Post-market surveillance and materiovigilance — MDR obligations and internal organisation
Since the entry into application of Regulation (EU) 2017/745, post-market surveillance is no longer a peripheral process: it is audited by notified bodies, inspected by the ANSM and integrated into the manufacturer's technical documentation. PMS Plan, PSUR, trend report, incident notifications, FSCA management — the deliverables are multiplying and the regulatory deadlines are mandatory. This training gives QA and RA teams the keys to managing these obligations methodically, structuring internal responsibilities and producing documentation that meets the expectations of the competent authorities.
Audience Quality assurance managers (QA), regulatory affairs officers (RA), vigilance managers, and anyone involved in post-market surveillance processes within a manufacturer, importer or distributor of medical devices.
Learning objectives
- ▸ Identify the articles of the MDR 2017/745 applicable to PMS (Articles 83 to 92) and distinguish them from the equivalent ISO 13485 requirements regarding post-market surveillance
- ▸ Design a post-market surveillance plan (PMS Plan) that is structured, proportionate to the device's risk class, and articulated with the ISO 14971 risk management plan
- ▸ Draft or revise the mandatory documentary deliverables: PMS report or PSUR depending on the device class, PMCF report, trend report
- ▸ Describe the materiovigilance process compliant with the MDR: categorisation of serious incidents, notification deadlines to the ANSM, management of FSCA and safety recalls via EUDAMED
- ▸ Organise the internal interfaces between the vigilance, regulatory affairs, quality and management functions to ensure the consistency of the system
- ▸ Prepare the surveillance elements expected during an audit by a notified body or an ANSM inspection
Expected outcomes
- ✓ At the end of the training, participants have an operational mapping of their PMS/vigilance obligations under MDR, a documentary template applicable to their organisation, and a command of the regulatory notification deadlines and channels (ANSM, EUDAMED).
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 MDR 2017/745 regulation is recommended. The IA-REG-02 training (Complete manufacturer obligations under MDR) or IA-REG-04 (CE marking under MDR) provides suitable preparation. 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 OPCOs
- ·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 post-market surveillance (2 h)
- ·Chapter VII of the MDR (Articles 83 to 92): overview and obligations by economic operator
- ·Articulation of MDR / ISO 13485 (§ 8.2.1) / ISO 14971 (post-production activities)
- ·Respective roles of the manufacturer, the authorised representative, the importer and the distributor
- ·Overview of the competent authorities and EUDAMED in the surveillance system
- 02
Building and maintaining your PMS Plan (2 h 30)
- ·Expected structure and content of the surveillance plan: active and passive data sources, performance indicators, criteria for triggering a revision
- ·Articulation with the risk management plan and the clinical evaluation
- ·Exercise: critical analysis of a PMS Plan based on a practical case
- 03
Mandatory documentary deliverables: PMS Report, PSUR, PMCF report (3 h)
- ·PMS report versus PSUR: selection criteria according to the device class (Article 85 vs Article 86)
- ·Regulatory content of each deliverable, update frequency, links with the technical documentation
- ·PMCF report: integration into the overall clinical process
- ·Trend report (Article 88): methodology and thresholds
- ·Workshop: guided production of a PSUR skeleton based on a practical case
- 04
Materiovigilance: process, deadlines and documentation (3 h)
- ·Regulatory definitions: serious incident, FSCA (Field Safety Corrective Action)
- ·Process for categorising and assessing events
- ·Notification deadlines to the ANSM according to criticality (2, 7 or 15 days)
- ·Drafting the MIR (Manufacturer Incident Report) and follow-up reports
- ·Communication via EUDAMED: progress status and transitional best practices
- ·Management of safety recalls and communications to users
- 05
Internal organisation and preparation for inspections (3 h 30)
- ·Mapping of responsibilities: PRRC, vigilance manager, QA, RA, management
- ·Documentary procedures and instructions to maintain
- ·Interface with the management review: which PMS/vigilance data to integrate
- ·Preparation for notified body audits and ANSM inspections on the PMS process
- ·Role-play: simulation of an audit interview on the PMS/vigilance scope
Assessment of learning
Assessment methods
QCM of 20 questions at the end of the training covering the applicable MDR articles, the regulatory deadlines and the documentary deliverables, supplemented by a short role-play (analysis of an incident case and notification decision).
Certificate
Training certificate issued by ISOFAC Group at the end of the training, subject to full attendance over the two days. This certificate does not constitute a certification recognised by the RNCP or the Specific Directory (RS).
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.
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)
1 490 €
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 OPCOs
- ·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.