Unique Device Identification (UDI) — Compliance and implementation
Audience Regulatory affairs, supply chain
Learning objectives
- ▸ Describe the UDI system: structure, components (UDI-DI and UDI-PI) and issuing entities
- ▸ Identify the applicable UDI labelling obligations according to the device class and the MDR timeline
- ▸ Register a medical device in EUDAMED in compliance with the database requirements
- ▸ Set up an internal process for managing and transmitting the UDI throughout the distribution chain
Expected outcomes
By the end of the course, participants can apply the requirements of the standard/regulation covered to their own cases and defend their choices in an audit.
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 recommended (IA-REG-01 or equivalent experience).
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
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
Fundamentals of the UDI system (1h30)
- ·Objectives of the UDI system and global regulatory context
- ·UDI structure: UDI-DI, UDI-PI, data carrier (GS1, HIBCC, ICCBBA)
- ·Implementation timeline by device class
- 02
Labelling obligations (2h)
- ·Rules for applying the UDI on the label and packaging
- ·Requirements for implantable devices: enhanced traceability
- ·Exceptions and special cases (reprocessed devices, systems and procedure packs)
- 03
EUDAMED — European database (2h)
- ·EUDAMED architecture: modules and functionalities
- ·Registration of actors and devices
- ·Update obligations and deadlines
- 04
Operational implementation (1h30)
- ·Internal process for assigning and managing the UDI
- ·UDI integration into the information system (ERP, PLM)
- ·Practical exercise: EUDAMED registration simulation
Assessment of learning
Assessment methods
QCM of 20 questions (60% minimum). EUDAMED simulation practical exercise. ISOFAC Group certificate (Qualiopi).
Certificate
A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.
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)
790 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Personalised quote and OPCO funding application prepared 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.