Drug-device combination products — Mastering the requirements of MDR Article 117
Does your product integrate both a medicinal substance and a medical device in a single unit? Article 117 of Regulation (EU) 2017/745 profoundly changes the documentary obligations applicable to the device component, and places a new responsibility on pharmaceutical companies applying for marketing authorisation. This one-day course provides you with the regulatory and documentary tools to manage the compliance of the "device" part of your combination product, prepare the interaction with the notified body and secure your market access dossier.
Audience Regulatory affairs (RA) managers and officers, pharmaceutical affairs managers, combination product development project managers, quality managers at the pharma/medical device interface.
Learning objectives
- ▸ Identify the categories of combination products subject to MDR Article 117 and distinguish between "primary medicinal product" versus "primary device" qualification cases
- ▸ Analyse the documentary requirements imposed by Article 117 for the device component in the marketing authorisation dossier (conformity assessment results or notified body opinion)
- ▸ Build the regulatory strategy suited to their combination product based on the device classification and the need (or not) for a notified body
- ▸ Prepare the technical documentation of the device component in line with the GSPRs of MDR Annex I
- ▸ Anticipate notified body requirements in the Article 117 opinion procedure and structure the interaction with them
- ▸ Incorporate the latest EMA guidance and the COMBO programme into the lifecycle management of combination products
Expected outcomes
- ✓ Assess the documentary compliance of the device component of their combination product
- ✓ Prepare or supervise the compilation of the technical documentation required by Article 117
- ✓ Initiate the notified body procedure in a structured manner
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 European regulatory framework for medical devices (MDR 2017/745) or pharmaceutical regulatory affairs (Directive 2001/83/EC). The IA-REG-01 course (MDR Fundamentals) or professional experience in medical device RA or pharmaceutical affairs is a recommended prerequisite.
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 course is not Qualiopi-certified and cannot be funded via the OPCOs
- ·Self-funded or financed through 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
Scope and regulatory definitions (1 h)
- ·Definition of the integral combination product within the meaning of Article 1(8) and Article 117 of the MDR
- ·Distinction between integral drug-device combination, co-packaged and co-referenced products
- ·Qualification criterion of the principal mode of action
- ·Interplay between MDR 2017/745 and Directive 2001/83/EC
- ·Typological examples: prefilled auto-injectors, inhalers, integrated infusion pumps
- 02
Documentary requirements of Article 117 (1 h 30)
- ·Annotated reading of MDR Article 117
- ·The two documentary pathways: MDR conformity assessment results or notified body opinion
- ·Conditions triggering the notified body opinion obligation
- ·Content of the technical documentation of the device component: GSPRs (MDR Annex I), clinical evaluation, risk management (ISO 14971), drug/device compatibility
- ·Requirements of Directive 2001/83/EC for inclusion in the marketing authorisation dossier
- 03
Interaction with the notified body (1 h 30)
- ·Role of the notified body in the Article 117 procedure
- ·Team-NB position paper on documentary requirements
- ·Course of the notified body opinion procedure: steps, timelines, checkpoints
- ·Preparing the submission dossier: recommended structure, common pitfalls
- ·Management of non-conformities and requests for additional information
- ·Practical case: analysis of a technical documentation summary
- 04
Lifecycle management and post-authorisation issues (1 h)
- ·Changes to the combination product and impact on the Article 117 dossier
- ·Post-market surveillance of the device component
- ·Integrating the PSUR and PMCF into the combination products strategy
- ·Latest developments: EMA COMBO programme, 2025 guidance, MDR/IVDR revision outlook
- 05
Application workshop and Q&A (2 h)
- ·Analysis of practical cases provided by the trainer and/or drawn from participants' situations
- ·Building or revising an Article 117 compliance checklist
- ·Collective synthesis, open questions, individual points of attention
Assessment of learning
Assessment methods
End-of-day QCM (20 questions covering modules 1 to 4), administered online. A score of 70% is required for the certificate of completion to be issued.
Certificate
Certificate of completion issued by Isofac Group at the end of the course, subject to full attendance for the day and submission of the assessment QCM. 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.
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 course is not Qualiopi-certified and cannot be funded via the OPCOs
- ·Self-funded or financed through 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.