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Clinical Evaluation and CER under MDR (MEDDEV and MDCG 2020-13) Course & Certification
Intermediate
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Clinical Evaluation and CER under MDR (MEDDEV and MDCG 2020-13)
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About
Clinical Evaluation and CER under MDR provides a practical overview of clinical evaluation requirements under Regulation (EU) 2017/745, supported by MEDDEV 2.7/1 Rev. 4 and applicable MDCG guidance, including MDCG 2020-13. The course helps learners understand the clinical evaluation process, regulatory expectations, clinical evidence requirements, and the role of clinical evaluation in demonstrating conformity with applicable General Safety and Performance Requirements (GSPRs).
This course covers clinical evaluation planning, literature searches, clinical data identification and critical appraisal, clinical evidence analysis, benefit-risk assessment, and Clinical Evaluation Report (CER) preparation and review. It also explores equivalence assessment where applicable, risk management, clinical investigations, post-market surveillance (PMS), and post-market clinical follow-up (PMCF). Upon successful completion, learners will gain practical knowledge to support clinical evaluation activities, prepare and review CERs, identify clinical evidence gaps, justify evaluation conclusions, and maintain appropriate clinical evidence throughout the medical device lifecycle.
Who Should Enrol?
- Clinical Affairs Professionals
- Regulatory Affairs Professionals
- Quality Assurance and Quality Management Professionals
- Clinical Evaluators and Medical Writers
- Medical Device Manufacturers
- Clinical Research Professionals
- Professionals involved in CER preparation, review, and maintenance
- Anyone involved in medical device clinical evaluation and regulatory compliance
What you will learn
Understand the clinical evaluation framework under EU MDR 2017/745, including the requirements of MEDDEV 2.7/1 Rev. 4, MDCG 2020-13, and the role of clinical evaluation in demonstrating medical device safety and clinical performance.
Learn how to plan and conduct clinical evaluations, including defining the scope, developing literature search strategies, identifying relevant clinical data, critically appraising evidence, and assessing its quality, relevance, and sufficiency.
Develop practical knowledge of Clinical Evaluation Report (CER) preparation and review, including clinical data analysis, equivalence assessment where applicable, benefit-risk evaluation, clinical evidence gaps, and the justification of clinical evaluation conclusions.
Understand the relationship between clinical evaluation, risk management, clinical investigations, post-market surveillance (PMS), and post-market clinical follow-up (PMCF), and learn how to maintain clinical evidence to support ongoing regulatory compliance throughout the medical device lifecycle.
Course Syllabus
- The duty, and Article 61 as a map
- Process, document, evidence
- MDCG 2020-13 is the notified body's report about your CER
- MEDDEV 2.7/1 revision 4, dated precisely
- The MDR requires; MDCG guidance recommends; notified bodies expect
- Guidance ages, and the transition running underneath
- COM(2025) 1023 is a proposal, and a proposal is not a plan
- The plan is where you commit in advance
- Scope comes from the purpose and the claims
- The state of the art is a determination
- The consolidated middle, not the frontier
- The phrase inside GSPR 1, handled honestly
- Three searches, and a protocol a stranger can re-run
- The lifetime, and the person who signs
- Three routes, and the choice between them is yours to justify
- The literature route, and why it fails so reliably
- Equivalence, taken through all three characteristic sets
- Article 61(5): somebody else's device, and the contract
- Clinical investigation, in outline and no further
- Article 61(10), and the mechanism nobody reads
- Legacy devices, well-established technologies, and software
- Reading the assessment in order to write the submission
- The chain, and how to walk it in both directions
- Benefit-risk, in the report, against the actual risks
- Claims the evidence does not support
- Consistency with the instructions for use and labelling
- The public summary, and the panel that reads your argument
- Where reports fail, what is measured, and the deficiency round
- Annex XIV Part B, and the two documents it creates
- A plan cannot substitute for data you never had
- A plan that specifies no threshold can never fail
- Article 61(11), Article 86, and the closed circuit
- The United Kingdom did not implement the EU MDR
- Part 4A, the recognition routes, and what is not law
- Three jurisdictions, one file, and which one you build to
- One question per module, and its answer in a sentence
- Every instrument in its correct box, at the verification date
- A plan scoped to a catalogue, with no bar set anywhere in it
- Two centres described, one search run, no determination made
- A report with sections where it needed an argument
- A follow-up plan that no result could ever have failed
- Readiness Check One to Three
- Where the proposal is, and why you may not plan on it
- What this course deliberately did not do, and why not
- 📘 Bonus: Clinical Evaluation and CER under MDR eBook (Free with purchase)
Course Benefits
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Earn CPD points to support your professional development in Clinical Evaluation and Clinical Evaluation Report (CER) requirements under EU MDR, including MEDDEV 2.7/1 Rev. 4 and MDCG 2020-13, subject to applicable eligibility criteria.
Certification
Receive a personal certificate upon course completion to demonstrate your knowledge of Clinical Evaluation and Clinical Evaluation Report (CER) requirements under EU MDR, including MEDDEV 2.7/1 Rev. 4 and MDCG 2020-13.
Affordable
Get excellent value with cost-effective pricing, plus group discounts for larger purchases.
Flexibility
Learn at your own pace with convenient online access, allowing you to complete the course anytime, anywhere.
Keep Up to Date
Stay informed about Clinical Evaluation and CER requirements under EU MDR, including MEDDEV 2.7/1 Rev. 4, MDCG 2020-13, applicable regulatory obligations, relevant guidance, and updates through regularly reviewed course content.
Learn from Industry Experts
Learn from clinical evaluation, regulatory, and quality professionals through practical insights into Clinical Evaluation and CER requirements under EU MDR, clinical evidence assessment, regulatory guidance, and applicable requirements outlined in MEDDEV 2.7/1 Rev. 4 and MDCG 2020-13.
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