Materiovigilance — Organisation, mandatory reporting and crisis management
When an incident occurs on a medical device, every hour counts. Knowing how to identify a reportable event, notify within regulatory deadlines and steer the crisis response without improvisation: these are skills that the MDR 2017/745 regulation now makes essential. This intensive day gives vigilance professionals concrete tools to structure their organisation, master their reporting obligations and handle critical situations methodically.
Audience Vigilance officers, quality assurance (QA) managers and regulatory affairs (RA) managers in companies manufacturing, distributing or importing medical devices.
Learning objectives
- ▸ Distinguish between the different categories of incidents and serious incidents within the meaning of MDR 2017/745 and the applicable MDCG guidance, in particular MDCG 2023-3
- ▸ Apply the regulatory reporting deadlines to the ANSM and via EUDAMED (immediate, 15-day, 30-day deadlines) depending on the nature of the event
- ▸ Build or audit an internal materiovigilance process compliant with MDR requirements, linking complaints, CAPA and PMS
- ▸ Draft an initial incident notification and a follow-up report that can be presented to the competent authorities
- ▸ Implement a vigilance crisis management plan, including internal escalation, regulatory communication and Field Safety Corrective Actions (FSCA)
- ▸ Prepare the organisation for ANSM inspections and internal audits relating to vigilance
Expected outcomes
- ✓ A materiovigilance procedure template directly adaptable to your company context
- ✓ A reporting decision tree
- ✓ A crisis plan framework
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
Basic knowledge of the regulatory framework for medical devices (MDR 2017/745). Operational experience in quality or regulatory affairs is recommended. No formal blocking prerequisite.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi certified and is not fundable via the OPCO
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Regulatory framework of materiovigilance under MDR (1h30)
- ·Definition and scope of materiovigilance according to MDR 2017/745
- ·Articulation with post-market surveillance (PMS), the PSUR and PMCF
- ·Role and obligations of the different economic operators (manufacturer, authorised representative, importer, distributor)
- ·Competent authorities: ANSM, EMA, SCENIHR network
- ·EUDAMED: vigilance module, deployment status and practical obligations
- 02
Identification and qualification of reportable incidents (1h30)
- ·Definition of the serious incident and of non-serious incidents
- ·Qualification criteria according to MDCG 2023-3 and ANSM documents
- ·Reporting decision tree: practical exercise on anonymised real cases
- ·Boundary between complaint, product non-conformity and vigilance incident
- ·Link with the CAPA register and the non-conformity handling process
- 03
Mandatory reporting: deadlines, formats and EUDAMED (1h30)
- ·Initial notification, intermediate report, final report: content and deadlines (2 days, 15 days, 30 days depending on severity)
- ·Practical use of the EUDAMED vigilance module: demonstration and guided exercise
- ·Communication to foreign authorities for multi-market manufacturers
- ·Field Safety Notices (FSN) and Field Safety Corrective Actions (FSCA): triggering and content
- 04
Internal organisation and vigilance documentation (1h)
- ·Architecture of a materiovigilance procedure compliant with ISO 13485 and MDR
- ·Internal roles and responsibilities: PRRC, vigilance officer, management
- ·Monitoring indicators and periodic vigilance reviews
- ·Articulation vigilance / PSUR / trend analysis
- 05
Vigilance crisis management: method and simulation (1h30)
- ·Definition of a vigilance crisis situation (batch recall, multi-country FSCA, ANSM alert)
- ·Crisis management plan: crisis unit, decision escalation, regulatory and press communication
- ·Simulation on a crisis scenario (table-top exercise): post-exercise analysis and feedback
- ·Communication to users and healthcare establishments
- ·Lessons learned and continuous improvement of the process
Assessment of learning
Assessment methods
20-question QCM at the end of the day covering reporting obligations, regulatory deadlines and incident qualification criteria. Supplemented by a short scenario exercise: qualification of a provided incident case and drafting of a concise initial notification. Results are communicated individually.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full participation in the day. This certificate does not constitute a certification recognised by the RNCP or the Specific Register (RS) of France Compétences.
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Materials provided
- ·Complete course materials in PDF format
- ·Exercise booklet: decision trees, procedure template, crisis plan framework
- ·Reference documentation: extracts from MDR 2017/745, MDCG 2023-3, ANSM forms
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
890 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi certified and is not fundable via the OPCO
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.