AI in medical devices — European Regulation on Artificial Intelligence (AI Act) and medical devices
Medical devices integrating artificial intelligence are now subject to a dual regulatory framework: MDR 2017/745 and Regulation (EU) 2024/1689 on artificial intelligence (AI Act). This accumulation of requirements generates concrete areas of uncertainty for R&D, regulatory affairs and digital management teams: qualification of AI systems, risk classification, additional documentary obligations, post-market surveillance. This one-day training provides an operational, cross-cutting reading of the two regulations, clear reference points on the phased application deadlines, and tools that are directly transposable in an industrial context.
Audience R&D managers, regulatory affairs engineers, digital or innovation directors and managers within companies manufacturing or developing medical devices that integrate AI components or software based on machine-learning algorithms.
Learning objectives
- ▸ Identify the scope of application of Regulation (EU) 2024/1689 (AI Act) and qualify AI systems integrated into a medical device with regard to the risk categories defined by the text
- ▸ Analyse the regulatory interactions between the AI Act and MDR 2017/745, in particular on technical documentation, risk management (ISO 14971) and post-market surveillance (PMS/PMCF)
- ▸ Assess the impact of the AI Act on the company's existing QMS and identify the priority adaptations to be carried out
- ▸ Distinguish the obligations incumbent on providers of general-purpose AI systems (GPAI) from those borne by manufacturers of medical devices integrating these systems
- ▸ Plan documentary compliance actions taking into account the regulation's phased application timeline (2024-2027)
- ▸ Apply a regulatory impact analysis grid to a concrete case of a medical device integrating an AI feature
Expected outcomes
- ✓ On completion of the training, participants have a mapping of the cross-cutting AI Act / MDR obligations, an impact analysis method applicable to their product range, and a prioritised documentary checklist.
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 Regulation (EU) 2017/745 (MDR) and its scope of application. Experience in regulatory affairs, medical device R&D or industrial quality is recommended. No prior knowledge of IT or data science is required.
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 framing: the AI Act in the European medical device landscape (1h30)
- ·Origins and objectives of Regulation (EU) 2024/1689; structure of the text and risk-based approach
- ·Phased entry-into-application timeline (2024-2027) and immediate points of vigilance
- ·Articulation with MDR 2017/745, IVDR 2017/746 and the NIS2 directive
- ·Concepts of AI system, general-purpose AI model (GPAI) and AI embedded in a medical device
- 02
Classification and qualification of high-risk AI systems (1h30)
- ·Definition of the AI Act risk categories
- ·Why medical devices falling under the MDR are systematically classified as high-risk
- ·Qualification criteria: when does a medical device algorithm fall under the AI Act?
- ·Special cases: diagnostic-support AI, predictive AI, continuous-learning algorithms
- ·Interactions with the MDR classification rules and the GSPR
- 03
Documentary obligations and QMS: what concretely changes (2h)
- ·Additional technical requirements: instructions for use, information sheet, AI risk management system
- ·Impact on the MDR technical file (Annexes II and III): sections to create or adapt
- ·Traceability requirements for training and validation data
- ·Post-market surveillance obligations specific to AI
- ·Adaptation of the ISO 13485 QMS: which processes to revise as a priority?
- ·Practical exercise: documentary impact analysis on a fictitious case of a medical device integrating an automated detection feature
- 04
Operator obligations and internal governance (1h)
- ·Responsibilities of the AI system provider and the integrating manufacturer; role of the deployer
- ·Transparency obligations towards users and patients
- ·Points of contact with the PRRC (Person Responsible for Regulatory Compliance)
- ·Corrective measures and notification of AI incidents
- 05
Compliance: method and prioritisation (1h)
- ·Cross-cutting AI Act / MDR regulatory impact analysis grid
- ·Typical compliance roadmap
- ·AI regulatory maturity indicators to deploy within the company
- ·Questions and answers and operational summary
Assessment of learning
Assessment methods
End-of-day QCM (15 to 20 questions covering modules 1 to 5) and a practical regulatory impact analysis exercise carried out in groups during module 3. Both elements are subject to individualised feedback from the trainer.
Certificate
Training certificate issued by ISOFAC Group at the end of the session, subject to full attendance for 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
- ·Course materials in PDF format (provided before the session)
- ·Cross-cutting AI Act / MDR regulatory impact analysis grid used in the exercise
- ·List of reference regulatory resources: official texts, MDCG guidance, European Commission FAQs
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)
890 €
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.