MDCG 2020-13 is the Clinical Evaluation Assessment Report (CEAR) template used by Notified Bodies to document their assessment of a manufacturer’s clinical evaluation and supporting evidence under the EU Medical Device Regulation.
It is not a template for writing a Clinical Evaluation Report (CER), and it does not replace Article 61 or Annex XIV of the MDR. For manufacturers, its value is that it shows the questions, evidence and traceability a Notified Body is expected to examine during conformity assessment.
Reviewing a CER against the CEAR structure before submission can help identify unsupported conclusions, inconsistencies and missing evidence before the Notified Body begins its assessment.
Official MDCG 2020-13 resources
- Download the official MDCG 2020-13 PDF
- Download the official MDCG 2020-13 Word template
- View all current MDCG guidance documents
What Is MDCG 2020-13?
MDCG 2020-13 provides a standardised structure for the Clinical Evaluation Assessment Report prepared by a Notified Body. The CEAR records how the Notified Body has assessed the clinical evidence submitted by the manufacturer and the conclusions drawn from that assessment.
The CER and CEAR therefore serve different purposes:
| Document | Prepared by | Purpose |
|---|---|---|
| Clinical Evaluation Report (CER) | Medical device manufacturer | Documents the manufacturer’s clinical evaluation, supporting evidence and conclusions on safety, performance and clinical benefit |
| Clinical Evaluation Assessment Report (CEAR) | Notified Body | Documents the Notified Body’s assessment of the CER and related clinical evidence |
Manufacturers are not required to copy the CEAR structure when writing their CER. However, using its assessment criteria as a review framework can make it easier to verify that the CER provides a clear and traceable response to the matters the Notified Body must assess.
For a broader explanation of the manufacturer’s clinical evaluation process, see our guide to preparing an MDR Clinical Evaluation Report.
When Is the CEAR Used?
The official template applies to clinical evaluation assessments performed through several MDR conformity assessment routes. These include assessments under Annex IX, Annex X and the relevant technical documentation sampling provisions for Class IIa and Class IIb devices.
The CEAR allows the Notified Body to document:
- the device, manufacturer and conformity assessment concerned;
- the qualifications and roles of the reviewers;
- the clinical evaluation plan and report assessed;
- the device description, intended purpose and risk classification;
- the state of the art and any claimed equivalence;
- the clinical literature review;
- clinical investigations and their supporting documentation;
- post-market surveillance and post-market clinical follow-up;
- the IFU, SSCP, labelling and other information supplied with the device;
- identified deficiencies, manufacturer responses and the final assessment conclusions.
Additional sections apply when the assessment involves the clinical evaluation consultation procedure, Article 61(10), or voluntary consultation on the clinical development strategy.
What Does the CEAR Tell Manufacturers About Notified Body Review?
The CEAR provides a structured view of the evidence trail a Notified Body is expected to assess. Manufacturers can use the following sections to test the readiness of their clinical documentation.
| CEAR section | What the Notified Body assesses | What the manufacturer should verify |
|---|---|---|
| Sections A and B | Administrative information, CER references and reviewer involvement | Correct device identification, document versions, author details and available evidence of author competence |
| Section C | Device description, classification, clinical evaluation plan, intended purpose, standards, equivalence and state of the art | Consistency across the CEP, CER, technical documentation, risk management file, IFU and claims |
| Section D | Clinical literature review | Search methods, selection criteria, appraisal, data relevance, bias and reproducibility |
| Section E | Clinical investigations | Study design, conduct, results, limitations and relevance to the intended purpose |
| Section F | PMS, PMCF and planned updates | How post-market evidence feeds into the CER, benefit-risk determination and future updates |
| Section G | IFU, SSCP, labelling and other supplied information | Alignment of indications, contraindications, warnings, residual risks, user groups and clinical claims |
| Section H and overall conclusions | Sufficiency of the complete clinical evidence package | Whether the conclusions are supported by the evidence and linked to the relevant GSPRs |
| Sections I to K | Device-specific or pathway-specific considerations | Whether Article 54, Article 61(10) or Article 61(2) applies |
The objective is not to reproduce the CEAR inside the CER. The objective is to ensure that a reviewer can trace each important conclusion back to appropriate clinical evidence and related technical documentation.
How to Perform a Pre-Submission Review Using MDCG 2020-13
1. Confirm the document set and versions
Identify the exact versions of the CEP, CER, risk management file, IFU, SSCP, PMS plan, PMCF plan and relevant reports included in the submission.
Check that the device name, model, Basic UDI-DI, intended purpose, indications, target population and risk classification are consistent across these documents.
2. Trace clinical claims to evidence
List the clinical safety, performance and benefit claims made in the CER. For each claim, identify the supporting literature, clinical investigation, post-market data or other clinical evidence.
A claim should not depend on a citation that discusses a different device, population, indication or clinical outcome without an adequate justification of relevance.
3. Review the clinical evaluation methodology
Confirm that the literature search, selection, appraisal and analysis methods are documented clearly enough to be reproduced and assessed.
