Regulation (EU) 2017/745 — Fundamentals and scope
Regulation (EU) 2017/745 has profoundly reshaped the rules of the game for all stakeholders in the medical device chain. Manufacturers, authorised representatives, importers, distributors: each must master what the MDR requires of them, from the very first hour. This day provides the essential bearings, without detours.
Audience Any professional operating within the medical device ecosystem — regulatory affairs, quality assurance, R&D, purchasing, production, general management — with no prior regulatory prerequisites.
Learning objectives
- ▸ Position Regulation (EU) 2017/745 within the European regulatory landscape and identify the applicable related texts (delegated regulations, MDCG guidances, harmonised standards)
- ▸ Delineate the scope of the MDR and distinguish products falling under the regulation from those subject to other frameworks (IVDR, medicinal products, PPE)
- ▸ Apply the classification rules for medical devices (Annex VIII) and derive the corresponding conformity assessment procedures
- ▸ Identify the economic operator statuses defined by the MDR (manufacturer, authorised representative, importer, distributor) and describe the obligations associated with each
- ▸ Recognise the general safety and performance requirements (GSPR, Annex I) as the foundation of product compliance
- ▸ Identify the main traceability and transparency mechanisms introduced by the MDR (UDI, EUDAMED) and understand their practical implications
Expected outcomes
- ✓ By the end of the day, each participant has a structured mental map of the MDR and knows how to position their scope of responsibility within the regulatory framework in force.
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
No formal regulatory prerequisites. Professional experience in the medical device or life sciences sector is an asset, not an obligation.
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 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.
- 01
Genesis and architecture of the MDR (1 h)
- ·European regulatory context
- ·Transition from Directives 93/42/EEC and 90/385/EEC to Regulation 2017/745; main innovations of the MDR
- ·Articulation with the IVDR 2017/746
- ·Application timeline and transitional provisions (Regulation (EU) 2023/607)
- 02
Scope and key definitions (1 h)
- ·Definition of a medical device under the MDR
- ·Annex XVI — products without a medical purpose
- ·Regulatory boundaries with medicinal products, PPE and IVDs
- ·Combination rules for device / medicinal product
- 03
Classification of medical devices (1 h 30)
- ·Classification rules (Annex VIII)
- ·Classes I, IIa, IIb, III; specificities of active implantable medical devices
- ·Conformity assessment procedures associated with each class
- ·Role of the notified body
- 04
Economic operators and responsibilities (1 h)
- ·Manufacturer, authorised representative, importer, distributor: definitions, obligations and respective responsibilities
- ·Concept of PRRC (Person Responsible for Regulatory Compliance, Article 15 MDR)
- ·Traceability of obligations across the supply chain
- 05
General safety and performance requirements (1 h)
- ·Structure of Annex I (GSPR)
- ·Benefit / risk ratio
- ·General requirements, requirements regarding design and manufacture
- ·Documentation of compliance with the GSPR
- 06
Traceability, transparency and EUDAMED (1 h)
- ·UDI system (Unique Device Identification): structure, levels, registration obligations
- ·EUDAMED: European database, modules, deployment timeline
- ·Practical implications for manufacturers and economic operators
- 07
Synthesis, questions and individual action plan (30 min)
- ·Consolidation of knowledge and individual regulatory mapping
- ·Positioning of each participant's scope of responsibility
- ·Questions / answers with the trainer
Assessment of learning
Assessment methods
QCM of 20 questions administered at the end of the day, covering all modules. Pass threshold: 60%. Results communicated individually at the end of the session.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full attendance for the day. This certificate attests to participation and knowledge assessment within the framework of this training action; it 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.
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 eligible for funding 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.