentation, responsiveness in the event of serious incidents, and rigorous management of use errors, this guide reminds manufacturers that every detail counts. Now, even minor incidents must be monitored, analyzed, and sometimes reported. The strict deadlines—sometimes as short as two days for public health threats—show that responsiveness is no longer an option but an obligation.

This document is more than a regulatory update; it’s a reminder that, to remain competitive in the European market, manufacturers must not only meet legal requirements but also adopt a proactive approach to safety. Anticipating, documenting, and acting quickly are the new imperatives for the industry.

Ultimately, this shift toward increased vigilance in medical devices and IVDs can be seen as an opportunity. Beyond compliance, this rigor in incident management processes and corrective action communication helps build trust among users and health authorities in medical devices. In 2025, those who successfully integrate these requirements into their core business strategy will be the true winners in this increasingly demanding regulatory landscape.

CSDmed: Your Partner in the Transition to MDR 2017/745

The European MDR 2017/745 introduces new requirements for medical devices, with more stringent demands on documentation, clinical evaluations, PMS procedures, and many other aspects of regulatory compliance.

At CSDmed, we help clients—whether start-ups, manufacturers, importers, or distributors—overcome the challenges of transitioning to MDR. Our team of experts and specialized consultants will guide you through the entire process, from achieving compliance to final certification.

🔗 Contact us to learn how our team can support you in successfully navigating your MDR transition.