Medical Devices and Materiovigilance: the application of Regulation (EU) 2017/745 on medical devices (MDR) marked a turning point for clinical investigations. This regulation now provides a clear framework for all studies conducted in France involving a medical device (MD), whether or not it bears the CE mark, and whether used within or outside its intended purpose.
In January 2025, the ANSM (French National Agency for Medicines and Health Products Safety) will strengthen this framework with the publication of the “Notice to Sponsors – Part IV,” setting out new requirements regarding clinical materiovigilance.
Medical Devices and Materiovigilance: When Does it Apply?
There are two major situations that trigger materiovigilance obligations during a clinical trial:
- If the device is not CE-marked or is used outside its CE-marked indication: reporting obligations apply under Article 80 of the MDR.
- If the device is CE-marked (regardless of its class) and used within its intended purpose, but in a study involving heavy or invasive additional procedures: the same reporting obligations apply.
In all cases, when serious adverse events (SAEs) occur and are potentially related to the MD, Articles 87 to 90 of the MDR apply, covering post-market surveillance of the device.
What Events Must Be Reported?
The sponsor is required to systematically document:
- Events considered critical to study outcomes as per the protocol,
- Any serious adverse event (SAE),
- Any device malfunction that could lead to a SAE,
- Any new similar event.
Reporting must begin as soon as the clinical investigation is authorized to start. Adhering to this timeline is essential, as delays or omissions may result in non-compliance with regulatory requirements.
Reporting Timelines
The deadlines for reporting to ANSM depend on the nature and severity of the event:
- In case of an SAE involving death, life-threatening situations, or requiring immediate corrective action: reporting must occur within 2 calendar days.
- For all other events or updates: reporting must occur within 7 calendar days.
Additionally, the principal investigator must inform the sponsor within 3 days after becoming aware of the event. This responsiveness enables the sponsor to fulfil their obligations toward health authorities.
Reporting Process: Practical Guidance
Until the EUDAMED database becomes mandatory, reports must be submitted by email to EC.DM-COS@ansm.sante.fr. They should follow a structured format, particularly the Excel template recommended in MDCG 2020-10/2, and the email subject line should comply with the regulatory naming convention (e.g., YYYYMMDD_SAE_IDRCB or EUDAMED).
This transitional process ensures traceability until the full rollout of the EUDAMED portal, expected in 2025.
Special Cases: RIPH1, RIPH2, and RIPH3 Studies
Studies conducted under the Jardé Law, whether interventional or non-interventional, are also subject to these requirements. Two key points to remember:
- Any new information related to device safety must be submitted as outlined.
- For studies authorized before May 26, 2021, an annual safety report remains mandatory.
These requirements are in addition to those stemming from the European Regulation, making study management more complex if not properly anticipated.
How BluePharm Can Support You
Given the increasingly strict regulatory framework, BluePharm offers a comprehensive solution as a CRO specialized in medical devices:
- Implementation of integrated materiovigilance systems within clinical investigation management,
- Drafting and submission of SAE reports to ANSM within regulatory deadlines (within 48 hours),
- Centralized tracking of all events and compliant archiving with applicable regulations.
In Summary
Clinical materiovigilance is becoming a cornerstone of regulatory compliance for any investigation involving a medical device. Each trial must be supported by a detailed vigilance plan. In case of non-compliance, real risks exist: trial suspension, corrective audits, or even rejection by HAS.
Anticipating, structuring, and outsourcing this vigilance to seasoned professionals like BluePharm is now a key success factor for sponsors.
See article on the same subject: Post-market surveillance and vigilance for medical devices: anticipating feedback and ensuring compliance
