Buy the GCP R3 course & get a FREE eBook— your complete ICH-GCP R3 reference guide. Book Now →

  • AI ClinicalAI ClinicalNewRight Arrow
  • Clinical PracticeClinical PracticeRight Arrow
  • PharmacovigilancePharmacovigilanceRight Arrow
  • ManufacturingManufacturingRight Arrow
  • Laboratory PracticeLaboratory PracticeRight Arrow
  • DistributionDistributionRight Arrow
  • Medical DevicesMedical DevicesRight Arrow
  • Regulatory AffairsRegulatory AffairsRight Arrow
  • Research ComplianceResearch ComplianceRight Arrow
  • Health & SafetyHealth & SafetyRight Arrow
  • Quality AssuranceQuality AssuranceRight Arrow
  • All Bundles
  • Clinical Trials Development
  • GCP & GxP Standards
  • GMP & Quality Assurance
  • Pharmacovigilance
  • Role Based
  • Distribution
  • Medical Devices
  • Medical Writing
  • AI Clinical
  • Quality Assurance
  • Customize your bundleBuild your own path
View all 28 learning paths
  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations Learning Path - courses at £199

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
📢 Every purchase also includes our FREE companion Clinical Evaluation Reports and PMCF under EU MDR eBook, designed to help you apply principles in real-world clinical trial settings.

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

  1. Why clinical evaluation and PMCF are a continuous lifecycle, not one-off documents
  2. The six clinical-evidence discipline rules the course will not bend
  3. Clinical evaluation, clinical investigation, PMCF and PMS - told apart
  4. 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
  5. The RhythmWatch Pro case study (fictional) and the scenarios CS-01 to CS-08
  6. The 20 templates and the Clinical Evaluation Report you build towards
  7. Assessment, pass mark, certificate and its limits

  1. Clinical evaluation as a continuous lifecycle process under the MDR
  2. Article 61 and Annex XIV Part A: what the regulation requires
  3. Clinical data versus clinical evidence - the distinction that runs through the course
  4. Clinical evaluation, clinical investigation, PMCF and PMS - four different things
  5. GSPRs (Annex I), the risk framework and where clinical evidence sits
  6. The MDCG guidance landscape and the pre-MDR status of MEDDEV 2.7/1 Rev 4
  7. RhythmWatch Pro: the device, its components and its clinical-evidence challenge

  1. Developing a Clinical Evaluation Plan under Annex XIV Part A
  2. Defining intended purpose, population, indications and contraindications
  3. Writing clinical claims - safety, performance and benefit
  4. The Clinical Claims Register: tracing every claim to evidence
  5. Mapping clinical evidence to the general safety and performance requirements
  6. The GSPR Clinical Evidence Matrix as the spine of the CER
  7. RhythmWatch Pro CS-01: the CEP and clinical claims

  1. Defining state of the art and benefit-risk benchmarks before analysis
  2. The State-of-the-Art Framework: current care, alternatives and comparable devices
  3. Developing a reproducible literature-search protocol with PICO
  4. Search strategy, databases and documented search strings
  5. Screening, classifying and documenting literature (PRISMA-style)
  6. Why literature volume is not clinical evidence
  7. RhythmWatch Pro CS-02: the state-of-the-art analysis and the search

  1. Appraising relevance, methodological quality and scientific validity
  2. Turning clinical data into clinical evidence through appraisal
  3. The Clinical Data Extraction Table and the Appraisal Tool
  4. Identifying and evaluating manufacturer-held clinical data
  5. Analysing appraised data against the device, population and claims
  6. Common failures: volume mistaken for evidence, data mistaken for evidence
  7. RhythmWatch Pro CS-03: appraising the manufacturer-held data

  1. Equivalence across technical, biological and clinical characteristics
  2. Why a shared product code or intended purpose does not confer equivalence
  3. The equivalence restrictions and the data-access requirements (MDCG 2020-5)
  4. Determining whether clinical evidence is sufficient (MDCG 2020-6)
  5. The Sufficient Clinical Evidence Gap Assessment
  6. Identifying gaps and when a clinical investigation may be required
  7. RhythmWatch Pro CS-04 and CS-05: equivalence and the gap assessment

  1. Writing a structured CER to the assessed structure (MDCG 2020-13)
  2. Integrating risk, PMS, vigilance, complaints and PMCF evidence
  3. Stating benefit-risk and GSPR conformity conclusions
  4. Recording residual gaps and the PMCF that will address them
  5. What a notified body assesses - the CEAR perspective
  6. Common CER failures and how to avoid them
  7. RhythmWatch Pro CS-06: assembling the CER

  1. Developing a proportionate PMCF strategy (Annex XIV Part B)
  2. The PMCF Decision Tree: whether, and what, PMCF is required
  3. Selecting general and specific PMCF methods
  4. Writing the PMCF Plan to the MDCG 2020-7 structure
  5. The PMCF Data Collection Plan: objectives into executable data
  6. Why PMCF is not optional because a device is long-established
  7. RhythmWatch Pro CS-07: PMCF strategy, plan and methods

  1. Writing the PMCF Evaluation Report to the MDCG 2020-8 structure
  2. Feeding PMCF results back into the CER and benefit-risk
  3. Connecting PMCF to the CER, risk, PMS/PSUR and the SSCP
  4. The PMS-CER-Risk-PSUR cross-reference and lifecycle integration
  5. Establishing update triggers and frequencies by risk class
  6. Responding to notified-body clinical and PMCF deficiencies
  7. RhythmWatch Pro CS-08: PMCF reporting and deficiency response

  1. The six discipline rules, revisited
  2. The clinical-evaluation and PMCF lifecycle in one page
  3. The 20 templates and how to deploy them
  4. Common CER and PMCF failures, and how to avoid them
  5. Building your own clinical-evaluation and PMCF programme
  6. Final assessment and 80% pass mark
  7. Certificate of completion and its scope

  1. 📘 Bonus: Clinical Evaluation Reports and PMCF under EU MDR eBook (Free with purchase)

Our Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

Recommended Courses

Essentials of EU MDRBest Seller

Essentials of EU MDR

Professional
£493 hrs3 points
Sterilisation and Sterile Barrier Packaging Validation

Sterilisation and Sterile Barrier Packaging Validation

Intermediate
£393 hrs3 points
QMS for Medical Devices

QMS for Medical Devices

Professional
£493 hrs3 points
Software as a Medical Device

Software as a Medical Device

Intermediate
£393 hrs3 points
In Vitro Diagnostic MDR (EU) 2017/746

In Vitro Diagnostic MDR (EU) 2017/746

Professional
£392 hrs3 points