CER: Scientific Proof of Device Safety and Performance
Under the Medical Device Regulation (MDR), the most critical and scrutinized component of the Technical Documentation (Part 4) on the path to the CE mark is the Clinical Evaluation Report (CER). The CER is a systematic and scientific analysis of clinical data that demonstrates the device is safe and performs as intended under normal conditions of use. The MDR details the process and content of the CER in Annex XIV [1].
Purpose and Importance of the CER
The primary purpose of the CER is to prove that the device meets the General Safety and Performance Requirements (GSPR) outlined in MDR Annex I.
- Safety: To demonstrate that the benefits of the device outweigh its known or foreseeable risks.
- Performance: To prove that the device achieves the clinical benefit claimed by the manufacturer.
The CER is not a one-time document but a living document that must be kept up to date throughout the device’s entire lifecycle. Especially for high-risk devices (Class IIb and III), the CER is the section that Notified Bodies (NBs) examine with the utmost rigor.
The Clinical Evaluation Process: A 3-Stage Cycle
The clinical evaluation process, according to the MDR, is a cyclical process consisting of three main stages:
Stage 1: Planning (Clinical Evaluation Plan – CEP)
In this stage, the manufacturer outlines a roadmap for preparing the CER. The Clinical Evaluation Plan (CEP) details what clinical data will be collected, how it will be analysed, and which GSPRs will be addressed.
Stage 2: Data Collection and Analysis
This stage involves gathering and assessing the clinical data that forms the basis of the CER. Data sources are divided into three main categories:
- Literature Data: Scientific publications, articles, and clinical guidelines related to the device.
- Clinical Experience Data: Data collected after the device is placed on the market (e.g., Post-Market Surveillance – PMS data, complaint records).
- Clinical Investigation Data: Data obtained from clinical investigations conducted by the manufacturer on their own device.
Stage 3: Reporting (Clinical Evaluation Report – CER)
All collected and analyzed data are systematically reported in the CER, in accordance with MDR Annex XIV. The report provides the final scientific evidence proving the device’s conformity to the GSPRs.
Structural Components of the CER
An MDR-compliant CER typically includes the following key sections:
Section | Content | Focus |
Introduction and Scope | Device description, intended purpose, risk class, and summary of the CEP. | Device identity and regulatory context. |
Clinical Data Collection | Literature search protocol, databases used, justification for selected and excluded publications. | Transparency and systematic nature of the data collection process. |
Clinical Data Analysis | Scientific evaluation of the collected data, analysis of the benefit-risk ratio, and proof of equivalence claims. | Reliability of data and device performance. |
Conclusion and Benefit-Risk Assessment | Final conclusion on the device’s conformity to GSPRs, acceptability of residual risks, and frequency of CER updates. | The final declaration of MDR compliance. |
MPH CTC and the CER Process: Speed and Quality
CER preparation requires not only medical writing skills but also deep regulatory knowledge and expertise in clinical investigation methodology. At MPH CTC, we offer strategic support to overcome the biggest challenges in the CER process:
- Systematic Literature Review: We conduct comprehensive and reproducible systematic literature reviews in compliance with MDR requirements.
- Clinical Data Bridge: When existing data is insufficient, we plan and execute new clinical investigations to support the CER in the fastest and most ethical manner.
This approach minimizes time loss during Notified Body audits, thereby shortening the time it takes for your device to achieve the CE mark.
References
[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Annex XIV.
[2] MDCG 2020-1 Guidance on clinical evaluation (MDR). European Commission.
[3] Guide to Clinical Evaluation Reports (CER) for Medical Devices.namsa.com.