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Clinical Evaluation Reports and PMCF under EU MDR Course & Certification
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Clinical Evaluation Reports and PMCF under EU MDR
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About
Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-up (PMCF) are essential components of the European Union Medical Device Regulation (EU MDR 2017/745), ensuring that medical devices demonstrate ongoing safety, clinical performance, and a favorable benefit-risk profile throughout their lifecycle. These processes help manufacturers systematically gather, appraise, analyze, and document clinical evidence while maintaining compliance with regulatory requirements and supporting continuous post-market surveillance.
This Clinical Evaluation Reports and PMCF under EU MDR Training Course & Certification provides comprehensive knowledge of MDR clinical evaluation requirements, Article 61 obligations, Annex XIV Parts A and B, Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), clinical evidence appraisal, state-of-the-art analysis, equivalence assessments, benefit-risk evaluation, PMCF planning and execution, PMCF Evaluation Reports, PMS integration, PSUR requirements, and notified body expectations. Upon successful completion, learners receive a certification demonstrating their understanding of CER and PMCF processes under the EU MDR framework.
Who Should Enrol?
- Medical Device Regulatory Affairs Professionals
- Clinical Affairs and Clinical Evaluation Specialists
- Quality Assurance and Quality Management Professionals
- Post-Market Surveillance (PMS) and Vigilance Personnel
- Medical Device Manufacturers and Product Development Teams
- Clinical Research and PMCF Professionals
- Regulatory Compliance and Risk Management Personnel
- Anyone involved in EU MDR clinical evidence generation, evaluation, and compliance
What you will learn
Understand the principles of Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-up (PMCF) under the EU Medical Device Regulation (EU MDR), including the regulatory requirements for demonstrating device safety, performance, and clinical benefit.
Learn the roles of clinical evaluation, clinical evidence, state-of-the-art analysis, equivalence, benefit-risk assessment, and post-market surveillance in supporting MDR compliance.
Develop knowledge of equivalence assessments, state-of-the-art analysis, Clinical Evaluation Plans (CEP), PMCF Plans, and PMCF Evaluation Reports.
Gain understanding of the integration of CER, PMCF, PMS, PSUR, and risk management activities to support ongoing MDR compliance throughout the device lifecycle.
Course Syllabus
- Why clinical evaluation and PMCF are a continuous lifecycle, not one-off documents
- The six clinical-evidence discipline rules the course will not bend
- Clinical evaluation, clinical investigation, PMCF and PMS - told apart
- The MDR is law; the MDCG documents are guidance; ISO 14155/14971 are standards; the ISO/TRs are technical reports; MEDDEV 2.7/1 Rev 4 is pre-MDR background
- The RhythmWatch Pro case study (fictional) and the scenarios CS-01 to CS-08
- The 20 templates and the Clinical Evaluation Report you build towards
- Assessment, pass mark, certificate and its limits
- Clinical evaluation as a continuous lifecycle process under the MDR
- Article 61 and Annex XIV Part A: what the regulation requires
- Clinical data versus clinical evidence - the distinction that runs through the course
- Clinical evaluation, clinical investigation, PMCF and PMS - four different things
- GSPRs (Annex I), the risk framework and where clinical evidence sits
- The MDCG guidance landscape and the pre-MDR status of MEDDEV 2.7/1 Rev 4
- RhythmWatch Pro: the device, its components and its clinical-evidence challenge
- Developing a Clinical Evaluation Plan under Annex XIV Part A
- Defining intended purpose, population, indications and contraindications
- Writing clinical claims - safety, performance and benefit
- The Clinical Claims Register: tracing every claim to evidence
- Mapping clinical evidence to the general safety and performance requirements
- The GSPR Clinical Evidence Matrix as the spine of the CER
- RhythmWatch Pro CS-01: the CEP and clinical claims
- Defining state of the art and benefit-risk benchmarks before analysis
- The State-of-the-Art Framework: current care, alternatives and comparable devices
- Developing a reproducible literature-search protocol with PICO
- Search strategy, databases and documented search strings
- Screening, classifying and documenting literature (PRISMA-style)
- Why literature volume is not clinical evidence
- RhythmWatch Pro CS-02: the state-of-the-art analysis and the search
- Appraising relevance, methodological quality and scientific validity
