CE Marking under MDR — From the technical file to market placement
Master the entire CE pathway — from device classification to the declaration of conformity — to lead your market-placement projects with full regulatory autonomy.
Audience Regulatory affairs managers and officers, product managers, quality managers involved in CE marking projects, staff interfacing with a notified body.
Learning objectives
- ▸ Classify a medical device according to the rules of Annex VIII of MDR 2017/745 and select the conformity assessment procedure suited to its risk class
- ▸ Structure a technical file compliant with the requirements of Annexes II and III of the MDR, incorporating evidence of fulfilment of the GSPR (General Safety and Performance Requirements)
- ▸ Prepare and draft the EU declaration of conformity and the elements required for EUDAMED registration
- ▸ Identify the obligations applicable at market placement: appointment of the PRRC, labelling, UDI assignment, economic operator registration
- ▸ Organise interactions with a notified body: select the competent NB, prepare file reviews and anticipate requests for additional information
- ▸ Distinguish the post-market surveillance requirements (PSUR, PMCF, SSCP) that condition the maintenance of CE marking after market placement
Expected outcomes
- ✓ On completion of the training, the participant independently leads a CE marking project for a class IIa/IIb medical device scope, builds a structured technical file and handles regulatory interactions with internal and external stakeholders.
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
General knowledge of MDR 2017/745 recommended. The IA-REG-02 training (Manufacturer's obligations under MDR) or IA-REG-03 (MDR technical documentation) provides optimal preparation, though it is 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 OPCO funding
- ·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 foundations and scope of the MDR (1 h 30)
- ·Scope of Regulation 2017/745
- ·Definition and boundaries of the medical device
- ·Logic of the risk classes (I, IIa, IIb, III) and classification rules of Annex VIII
- ·Conformity assessment procedures by class: class I self-certification, notified body involvement for higher classes
- 02
Building the technical file (3 h)
- ·Architecture of the technical file according to Annexes II and III of the MDR
- ·Demonstration of conformity to the GSPR: application of harmonised standards and common specifications
- ·Risk management according to ISO 14971: integration into the technical file
- ·Clinical evaluation (plan, report, reference to Annex XIV): articulation with the file
- ·Case studies on documentary structuring
- 03
Declaration of conformity and EUDAMED registration (1 h 30)
- ·Content and responsibilities attached to the EU declaration of conformity
- ·EUDAMED registration process: manufacturer profile, medical device registration, certificate status
- ·UDI (Unique Device Identification) assignment: UDI-DI / UDI-PI logic, EUDAMED database
- 04
Obligations at market placement (2 h)
- ·Appointment and role of the PRRC (Person Responsible for Regulatory Compliance)
- ·Labelling under MDR: requirements of Annex I and use of harmonised symbols
- ·Instructions for use (IFU): substantive and formal requirements
- ·Obligations of importers, distributors and authorised representatives
- 05
Interactions with the notified body (2 h)
- ·Criteria for selecting an MDR-designated notified body
- ·Phases of conformity assessment: application review, documentary examination, QMS audit
- ·Anticipating requests for additional information and managing non-conformities raised by the NB
- ·Managing the CE certificate life cycle: surveillance, renewal, modifications
- 06
Maintaining CE marking and post-market surveillance (2 h)
- ·Continuing obligations of the manufacturer after market placement
- ·PSUR (Periodic Safety Update Report) and SSCP (Summary of Safety and Clinical Performance) according to the device class
- ·PMCF (Post-Market Clinical Follow-up) plan
- ·Vigilance and reporting of serious incidents to the ANSM
- ·Summary and final consolidation quiz
Assessment of learning
Assessment methods
20-question multiple-choice QCM at the end of the training (Day 2), covering all modules. Practical exercise on structuring a simplified technical file based on a fictitious case, corrected as a group.
Certificate
Training certificate issued by Isofac Group upon completion of the training, subject to full participation in both days. This certificate does not constitute a certification recognised by the RNCP or the Specific Directory (RS). It attests to participation and to the assessment of learning outcomes carried out at the end of the session.
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
- ·Extracts from MDR 2017/745 (Annexes I, II, III, VIII, XIV)
- ·Declaration of conformity templates
- ·GSPR grid
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 OPCO funding
- ·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.