MDR in practice — Mastering the manufacturer's obligations end to end
Are you a manufacturer, regulatory or quality manager, and do you need to demonstrate your compliance with Regulation (EU) 2017/745 without getting lost in the complexity of the articles? This training gives you the map and the compass: in two days, you map out the full set of obligations that fall on the manufacturer, from design to post-market surveillance, and you leave with tools that can be directly put to use in your organization.
Audience Regulatory affairs managers, quality managers, medical device project managers, and members of management involved in regulatory compliance.
Learning objectives
- ▸ Identify all the obligations incumbent on the medical device manufacturer under Article 10 of MDR 2017/745 and link them to the applicable annexes
- ▸ Describe the specific responsibilities of the Person Responsible for Regulatory Compliance (PRRC) and the conditions for designation under Article 15
- ▸ Structure or assess a Quality Management System (QMS) aligned with the requirements of Annex IX and with ISO 13485
- ▸ Apply UDI traceability and EUDAMED registration requirements to concrete market-placement situations
- ▸ Build or audit a Post-Market Surveillance (PMS) plan integrating PMCF, PSUR and SSCP obligations according to the device class
- ▸ Distinguish vigilance obligations (medical device vigilance, serious incident reporting) and chain them into a documented process compliant with ANSM/EUDAMED requirements
Expected outcomes
- ✓ An obligations matrix structured by process
- ✓ A compliance self-assessment of their organization
- ✓ A prioritized roadmap of corrective actions
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 medical device sector recommended. Having completed IA-REG-01 (MDR Fundamentals) or having professional experience in a QA/RA role is an asset, but not mandatory.
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 eligible for funding through 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
Mapping the manufacturer's obligations (2 h)
- ·Identifying manufacturer status within the meaning of the MDR
- ·Scope of Article 10: organizational, documentary and surveillance obligations
- ·Distinguishing manufacturer, authorized representative, importer, distributor
- ·Exercise: positioning participants according to their actual status
- 02
The PRRC: designation, role and responsibilities (1 h 30)
- ·Required qualification conditions (Article 15)
- ·Positioning the PRRC in the organizational chart
- ·Possible outsourcing: conditions and limits
- ·Practical case: drafting a PRRC mission sheet
- 03
QMS and technical documentation: what the MDR requires (2 h 30)
- ·QMS requirements (Annex IX, Section 2) and their articulation with ISO 13485
- ·Mandatory structure of the technical documentation (Annexes II and III)
- ·Change control and documentary traceability
- ·Workshop: diagnosing incomplete technical documentation
- 04
UDI, EUDAMED and registration of operators (1 h 30)
- ·Structure of the UDI system (UDI-DI / UDI-PI)
- ·Obligations of assignment, application and transmission to EUDAMED
- ·Registration of economic operators and devices
- ·Practical case: simulating a EUDAMED registration form
- 05
Post-Market Surveillance (PMS): PMCF, PSUR, SSCP (2 h)
- ·Logic of the PMS plan and link with the clinical evaluation
- ·Differentiated requirements according to the device class
- ·Regulatory content of the PSUR and the SSCP
- ·Workshop: structuring a PMS plan for a Class IIb device
- 06
Vigilance, reporting and incident management (1 h 30)
- ·Serious incidents and field safety corrective actions (FSCA)
- ·Regulatory deadlines for reporting to the ANSM
- ·Process for escalating to EUDAMED
- ·Practical case: handling a mock report
- 07
Review, self-assessment and roadmap (1 h)
- ·Article 10 compliance self-assessment grid
- ·Building a prioritized roadmap
- ·Q&A and synthesis of the points of vigilance specific to each participant
Assessment of learning
Assessment methods
Interactive quizzes at the end of each module to anchor learning, supplemented by individual formative feedback from the trainer. Final evaluation: a 20-question QCM covering all modules, administered at the end of the second day.
Certificate
Training certificate issued by Isofac Group upon completion of the training, subject to full attendance over the two days. This certificate does not constitute a certification recognized 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 eligible for funding through 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.