MDR Technical Documentation — Building and Maintaining a Compliant File
The technical file is the cornerstone of a medical device's regulatory compliance. Required by Regulation (EU) 2017/745 for all device classes, it must be comprehensive from the moment the device is placed on the market and remain up to date throughout the product life cycle. This course gives regulatory affairs and design professionals the concrete tools to build, structure and maintain a technical file compliant with Annexes II and III of the MDR, meeting the expectations of notified bodies.
Audience Regulatory affairs managers and officers, design engineers, medical device project managers, and anyone involved in building or updating the technical documentation of a medical device.
Learning objectives
- ▸ Identify the regulatory structure of the technical file as defined by Annexes II and III of MDR 2017/745 and distinguish the elements required according to the device class
- ▸ Build the documentation relating to the general safety and performance requirements (GSPR — Annex I) by linking each requirement to the corresponding documented evidence
- ▸ Construct the documentary framework of the technical file: device description, design specifications, manufacturing information, clinical evaluation, risk management, labelling and instructions for use
- ▸ Integrate post-market surveillance requirements (PMS, PSUR, SSCP) into the technical documentation maintained after the device is placed on the market
- ▸ Organise the documentary management of the file to ensure its traceability, accessibility and continuous updating throughout the product life cycle
- ▸ Anticipate points of vigilance during a notified body review and prepare responses to requests for additional information
Expected outcomes
- ✓ Independent structuring of an MDR-compliant technical file for a class IIa or IIb device
- ✓ Identification of gaps in an existing file
- ✓ Management of a documentation update following a product or regulatory change
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 prerequisites. A general knowledge of the MDR 2017/745 framework is an asset. Participants seeking a foundational grounding are encouraged to first attend the IA-REG-01 course (MDR Fundamentals).
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 is not eligible for funding through 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
Regulatory framework of the MDR technical file (1 h 30)
- ·Recap of the manufacturer's obligations under MDR 2017/745
- ·Structure and logic of Annexes II and III
- ·Articulation with Annex I (GSPR) and other cross-cutting requirements
- ·Positioning of the technical file within the conformity assessment process according to the device class
- 02
Building the technical file: the mandatory documentary blocks (3 h)
- ·Device description and identification
- ·Supplier and manufacturing information
- ·Design and manufacturing specifications
- ·Information relating to labelling and instructions for use (IFU)
- ·Applicable harmonised standards and common specifications
- ·Practical workshop: building an annotated table of contents on a running case study
- 03
GSPR and traceability of evidence (1 h 30)
- ·Method for completing the GSPR checklist
- ·Link between each performance and safety requirement and the documented evidence (tests, standards, evaluations)
- ·Management of non-applicable requirements and justifications
- ·Exercise: complete a partial GSPR matrix on the running case study
- 04
Clinical evaluation, risk management and associated documentation (1 h 30)
- ·Role of the clinical evaluation report (CER) and the clinical evaluation plan (CEP) in the file
- ·Articulation with the risk management file (ISO 14971)
- ·Principles of post-market clinical follow-up (PMCF) and its documentary integration
- 05
Maintaining the technical file over time (2 h)
- ·Update triggers: product changes, standard developments, vigilance reports
- ·Change management process and impact on the technical documentation
- ·Post-market surveillance requirements: PSUR, SSCP, PMS report
- ·Documentary management: versioning, archiving, accessibility for the notified body
- ·Synthesis workshop: peer cross-audit on a deliberately incomplete file
- 06
Final review and assessment of learning (30 min)
- ·Consolidated questions and answers
- ·End-of-course QCM
Assessment of learning
Assessment methods
End-of-course QCM (20 questions covering modules 1 to 5). Continuous formative assessment through the practical workshops integrated into modules 2, 3 and 5. QCM results are communicated individually at the end of the session.
Certificate
Certificate of completion issued by Isofac Group at the end of the course, subject to full participation in all modules. 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
- ·Annotated extracts from Annexes II and III of the MDR
- ·Blank GSPR grid
- ·Technical file table of contents template
- ·Printed running case study for the practical workshops
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)
1 150 €
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 is not eligible for funding through 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.