- Turning clinical data into clinical evidence through appraisal
- The Clinical Data Extraction Table and the Appraisal Tool
- Identifying and evaluating manufacturer-held clinical data
- Analysing appraised data against the device, population and claims
- Common failures: volume mistaken for evidence, data mistaken for evidence
- RhythmWatch Pro CS-03: appraising the manufacturer-held data
- Equivalence across technical, biological and clinical characteristics
- Why a shared product code or intended purpose does not confer equivalence
- The equivalence restrictions and the data-access requirements (MDCG 2020-5)
- Determining whether clinical evidence is sufficient (MDCG 2020-6)
- The Sufficient Clinical Evidence Gap Assessment
- Identifying gaps and when a clinical investigation may be required
- RhythmWatch Pro CS-04 and CS-05: equivalence and the gap assessment
- Writing a structured CER to the assessed structure (MDCG 2020-13)
- Integrating risk, PMS, vigilance, complaints and PMCF evidence
- Stating benefit-risk and GSPR conformity conclusions
- Recording residual gaps and the PMCF that will address them
- What a notified body assesses - the CEAR perspective
- Common CER failures and how to avoid them
- RhythmWatch Pro CS-06: assembling the CER
- Developing a proportionate PMCF strategy (Annex XIV Part B)
- The PMCF Decision Tree: whether, and what, PMCF is required
- Selecting general and specific PMCF methods
- Writing the PMCF Plan to the MDCG 2020-7 structure
- The PMCF Data Collection Plan: objectives into executable data
- Why PMCF is not optional because a device is long-established
- RhythmWatch Pro CS-07: PMCF strategy, plan and methods
- Writing the PMCF Evaluation Report to the MDCG 2020-8 structure
- Feeding PMCF results back into the CER and benefit-risk
- Connecting PMCF to the CER, risk, PMS/PSUR and the SSCP
- The PMS-CER-Risk-PSUR cross-reference and lifecycle integration
- Establishing update triggers and frequencies by risk class
- Responding to notified-body clinical and PMCF deficiencies
- RhythmWatch Pro CS-08: PMCF reporting and deficiency response
- The six discipline rules, revisited
- The clinical-evaluation and PMCF lifecycle in one page
- The 20 templates and how to deploy them
- Common CER and PMCF failures, and how to avoid them
- Building your own clinical-evaluation and PMCF programme
- Final assessment and 80% pass mark
- Certificate of completion and its scope
- 📘 Bonus: Clinical Evaluation Reports and PMCF under EU MDR eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with the current sources for clinical evaluation and PMCF under the EU MDR: Regulation (EU) 2017/745 (the MDR) - clinical evaluation under Article 61 and Annex XIV Part A, PMCF under Annex XIV Part B, PMS under Articles 83-86, the PSUR under Article 86, the SSCP under Article 32 and the GSPRs of Annex I; the MDCG guidance - MDCG 2020-5 (equivalence), MDCG 2020-6 (sufficient clinical evidence for legacy devices), MDCG 2020-7 (PMCF Plan), MDCG 2020-8 (PMCF Evaluation Report), MDCG 2020-13 (the CEAR template notified bodies use), MDCG 2022-21 (PSUR) and MDCG 2025-10, the post-market surveillance system guidance published on 19 December 2025; ISO 14155:2020 for clinical investigations, ISO 14971:2019 for risk management, and the technical reports ISO/TR 20416:2020 (PMS) and ISO/TR 24971:2020 (applying ISO 14971); and MEDDEV 2.7/1 Revision 4, cited only as pre-MDR methodological background. MDCG documents are guidance, not law; the MDR is the regulation; ISO 14155/14971 are standards; the ISO/TRs are technical reports; MEDDEV is pre-MDR. Source positions were verified in July 2026 and must be re-verified against the sources themselves before use.
Learn from Industry Experts
The course content is Whitehall Training editorial material, developed to reflect established practice in clinical evaluation and PMCF under the EU MDR - the way a Clinical Evaluation Plan, a literature search, an appraisal, an equivalence assessment, a Clinical Evaluation Report and a PMCF plan and evaluation report are actually built and defended, and the failure modes that appear when they are not. It is built around a single fictional case study, RhythmWatch Pro, a Class IIb wearable cardiac-monitoring device from Aurora Cardiac Systems, with a canonical set of components, evidence holdings and scenarios, so that every planning, search, appraisal, equivalence, sufficiency and PMCF decision in the course is one the learner can reason through. The MDR, MDCG guidance, MEDDEV and the ISO standards and technical reports are paraphrased and clause-referenced; they are never reproduced, and no MEDDEV or MDCG template text is copied beyond short labelled field names.
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