Clinical evaluation of medical devices — Choosing the right route and structuring your evaluation plan
Clinical evaluation is one of the cornerstones of the MDR technical file — and one of the most frequent sources of non-conformity flagged by notified bodies. This one-day course provides the keys to choosing the route suited to your device (literature, demonstration of equivalence, clinical investigation, or a combination), then building a structured Clinical Evaluation Plan (CEP) that complies with current regulatory expectations.
Audience Regulatory affairs managers, clinical affairs officers, and quality managers involved in building the MDR technical documentation.
Learning objectives
- ▸ Position clinical evaluation within the medical device life cycle and identify how it connects with risk management, PMCF, and post-market surveillance (PMS), in accordance with MDR 2017/745 and the applicable MDCG guidances
- ▸ Analyze a device's characteristics (class, intended medical purpose, existing data) to select the most appropriate clinical evaluation route and document the justification for the choice
- ▸ Build a complete and compliant Clinical Evaluation Plan (CEP) that incorporates the requirements of MDR Annex XIV and the recommendations of MEDDEV 2.7/1 rev. 4
- ▸ Identify the equivalence criteria (technical, biological, clinical) and the conditions for the admissibility of the demonstration of equivalence, including the restrictions introduced by the MDR regarding access to the reference device's data
- ▸ Articulate the CEP with the key documents of the technical file: GSPR, risk management report, PMCF plan, SSCP
- ▸ Identify the main causes of rejection or requests for additional information from notified bodies and adapt the strategy accordingly
Expected outcomes
- ✓ An annotated CEP template that can be reused directly in your professional context
- ✓ A decision-support grid for choosing the evaluation route
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 MDR 2017/745 regulation recommended. Experience in the regulatory or clinical affairs of medical devices makes the content easier to assimilate.
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 through 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 clinical evaluation (1 h)
- ·Requirements of MDR 2017/745 (Annex XIV)
- ·Relevant MDCG guidances (including MDCG 2020-6, MDCG 2020-13, MDCG 2021-6)
- ·Articulation with MEDDEV 2.7/1 revision 4
- ·The place of clinical evaluation in the technical documentation and CE marking procedures
- 02
Mapping the clinical evaluation routes (1 h 30)
- ·Clinical literature route: criteria for selecting and evaluating data, levels of evidence
- ·Demonstration of equivalence: tripartite criteria, MDR restrictions on access to a competitor device's data, practical cases
- ·Clinical investigation under ISO 14155: when is it mandatory?
- ·Combination of routes: rationale, conditions, documentation
- ·Decision grid and applied exercise on a field case
- 03
Structuring the Clinical Evaluation Plan (CEP) (2 h)
- ·Regulatory content expected in the CEP (Annex XIV, §1)
- ·Drafting the key sections: intended medical purpose and claims, scope of the evaluation, data sources, inclusion/exclusion criteria, description of the analysis methodology
- ·Link between the CEP and the clinical evaluation report (CER): consistency and updating
- ·Workshop: building a CEP on a representative fictional case
- 04
Integration into the MDR technical documentation (1 h)
- ·Articulation with the general safety and performance requirements (GSPR/Annex I)
- ·Articulation with the risk management report (ISO 14971), the PMCF plan (Annex XIV, §2), and the SSCP (Annex III)
- ·Notified bodies' expectations: field feedback
- 05
Summary, Q&A, and individual action plan (1 h 30)
- ·Recap of the critical points
- ·Review of the main requests for additional information issued by notified bodies
- ·Building an individual action plan: next operational steps for each participant
Assessment of learning
Assessment methods
End-of-day QCM (15 to 20 questions covering all the modules) supplemented by a role-play on a practical exercise carried out during the training (Module 3). Results are communicated individually.
Certificate
Certificate of training issued by Isofac Group upon completion of the training, subject to full attendance throughout the day. This certificate does not constitute a certification recognized 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 CEP template
- ·Decision-support grid for choosing the route
- ·Recap of the applicable MDCG guidances
- ·Selected regulatory bibliography
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 through 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.