Clinical Evaluation Report (CER) under EU MDR 2017/745
The Clinical Evaluation Report is the single most scrutinized document in your MDR submission. Learn what Notified Bodies expect, how to structure your CER, and how to avoid the most common deficiencies that delay CE marking.
What Is a Clinical Evaluation Report?
A Clinical Evaluation Report (CER) is a mandatory document under EU MDR 2017/745, Article 61 and Annex XIV. It presents the results of the clinical evaluation process, demonstrating that the medical device achieves its intended purpose, delivers the claimed clinical benefits, and has an acceptable benefit-risk profile based on the current state of the art.
The CER is not a standalone document. It draws from and connects to multiple elements of your technical documentation: the Clinical Evaluation Plan (CEP), the State of the Art (SOTA) analysis, the risk management file (ISO 14971), the Post-Market Clinical Follow-up (PMCF) plan and report, and your post-market surveillance data.
When Is a CER Required?
A CER is required for every medical device placed on the EU market under MDR, regardless of device class. There is no exemption. Even Class I devices under Article 61(10) must perform a clinical evaluation, although the depth of clinical data may differ.
- Class III and implantable devices Require the most extensive clinical evidence, typically including clinical investigation data unless equivalence to an existing device can be demonstrated under the strict criteria of Article 61(4)-(5).
- Class IIb and IIa devices Clinical evaluation based on literature, equivalent device data, and/or clinical investigation data. The depth depends on the novelty and risk profile of the device.
- Class I devices (Article 61(10)) Manufacturers must still identify relevant benefit-risk parameters from the state of the art, even if clinical data requirements are reduced.
CER Structure: What Every Report Must Include
Based on MDR Annex XIV Part A and MDCG 2020-13 guidance, a compliant CER should include the following sections:
| Section | Purpose |
|---|---|
| Device Description | Technical specifications, intended purpose, target population, indications, contraindications |
| Clinical Background | Disease or condition context, standard of care, treatment alternatives |
| State of the Art (SOTA) | Current knowledge on the clinical area, accepted benefit-risk parameters, benchmark data |
| Equivalence Assessment | Technical, biological, and clinical comparison with equivalent devices (if applicable) |
| Literature Review | Systematic search protocol, database selection, inclusion/exclusion criteria, data appraisal |
| Clinical Data Analysis | Summary and critical evaluation of all available clinical evidence |
| Benefit-Risk Determination | Quantified benefit-risk analysis comparing device performance against the state of the art |
| Conclusions | Conformity statement, residual risks, sufficiency of clinical evidence |
| PMCF Plan Reference | Link to ongoing post-market clinical follow-up activities |
Most Common CER Deficiencies
Based on Notified Body feedback and MDCG 2020-13 review criteria, these are the most frequent deficiencies that delay or block CE marking:
Weak SOTA Analysis
Treating SOTA as a simple literature dump instead of a structured analysis that defines benefit-risk parameters and acceptance criteria.
Unsupported Equivalence Claims
Claiming equivalence without demonstrating technical, biological, and clinical similarity. or lacking a contract with the equivalent device manufacturer.
Incomplete Literature Search
Using only one database, not documenting the search protocol, or failing to capture key publications that Notified Body reviewers find independently.
Missing Benefit-Risk Quantification
Stating benefits qualitatively without quantifying them against state-of-the-art benchmarks or comparing against alternative treatments.
Disconnect from Risk Management
Failing to link adverse events identified in literature to the risk management file, or not updating the CER when new post-market data arrives.
Outdated Clinical Evidence
CER not updated with recent literature, PMCF results, or vigilance data. MDR requires ongoing evaluation throughout the device lifecycle.
How We Help with Your CER
Dr. Hatem Rabeh and the Clinical Evaluation Navigator team provide end-to-end CER support for medical device manufacturers of all classes:
- ✓ CER Writing & Review Complete CER preparation aligned with MDCG 2020-13 expectations, or independent review of your existing CER before Notified Body submission
- ✓ Literature Search & Appraisal Systematic search across PubMed, Embase, and Cochrane using PICO framework with reproducible, documented methodology
- ✓ SOTA & Benefit-Risk Analysis Structured state-of-the-art analysis with quantified acceptance criteria and benchmarks
- ✓ Equivalence Assessment Technical, biological, and clinical equivalence documentation meeting Article 61(4)-(5) requirements
- ✓ Gap Analysis & CER Updates Identifying evidence gaps and updating your CER with new clinical data, PMCF findings, and vigilance reports
- ✓ Notified Body Query Response Drafting responses to NB deficiency letters and preparing for conformity assessment
Frequently Asked Questions
What is the difference between a CER and a CEP?
The Clinical Evaluation Plan (CEP) defines the scope, methodology, and acceptance criteria for your clinical evaluation. The Clinical Evaluation Report (CER) presents the results of that evaluation. The CEP is your plan; the CER is your findings. Both are required under MDR Annex XIV Part A.
How often must the CER be updated?
MDR requires that the CER be updated at least annually for higher-risk devices (Class III and implantables) and at appropriate intervals for other classes. The update must incorporate new clinical data from PMCF, post-market surveillance, vigilance reports, and new scientific publications.
Can I use a CER written under MDD for MDR?
A CER written under the Medical Device Directive (MDD/93/42/EEC) will generally not meet MDR requirements without significant revision. MDR introduces stricter requirements for state-of-the-art analysis, equivalence demonstration, benefit-risk quantification, and PMCF integration.
What does a Notified Body reviewer check in a CER?
Notified Body reviewers follow the MDCG 2020-13 assessment checklist. They verify: completeness of the literature search, appropriateness of the SOTA analysis, validity of equivalence claims, sufficiency of clinical evidence, and whether the benefit-risk conclusion is supported by the data presented.
Is a clinical investigation always required for Class III devices?
Not always. Article 61(4) allows Class III and implantable devices to rely on clinical data from an equivalent device, provided the equivalence can be demonstrated across technical, biological, and clinical characteristics. and the manufacturer of the equivalent device has granted a contract for access to technical documentation. Without this, clinical investigation is typically required.
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