Best way to write a Clinical Evaluation Report (CER) in 2026 following latest MDCG guidelines

While writing the Clinical Evaluation Report (CER) in compliance with the EU MDR, it is not sufficient to simply reference Regulation (EU) 2017/745, but it should also demonstrate the with the alignment with applicable MDCG guidance for ongoing device safety and performance throughout its lifecycle. It must be ensured that the CER not only meets the legal requirements but also aligns with MDCG (Medical Device Coordination Group) guidance, which defines how MDR requirements are interpreted during conformity assessment. Although MDCG documents are not legally binding, they have become the primary benchmark used by Notified Bodies to assess the adequacy, structure, and scientific rigor of clinical evaluations.

The legal foundation of your CER remains Article 61 and Annex XIV, Part A of the MDR, which requires the planning, conduct, and documentation of a systematic clinical evaluation to demonstrate safety, performance, and benefit–risk acceptability. MDCG guidance clarifies what constitutes sufficient clinical evidence and how that evidence should be analysed and presented. Therefore, a CER must be MDR-compliant in law but MDCG-aligned in practice.

1.  Structuring the CER based on MDCG 2020-13

While no single MDCG document prescribes a mandatory CER template, MDCG 2020-13 provides a Clinical Evaluation Assessment Report (CEAR) template that reflects how Notified Bodies review CERs. When you structure your CER in alignment with this guidance, you improve clarity, facilitate review, and reduce the likelihood of regulatory findings.

Why it matters:

MDCG 2020‑13 provides key guidance for the preparation and structuring of a CER.

It explains exactly how Notified Bodies assess and review CERs.

It defines expectations for Clinical evidence sufficiency, Benefit–risk conclusions, and PMCF integration.

2.   Clinical Evaluation Plan (CEP) Alignment per MDCG Expectations

MDCG guidance emphasizes that your clinical evaluation must be planned and documented systematically. Notified Bodies will verify traceability between your Clinical Evaluation Plan (CEP) and the CER, as outlined in MDCG 2020-13. You should clearly reference the approved CEP version in your CER and demonstrate that your literature searches, appraisal criteria, and data analysis methods were conducted as planned. Any deviations must be scientifically justified and documented.

Why it matters for your CEP:

The requirement for a CEP originates from MDR Article 61 and Annex XIV, and MDCG guidance defines how its adequacy is interpreted by Notified Bodies.

MDCG 2020-13 makes CEP/CER traceability a formal assessment point and reviewers will verify that your clinical evaluation was planned prospectively and executed as defined.

Your CEP must be approved, version-controlled, and finalized before CER execution, preventing retrospective justification of clinical evidence.

Notified Bodies use MDCG templates and checklists during audits, so CEP quality directly impacts your CER outcomes.

Poorly defined or non-traceable CEPs are a common root cause of Major Non-Conformities during MDR conformity assessments.

3.  MDCG guidance documents based on conformity assessments

MDCG 2020-5 — Clinical Evaluation: Equivalence

This guidance explains how manufacturers can demonstrate clinical equivalence between a new device and an existing one to support clinical evaluation under the MDR. It clarifies the MDR criteria for equivalence, requiring alignment in “technical, biological, and clinical characteristics”. Compared with MEDDEV 2.7/1 rev. 4, the MDR approach is significantly more restrictive. For Class III and implantable devices, equivalence can only be claimed against another MDR-certified device, with full access to its clinical data. The document supports manufacturers and notified bodies in determining when equivalence-based clinical data is acceptable for conformity assessment.

MDCG 2020-6 — Sufficient Clinical Evidence for Legacy Devices

This guidance addresses how to establish sufficient clinical evidence for legacy devices transitioning from the MDD to the MDR. It explains how existing clinical data such as literature, prior investigations, and post-market clinical data can be assessed against MDR standards for quality, relevance, and scientific validity. The document helps manufacturers determine whether current evidence is adequate or whether additional clinical investigations are required, supporting a structured and justified transition to MDR compliance.

4.  Critical Appraisal of Evidence per MDCG 2020-13

While preparing the Clinical Evaluation Report (CER), particular attention should be paid to the critical appraisal of clinical evidence. MDCG 2020‑13 requires that the CER adequately evaluates the scientific validity, relevance, limitations, and potential bias of the data. The report should clearly explain the weighting of evidence and justify how individual sources support device safety and performance claims. Simply summarizing data is considered insufficient under MDCG review practice.

