Importers and distributors under MDR — Mastering your obligations and securing your operational compliance
Since the full application of Regulation (EU) 2017/745, importers and distributors are no longer mere logistics intermediaries: they are economic operators in their own right, subject to precise documentary, vigilance and regulatory cooperation obligations. A single failure — non-compliant labelling, missing EUDAMED registration, failure to report an incident — can engage their direct liability towards the ANSM and the European competent authorities. This intensive virtual-classroom day gives you the keys to map your obligations, structure your procedures and respond to an inspection without gaps.
Audience Quality and regulatory affairs managers, purchasing and logistics managers, and general managers of companies importing or distributing medical devices on the European market.
Learning objectives
- ▸ Distinguish the roles of importer, distributor and authorised representative within the meaning of MDR 2017/745, and identify the obligations specific to each status under Articles 13 and 14
- ▸ Apply the mandatory checks required before making a medical device available on the market (CE marking, declaration of conformity, UDI, languages of the instructions for use)
- ▸ Set up the registrations required in EUDAMED and ensure they are kept up to date within the regulatory deadlines
- ▸ Structure internal processes for managing non-conformities, recalls and incident reporting in accordance with the MDR vigilance requirements
- ▸ Organise documented cooperation with the manufacturer, the authorised representative and the competent authorities in the event of an investigation or inspection
- ▸ Produce or check the constituent elements of an incoming verification procedure, immediately applicable within the organisation
Expected outcomes
- ✓ At the end of the day, each participant has a personalised map of their regulatory obligations, an incoming verification procedure template, and a checklist covering the EUDAMED, UDI and vigilance requirements applicable to their activity.
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
A general understanding of how the medical device market operates is recommended. No formal regulatory prerequisite is required. The IA-REG-01 training (Fundamentals of MDR 2017/745) may usefully be taken beforehand.
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
Mapping the roles and responsibilities of economic operators (1 h)
- ·MDR definitions: manufacturer, authorised representative, importer, distributor
- ·Criteria for qualifying the role according to the supply chain
- ·Special cases: repackaging, relabelling, Article 16 MDR (distributor acting as a manufacturer)
- ·MDCG 2021-27 guidance: principles for interpreting Articles 13 and 14
- 02
Verification obligations prior to making the device available (1 h 30)
- ·Mandatory verification checklist: CE marking, notified body identification number, EU declaration of conformity, instructions for use in the national language, UDI
- ·Handling devices that are non-compliant on receipt: isolation, informing the manufacturer, notification deadline
- ·Specific obligations of the importer: affixing contact details on the label, retaining the declaration of conformity
- 03
EUDAMED registration and UDI traceability (1 h)
- ·EUDAMED architecture: actors, UDI and certificates modules
- ·Registration obligations of the importer (contact details, deadlines)
- ·Verification of UDI registration by the manufacturer and completion by the importer
- ·EUDAMED roll-out schedule and state of progress at the time of the training
- 04
Vigilance obligations and regulatory cooperation (1 h 30)
- ·Incidents and serious incidents within the meaning of the MDR: definitions and qualification criteria
- ·Obligations to report information to the manufacturer and, where applicable, to the ANSM
- ·Participation in the post-market surveillance (PMS) system: role of the importer and the distributor
- ·Management of product recalls: documentary obligations, deadlines, traceability
- ·Cooperation with the competent authorities during inspections
- 05
Structuring internal procedures and role-play (2 h)
- ·Practical workshop: drafting an incoming verification procedure template tailored to the participants' context
- ·Exercise on handling a case of non-conformity detected in stock
- ·Review of a simulated ANSM inspection scenario: which documents to produce, within what deadlines?
- ·Summary and individual action plan
Assessment of learning
Assessment methods
20-question QCM at the end of the day covering the regulatory obligations of Articles 13 and 14 of the MDR, the EUDAMED/UDI procedures and the vigilance processes. Practical role-play integrated into the last module (handling a non-conformity case).
Certificate
Certificate of attendance 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 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.
Materials provided
- ·Complete presentation material in PDF format
- ·Incoming verification procedure template (editable Word document)
- ·MDR compliance checklist for importers/distributors (Articles 13, 14 and MDCG 2021-27 guidance)
- ·Summary of EUDAMED obligations and updated UDI schedule
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)
790 €
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.