Medical device vigilance in clinical trials is one of the most demanding regulatory requirements introduced by Regulation (EU) 2017/745 (MDR). Since the Regulation became fully applicable on 26 May 2021, sponsors conducting clinical investigations involving medical devices have had to comply with stricter reporting obligations, shorter notification timelines, and evolving reporting pathways as EUDAMED is progressively deployed.
Understanding these requirements is essential to ensure participant safety, maintain regulatory compliance, and successfully navigate inspections by competent authorities.
Medical Device Vigilance in Clinical Trials: Definition and Scope
Medical device vigilance in clinical trials refers to the monitoring, assessment, documentation, and reporting of serious adverse events, device deficiencies, and other reportable safety issues occurring during a clinical investigation involving a medical device.
These obligations apply to all clinical investigations conducted under Regulation (EU) 2017/745, whether the device is CE marked or not, whenever the study falls within the scope of the MDR and national clinical investigation requirements.
Two main situations trigger specific medical device vigilance in clinical trials obligations:
- Non-CE marked medical devices or CE-marked devices used outside their intended purpose
Reporting requirements are governed by Article 80 of the MDR, which establishes reinforced vigilance obligations throughout the clinical investigation.
2. CE-marked medical devices used within their intended purpose but involving additional invasive or burdensome procedures
Even when the device is marketed for its intended use, vigilance requirements continue to apply if the investigation introduces procedures beyond standard clinical practice.
Medical Device Vigilance in Clinical Trials: Reporting Timelines and Notification Pathways
Regulation (EU) 2017/745 establishes strict reporting deadlines based on the severity of the event. In France, until the EUDAMED Vigilance module becomes fully operational, reports continue to be submitted to the French National Agency for the Safety of Medicines and Health Products (ANSM) using the MDCG 2020-10/2 reporting form.
| Event Type | Reporting Deadline | Current Reporting Pathway |
| Serious incident presenting an immediate life-threatening risk | Without delay and no later than 2 calendar days | ANSM (MDCG 2020-10/2 form) |
| Other serious incidents | Without delay and no later than 7 calendar days | ANSM (MDCG 2020-10/2 form) |
| Device deficiency that has caused or could have caused a serious incident | Same reporting timeline as serious incidents (2 or 7 days depending on the situation) | ANSM and Ethics Committee (CPP) |
| Annual Safety Report (ASR) | Once per year | ANSM / EUDAMED (once fully operational) |
Important: Since January 2025, the ANSM has strengthened its guidance through the publication of the “Notice to Sponsors – Part IV”, which clarifies the operational requirements applicable to vigilance during medical device clinical investigations conducted in France. This document has become the primary national reference for sponsors managing clinical investigations involving medical devices.
The Five Most Common Medical Device Vigilance Mistakes
In practice, most non-compliance findings identified during inspections stem from a limited number of recurring errors.
1. Confusing Medical Device Vigilance with Pharmacovigilance
Although both systems aim to protect patient safety, they rely on completely different regulatory frameworks, reporting procedures, databases, and submission routes.
Sponsors with extensive experience in medicinal product trials sometimes incorrectly apply pharmacovigilance procedures to medical device investigations—for example by reporting through EudraVigilance instead of the appropriate national competent authority.
2. Incorrectly Classifying a Serious Incident
Not every device malfunction qualifies as a reportable serious incident. However, any event involving a medical device that has caused, or could have caused, death, serious deterioration in a participant’s health, or a life-threatening condition must be reported without delay.
Incorrectly assessing the severity of an event is one of the most common findings during ANSM inspections and may expose sponsors to significant regulatory consequences.
3. Using an Incorrect or Outdated Reporting Form
During the transitional period before the full deployment of EUDAMED, serious incidents must be reported using the MDCG 2020-10/2 reporting form.
Some sponsors continue to use obsolete national reporting templates that are no longer compliant with the MDR. This frequently results in requests for additional information or delays in the regulatory assessment process.
4. Failing to Notify the Ethics Committee (CPP)
Unlike medicinal product trials, certain reportable events occurring during medical device clinical investigations require parallel notification to both the ANSM and the French Ethics Committee (Comité de Protection des Personnes – CPP).
Failure to submit both notifications when required constitutes a regulatory non-compliance specifically highlighted by the ANSM.
5. Lack of Traceability of the Investigational Medical Device
The MDR requires complete traceability through the Unique Device Identifier (UDI) system.
During an inspection, the inability to identify the device involved in an incident—such as its batch number, serial number, or UDI—may be considered a major non-conformity. Robust traceability procedures should therefore be implemented from the beginning of every clinical investigation.
EUDAMED: What Will Change for Medical Device Vigilance in Clinical Trials?
Once fully operational, EUDAMED will become the central European platform for reporting medical device vigilance in clinical trials, including serious incidents, field safety corrective actions, and periodic safety reports.
In practice, four of the six EUDAMED modules—Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance—became mandatory on 28 May 2026 following Commission Decision (EU) 2025/2371.
The Vigilance and Clinical Investigations modules are not yet mandatory. The Vigilance module is currently undergoing an independent audit, and its mandatory implementation is not expected before the end of 2026.
Although these two modules are not yet operational, sponsors are strongly encouraged to register now in the Actors module and obtain their Single Registration Number (SRN).
The SRN will serve as the foundation for future interactions with the Clinical Investigations and Vigilance modules, including the electronic submission of serious incident reports, Annual Safety Reports (ASRs), and other regulatory documentation once these modules become fully operational.
BluePharm: Your Medical Device Vigilance Expert
Since its creation, BluePharm has specialized in supporting sponsors conducting clinical investigations involving medical devices.
We assist both industrial and academic sponsors in implementing MDR-compliant medical device vigilance in clinical trials, including:
- Development of vigilance Standard Operating Procedures (SOPs);
- Training for investigators, sponsors, and CRO vigilance teams;
- Preparation and submission of reports to the ANSM;
- Readiness for EUDAMED implementation;
- Support during regulatory inspections and audits.
Following the publication of the ANSM Notice to Sponsors – Part IV in January 2025, we have integrated the latest French regulatory requirements into every clinical investigation project we support.
Are you planning or conducting a clinical investigation involving a medical device?
Contact BluePharm for an independent review of your medical device vigilance in clinical trials procedures or to implement an MDR-compliant vigilance system that meets current European and French regulatory requirements.
