Clinical Evaluation Reports (CERs) are a tool used by manufacturers to show their device is safe and effective. Since the passing of the European Union’s Medical Device Regulation (EU MDR 2017/745), the CER is more important than ever. If you’re new to medical device regulation, or if your legacy device must transition from the old Medical Device Directive (MDD), this post explains what a CER is, why it matters, and how it’s written.
A CER proves your device meets the MDR’s General Safety and Performance Requirements (GSPRs) that are appropriate for your device.
Notified Bodies won’t schedule a conformity-assessment audit without a complete, up-to-date CER.
Post-Market Clinical Follow-Up (PMCF) plans—and your Periodic Safety Update Report (PSUR)—must reference CER conclusions and are necessary for conformity to the risk management process.
A well-written CER follows the structure outlined in MEDDEV 2.7/1 Rev. 4 and aligns with MDR Annex XIV Part A. The CER may also reference MDCG guidance documents: 2020-5 (Guidance on equivalence); 2020-6 (Sufficient clinical evidence for legacy devices); and 2020-13 (MDCG CER Template) or other MDCG documents. While every device is different, most CERs include the following sections:
Details the device, its classification, and its medical purpose. This section also includes indications, contraindications, and target populations.
Describes current medical practice and establishes the baseline for comparing the safety and performance of your device to other available therapies and/or devices.
Includes all available data related to the subject device. Types of clinical data can include:
A systematic review of the quality, relevance, and validity of the data. The writer must determine if there is sufficient evidence to support the device’s safety and performance under the MDR.
Summarizes whether the device meets the appropriate General Safety and Performance Requirements (GSPRs), and if the benefits of the device outweigh the risks for the intended patient population. The benefit-risk analysis must take into account device safety, performance, and known side effects.
Under EU MDR, Clinical Evaluation Reports are not static documents. The frequency of updates depends primarily on the risk class of the device.
The EU MDR classifies devices into four risk-based categories. Each class has different expectations for how frequently the CER must be reviewed and updated:
➤ CER must be updated at least annually.
These devices require the most scrutiny. Frequent updates are essential to incorporate new clinical data, especially post-market clinical follow-up (PMCF) results.
➤ Update required at least every two years, or sooner if new data emerges that could affect the benefit–risk determination.
➤ Update required at least every three years, depending on post-market findings, product changes, or regulatory expectations.
➤ May require periodic updates based on post-market surveillance, although the formal CER update cycle is less prescriptive.
In addition to the regulatory minimums, a CER should be updated when:
Proactive CER maintenance is critical: waiting for a Notified Body to flag deficiencies can lead to delays, increased scrutiny, or certification risk.
Defines objectives, scope, endpoints, approach to clinical data, and literature-search strategy before data collection starts. Annex XIV Part A of the MDR calls it mandator Clinical Evaluation Plan (CEP)
Defines the objectives, methodology, and timelines for collecting post-market clinical data. It outlines how the manufacturer will proactively gather evidence to address clinical uncertainties and confirm the ongoing safety and performance of the device. This plan is a critical part of the Clinical Evaluation process and must be aligned with the overall Post-Market Surveillance (PMS) system.
Summarizes the data collected through PMCF activities, such as surveys, observational studies, or registry data, and evaluates how this information impacts the benefit–risk profile of the device. It demonstrates whether clinical evidence gaps have been addressed and supports the continuous validation of device performance and safety throughout its lifecycle.
Describes systematic procedures for collecting, analyzing, and responding to post-market data. Forms the foundation for continuous safety and performance monitoring under Article 84.
Aggregates and evaluates post-market data over a defined period. Required for Class IIa, IIb, and III devices. Must include conclusions on benefit–risk and actions taken.
Establishes a systematic approach for monitoring the performance and safety of a medical device once it is on the market. While Class I devices typically present lower risk, manufacturers are still required under EU MDR to proactively gather, assess, and analyze post-market data to ensure continued compliance and patient safety.
Delivers a public-facing summary of the device’s clinical evidence, safety profile, and performance. Required for Class III and implantable devices under Article 32.
Global Regulatory Writing & Consulting has authored and audited hundreds of MDR-ready CERs across all device classes with zero major nonconformities to date. Our seasoned writers and consultants can provide any number of the following services. We are eager to work with you and your team to find what suite of services may be best for you.
Let us help you assess your full device portfolio and map out a strategic, efficient path to compliance. From tailored clinical evaluation processes to full documentation support, our experts are equipped to guide you every step of the way.
Reach out today to accelerate your journey to MDR readiness.
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