5.  Benefit–Risk Analysis and GSPR Compliance (MDCG Focus)

The CER must demonstrate a clear benefit–risk assessment. According to MDCG 2020‑13, the report should identify clinical benefits, quantify risks where possible, and show that benefits outweigh residual risks. Conclusions must align with the risk management file and demonstrate conformity with the General Safety and Performance Requirements (GSPRs) in Annex I of the MDR.

6.  PMCF Integration According to MDCG 2020-7 and MDCG 2020-8

Clinical evaluation is a continuous lifecycle process and should be aligned with post-market surveillance (PMS) activities. MDCG 2020‑7 (PMCF Plan Template) and MDCG 2020‑8 (PMCF Evaluation Report Template) provide guidance on how PMCF activities should be planned, conducted, and documented. The CER must incorporate available PMCF data and explain how post-market findings confirm or update earlier conclusions.

7.  Consistency with PMS per MDCG 2025‑10

CER conclusions must be consistent with PMS outputs, including PMS Reports and PSURs, by clearly demonstrating how post-market data has been systematically collected, analysed, and applied within the overall quality management system (QMS). MDCG 2025‑10 emphasizes that an effective PMS system should be proactive, continuous, and integrated with other key processes, such as risk management and clinical evaluation. Notified Bodies increasingly expect traceability from PMS data through to updates in clinical evaluation, including PMCF insights and PSUR conclusions. Any inconsistencies in safety trends, clinical claims, or conclusions may result in major non-conformities.

Why it matters:

Defines how PMS data (including PMCF and PSUR outcomes) must comply with the clinical evaluation process and lifecycle evidence updates.

Ensures alignment between post-market surveillance outputs and the benefit–risk conclusions presented in the CER, demonstrating ongoing device performance and safety.

8.  Additional MDCG Guidance Relevant to Specific Scenarios

Certain device categories require additional MDCG considerations.

MDCG 2019-9 is particularly important for the preparation and content of the Summary of Safety and Clinical Performance (SSCP) required for class II, ensuring that information is accurate, up-to-date, and consistent with the CER

MDCG 2024-15 is relevant when clinical investigation data are used, particularly regarding transparency and reporting

MDCG 2024-10 applies to orphan devices where limited patient populations justify alternative clinical evaluation approaches.

MDCG 2022-21 provides guidance on clinical evaluation for software and digital health devices, including the use of real-world evidence and performance data, which is increasingly relevant for devices incorporating software components or AI algorithms. Together, these MDCG documents help manufacturers tailor their clinical evaluation strategy to specific device categories and clinical scenarios, ensuring that CERs are robust, compliant, and aligned with Notified Body expectations.

9.  Identification of Clinical Data Using MDCG-Accepted Methodology

MDCG guidance requires transparency in the identification of clinical evidence. While MDR does not prescribe detailed literature search methods, MEDDEV 2.7/1 Rev. 4 remains an accepted methodological reference under MDCG practice when used alongside MDR. The CER should therefore follow MEDDEV principles for literature identification while ensuring overall alignment with MDCG 2020-13 expectations for traceability and justification of included data.

Key MDCG References for a Robust Clinical Evaluation Report (CER) in 2026

In conclusion, the CER should reference the following MDCG guidance along with EU MDR 2017/745 regulation, MEDDEV 2.7/1 revision 4, and IMDRF MDCE WG/N56FINAL:2019 (formerly GHTF/SG5/N2R8:2007) - Clinical Evaluation:

Essential for every CER depending on route of conformity:

MDCG 2020-13: Clinical evaluation assessment report template, July 2020.

MDCG 2020-6: Guidance on sufficient clinical evidence for legacy device, April 2020.

MDCG 2020-5: Guidance on clinical evaluation – Equivalence, April 2020.

MDCG 2020-7, Post market clinical follow-up (PMCF) Plan Template; A guide for manufacturers and notified bodies, April 2020.

MDCG 2020-8, Post market clinical follow-up (PMCF) Evaluation Report Template; A guide for manufacturers and notified bodies, April 2020.

MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices, December 2025.

Additionally, when applicable:

MDCG 2019-9: Summary of safety and clinical performance; A guide for manufacturers and notified bodies, August 2019.

MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745, December 2022.

MDCG 2024-10: Clinical evaluation of orphan medical devices, June 2024.

MDCG 2024-15: Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED, November 2024.

Incorporating these MDCG guidance document references ensures that your CER is methodologically transparent, evidence-based, and aligned with Notified Body expectations, minimizing review cycles and regulatory risk.