IA-REG-05 1 day (7h) · Virtual classroom

Regulatory responsibilities according to your role — Manufacturer, authorised representative, importer, distributor

Do you operate in the medical device distribution chain and wonder what exactly MDR 2017/745 expects from you, depending on the role you occupy? This day gives you a clear mapping, role by role, of the legal obligations and practical points of vigilance. A fundamental for any economic operator who cannot afford to confuse their responsibilities with those of the next link in the chain.

Audience Regulatory affairs managers, quality managers, supply chain managers, general managers, import-export managers, RA assistants — within companies that are manufacturers, authorised representatives (EU authorised representatives), importers or distributors of medical devices.

Learning objectives

  • ▸ Distinguish the regulatory definitions of the manufacturer, the authorised representative, the importer and the distributor as established by articles 2, 11, 13 and 14 of MDR 2017/745
  • ▸ Identify the obligations specific to each role (EUDAMED registration, UDI, labelling, vigilance, document retention) and the applicable penalties in the event of non-compliance
  • ▸ Analyse dual-role situations (importer also authorised representative, manufacturer also distributor) and determine the prevailing status in accordance with the MDCG 2021-27 guidance
  • ▸ Build an internal compliance matrix associating each MDR obligation with the role exercised within your own organisation
  • ▸ Formulate the minimum contractual requirements to be included in agreements with the other economic operators in the chain
  • ▸ Implement the first corrective or preventive actions to align existing practices with the requirements of the regulation

Expected outcomes

  • ✓ Participants leave with an operational understanding of their own regulatory scope, a reading grid of the responsibilities of their chain partners, and the basics to document the compliance of their role in the context of an ANSM audit or inspection.

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 environment for medical devices recommended. It is advisable to have previously taken IA-REG-01 (MDR Fundamentals) or to have professional experience in the sector.

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.

  1. 01

    Regulatory framework and mapping of operators (1 h)

    • ·Review of applicable texts (MDR 2017/745, MDCG guidance)
    • ·Legal definitions: manufacturer, authorised representative, importer, distributor
    • ·Presentation of the economic chain and the interactions between roles
    • ·Case of dual roles and complex chains
  2. 02

    Obligations of the manufacturer (1 h 30)

    • ·Quality management system (art. 10)
    • ·Technical file and documentation
    • ·EU declaration of conformity
    • ·PRRC (Person Responsible for Regulatory Compliance)
    • ·EUDAMED registration and UDI assignment
    • ·Post-market surveillance and vigilance
  3. 03

    Role and obligations of the authorised representative (1 h)

    • ·Conditions of designation (non-EU manufacturer)
    • ·Scope of the mandate: what the authorised representative can and cannot do
    • ·Own obligations versus delegated obligations
    • ·EUDAMED registration in priority over the non-EU manufacturer
    • ·Termination of the mandate and notification to the authorities
  4. 04

    Role and obligations of the importer (1 h)

    • ·Checks on entry to the EU market (CE marking, UDI, instructions for use, designated authorised representative)
    • ·Labelling obligations for contact details
    • ·Refusal of importation and reporting to the authorities
    • ·Traceability and document retention (art. 13)
  5. 05

    Role and obligations of the distributor (1 h)

    • ·Checks before making available (art. 14)
    • ·Obligations to report non-conformities and incidents
    • ·Distinction between placing on the market and making available
    • ·Articulation with downstream vigilance
  6. 06

    Role-play and practical cases (1 h 30)

    • ·Workshops: mapping the obligations specific to each participant according to their actual role
    • ·Analysis of concrete cases of non-compliance (missing UDI, undesignated authorised representative, missing importer labelling)
    • ·Building a personalised compliance matrix
    • ·Questions and answers

Assessment of learning

Assessment methods

20-question QCM administered at the end of the day via the virtual classroom platform, covering all the modules. Results communicated individually.

Certificate

Training certificate issued by Isofac Group at the end of the training, subject to full participation in the session. This document 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

  • ·Annotated slideshow
  • ·Blank compliance matrix per role, to be completed during the workshops
  • ·Summary of the MDR articles applicable to economic operators
  • ·References to the MDCG 2021-27 guidance

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 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.

Register → ← Back to catalogue