Clinical Evaluation Report — Writing and maintaining an MDR-compliant CER
The clinical evaluation report is one of the documents most closely scrutinized by notified bodies under MDR 2017/745. Poorly structured, insufficiently substantiated or not kept up to date, it becomes a major bottleneck for CE marking. This training provides regulatory and clinical affairs professionals with the methods, documentary references and writing reflexes needed to produce a compliant, defensible and evolving CER.
Audience Regulatory affairs officers, clinical affairs managers, RA/clinical affairs project managers, R&D engineers involved in technical documentation.
Learning objectives
- ▸ Identify the regulatory requirements applicable to the CER (Article 61, Annex XIV of the MDR, MEDDEV 2.7/1 rev. 4, MDCG 2020-5, 2020-6, 2020-13 guidance documents) and distinguish the obligations according to the device class
- ▸ Structure a CER in line with notified bodies' expectations: standard outline, mandatory sections, hierarchy of clinical evidence
- ▸ Build and document a rigorous literature search strategy (PICO, databases, inclusion and exclusion criteria, synthesis and quality assessment of sources)
- ▸ Write the analytical sections of the CER: demonstration of conformity with the GSPR, benefit-risk analysis, justification of clinical equivalence where applicable
- ▸ Link the CER with the other documents of the technical dossier (risk management, IFU, PSUR, PMCF plan)
- ▸ Plan and implement the periodic update of the CER in connection with post-market data
Expected outcomes
- ✓ An annotated CER outline template
- ✓ A clinical data quality assessment grid
- ✓ The ability to defend the structure of one's report before an auditor or a notified body
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 MDR 2017/745 recommended. Initial experience in regulatory affairs or medical device technical documentation is an asset. The IA-REG-03 training (Technical documentation and design dossier) is a suggested prerequisite for beginner profiles.
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
Regulatory framework and documentary requirements of the CER (2 h)
- ·Obligations arising from Article 61 and Annex XIV of the MDR
- ·Hierarchy of reference texts: MEDDEV 2.7/1 rev. 4, MDCG 2020-5, 2020-6, 2020-13 guidance documents
- ·Scope of the CER according to the class and intended purpose of the device
- ·Place of the CER in the overall technical dossier
- 02
Structure and standard outline of the CER (2 h)
- ·Mandatory and recommended sections
- ·Device description and intended purpose
- ·Identification and qualification of clinical evaluators (competence requirements under MEDDEV and MDR)
- ·Practical exercise: critical analysis of two CER structures (compliant and non-compliant cases)
- 03
Search strategy and evaluation of clinical data (3 h)
- ·PICO method
- ·Selection of databases (PubMed, Embase, Cochrane, study registries)
- ·Inclusion and exclusion criteria, quality assessment grid
- ·Data from clinical equivalence: conditions and limits under the MDR
- ·Manufacturer's own data (preclinical data, post-market feedback, clinical investigations)
- ·Practical exercise: building a search strategy on a sample device
- 04
Writing the analytical sections of the CER (3 h)
- ·Synthesis of data: evidence tables, scientific argumentation
- ·Demonstration of conformity with the General Safety and Performance Requirements (GSPR)
- ·Benefit-risk analysis and clinical conclusion
- ·Practical exercise: guided writing of an analytical section from a provided data set
- 05
Linking with the technical dossier and life-cycle management (2 h)
- ·Consistency between CER / risk management ISO 14971 / IFU / labeling
- ·Link with the PSUR and the PMCF report
- ·Triggers for updating the CER: new data, incidents, revision of standards
- ·Document management and version traceability
- 06
Notified bodies' expectations and feedback from experience (2 h)
- ·Main reasons for rejection or requests for additional information on the CER
- ·Points of vigilance identified in MDCG reviews and notified bodies' reports
- ·Trainer's feedback from real (anonymized) situations
- ·Question-and-answer session and summary of the training
Assessment of learning
Assessment methods
20-question QCM at the end of the training covering regulatory requirements, the structure of the CER and clinical research methodology, supplemented by a practical scenario: participants write an analytical summary from a fictitious clinical data set, assessed on the basis of a criteria-based grid.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full attendance over both days. 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.
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.