Check that the CER explains:
- which databases and sources were searched;
- the complete search period;
- the search terms and protocols used;
- the inclusion and exclusion criteria;
- how data quality, relevance and potential bias were assessed;
- how favourable and unfavourable data were handled;
- how the state of the art was established and maintained.
4. Examine equivalence claims separately
If the CER relies on an equivalent device, verify the technical, biological and clinical comparisons required by Annex XIV.
The manufacturer must demonstrate sufficient access to the data needed to justify the equivalence claim. A contract providing full access to another manufacturer’s technical documentation is required in the specific circumstances described in Article 61(5), but it is not a universal requirement for every use of equivalent-device data.
Use MDCG 2020-5 and MDCG 2023-7 alongside the MDR when reviewing equivalence.
5. Reconcile pre-market and post-market evidence
Verify that PMS, PMCF, vigilance, complaints and relevant real-world data are reflected in the current clinical evaluation.
Any new safety signal, change in use, emerging risk, systematic misuse or evidence affecting the state of the art should be assessed for its impact on:
- the CER conclusions;
- the benefit-risk determination;
- the risk management file;
- the IFU and warnings;
- the PMCF plan;
- the timing of the next CER update.
6. Record and resolve gaps before submission
Create a gap log containing the affected CEAR criterion, the relevant CER section, the missing or inconsistent evidence, the responsible owner and the required corrective action.
Do not close a gap only because the relevant topic is mentioned in the CER. Confirm that the evidence and rationale are sufficient to support the conclusion.
MDCG 2020-13 Readiness Checklist for Manufacturers
Before submitting the CER, confirm that:
- The device description and intended purpose are consistent across the CER, IFU, technical documentation and risk management file.
- The CER and CEP versions are clearly identified.
- The CER authors and evaluators have documented qualifications relevant to the device and clinical evaluation.
- The clinical evaluation objectives correspond to the intended purpose and applicable GSPRs.
- The state-of-the-art review is current, appropriately scoped and supported by identifiable sources.
- Literature search and appraisal methods are documented and reproducible.
- Both favourable and unfavourable clinical data have been considered.
- Clinical investigation results and limitations are accurately represented.
- Any equivalence claim addresses the technical, biological and clinical characteristics required by Annex XIV.
- The available level of access to equivalent-device data is documented and justified.
- Clinical safety, performance and benefit claims are traceable to supporting evidence.
- Residual risks and benefit-risk conclusions are consistent with the risk management file.
- The IFU, SSCP, labelling, warnings and contraindications reflect the clinical evidence.
- PMS and PMCF findings have been incorporated into the clinical evaluation.
- The rationale for the PMCF plan, including any decision not to conduct a particular activity, is documented.
- CER update triggers and planned review dates are defined.
- Outstanding gaps, contradictions and unsupported conclusions have been resolved or formally addressed.
How MDCG 2020-13 Relates to Other Clinical Evaluation Documents
MDCG 2020-13 should be used alongside the MDR and the guidance applicable to the device and evidence strategy.
| Document | Role in the clinical evaluation |
|---|---|
| MDR Article 61 and Annex XIV | Establish the legal requirements for clinical evaluation and its documentation |
| MEDDEV 2.7/1 Rev. 4 | Provides detailed clinical evaluation methodology that must be applied in the context of the MDR and subsequent MDCG guidance |
| MDCG 2020-5 | Explains the demonstration of equivalence |
| MDCG 2020-6 | Addresses sufficient clinical evidence for legacy devices |
| MDCG 2023-7 | Clarifies Article 61(4) to 61(6) exemptions and sufficient access to equivalence data |
| MDCG 2020-7 | Provides the PMCF plan template |
| MDCG 2020-8 | Provides the PMCF evaluation report template |
For more guidance on related documents, visit our MDCG guidance hub for MDR and IVDR.
Frequently Asked Questions About MDCG 2020-13
No. MDCG documents are not legally binding interpretations of Union law. MDCG 2020-13 provides a harmonised template that Notified Bodies use to document their assessment of clinical evaluation evidence under the MDR.
No. MDCG 2020-13 is a Notified Body assessment template, not a mandatory CER template for manufacturers. A manufacturer may use its criteria to improve traceability and identify gaps, but the CER must satisfy Article 61, Annex XIV and the other applicable MDR requirements.
No. Following the structure does not demonstrate that the underlying evidence is sufficient. The Notified Body will assess the quality, relevance and completeness of the clinical evidence, the methodology used and whether the manufacturer’s conclusions are justified.
No. Annex XIV requires sufficient access to the data needed to justify equivalence. A contract providing full and ongoing access to another manufacturer’s technical documentation is an additional requirement in the specific Article 61(5) exemption scenario. MDCG 2023-7 explains the different levels of access that may be relevant in other circumstances.
Need a Pre-Submission Review of Your CER?
MDx CRO supports medical device manufacturers with clinical evaluation planning, CER preparation, clinical evidence gap assessments and responses to Notified Body questions.
If you need an independent review before submission, our regulatory team can assess your CER and supporting documentation against the relevant MDR and CEAR criteria.
