Clinical investigation — Regulatory framework, study design and conduct according to ISO 14155:2020
Designing a clinical investigation compliant with MDR 2017/745 and ISO 14155:2020 requires simultaneously mastering European regulation, the normative requirements of good clinical practice and the constraints of the French national framework. This two-day training offers a progressive skills development: from the regulatory positioning of the clinical investigation within the demonstration of conformity, through to the drafting of the protocol and the operational conduct of the study.
Audience Clinical affairs officers, investigators, regulatory affairs managers, R&D project managers, and personnel in charge of clinical evaluation.
Learning objectives
- ▸ Position the clinical investigation within the MDR 2017/745 regulatory pathway and identify the situations requiring its implementation (Annexes XIV and XV)
- ▸ Apply the requirements of ISO 14155:2020 to the design, conduct and reporting of a clinical investigation on human subjects
- ▸ Structure a Clinical Investigation Plan (CIP) compliant with the normative requirements and the recommendations of the MDCG 2024-3 guidance
- ▸ Identify the national regulatory steps: ANSM submission, opinion of the Personal Protection Committee (CPP), EUDAMED registration
- ▸ Define the respective responsibilities of the sponsor and the principal investigator and put in place the required monitoring and reporting mechanisms
- ▸ Articulate pre-market clinical investigation and PMCF studies within the continuous clinical evaluation strategy
Expected outcomes
- ✓ Upon completion of the training, participants have the methodological tools to initiate the assembly of a clinical investigation file, draft the key sections of the CIP, and steer interactions with the competent authorities.
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 medical device regulation (MDR 2017/745) and clinical evaluation recommended. The IA-REG-01 training (MDR Fundamentals) or equivalent 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 training is not Qualiopi-certified and is not fundable 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
The clinical investigation within the MDR 2017/745 framework (2 h)
- ·Definition and purpose of the clinical investigation; place in the demonstration of conformity with the GSPR (Annex I)
- ·Articulation with clinical evaluation (Annex XIV) and the requirements specific to investigation (Annex XV)
- ·Situations where investigation is mandatory, optional or excluded
- ·Overview of French national regulation: Jardé law, role of the ANSM and the CPPs
- 02
ISO 14155:2020: structure and good clinical practice requirements (2 h 30)
- ·Architecture of the standard and articulation with the MDR / IVDR
- ·Fundamental ethical principles: respect for the rights, safety and well-being of subjects
- ·Responsibilities of the sponsor and the principal investigator; management of informed consent
- ·Reporting of adverse events
- ·Comparison with the drug approach (ICH-GCP E6): medical device specificities
- 03
Design and assembly of the clinical investigation protocol (3 h)
- ·Structure and content of the Clinical Investigation Plan (CIP) according to ISO 14155:2020 and the MDCG 2024-3 guidance
- ·Definition of primary and secondary objectives; inclusion/exclusion criteria and target population
- ·Statistical plan and calculation of the number of subjects required (principles)
- ·Data management, monitoring and audit trail
- ·Practical workshop: partial construction of a CIP on a fictitious case
- 04
Regulatory submissions and interactions with the authorities (2 h)
- ·ANSM notification procedure and timelines
- ·Compilation of the CPP opinion request file
- ·Registration of the investigation in EUDAMED
- ·Management of substantial modifications; specificities of emergency investigations
- 05
Conduct of the study and closure (2 h)
- ·Setting up the investigator sites
- ·Clinical monitoring: monitoring plan, site visits, management of protocol deviations
- ·Clinical investigation report (CIR)
- ·Transition to post-market clinical follow-up (PMCF)
- ·Integration of data into the PSUR and the SSCP (summary of safety and clinical performance)
- 06
Synthesis, practical cases and questions and answers (2 h 30)
- ·Feedback on the practical cases from the previous modules
- ·Questions arising from the participants' professional situations
- ·Frequent points of vigilance noted by notified bodies and the ANSM
Assessment of learning
Assessment methods
End-of-training QCM covering the key concepts of the modules, supplemented by a role-play on a fictitious case in subgroups (partial structuring of a CIP).
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 recognized by the RNCP or the Specific Register (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
- ·Teaching materials in PDF format
- ·Reference regulatory extracts: MDR Annexes XIV and XV, extracts from ISO 14155:2020, MDCG 2024-3 guidance
- ·Reusable CIP template, provided during the workshop
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)
1 590 €
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 fundable 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.