EU MDR Clinical Evaluation Reports for Medical Devices

EU MDR Clinical Evaluation Reports for Medical Devices

The clinical evaluation process and its conclusions need to be planned and documented in the Clinical Evaluation Report (CER).

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EU MDR Market information

What is clinical evaluation under the EU MDR?

Clinical evaluation is one of the most resource-intensive activities required under the European Medical Devices Regulation (EU MDR 2017/745). It begins as early as the device design development stage and continues through risk management for as long as your device is on the market. Clinical evaluation is a continuous process of collecting and analyzing clinical data related to a medical device to demonstrate it meets General Safety and Performance Requirements (GSPRs) in Annex I of the MDR and that the risk-benefit ratio is acceptable. The clinical evaluation process and its conclusions need to be planned and documented in the Clinical Evaluation Report (CER), a living document included with your Technical Documentation (TD) and updated throughout a device's life cycle.

All medical devices must comply with clinical evaluation requirements to demonstrate clinical evidence and to obtain CE Marking under the MDR, including Class I self-certifying devices. Annex XIV, part A, of the MDR addresses minimum clinical evaluation and CER requirements. MEDDEV 2.7/1 rev 4, which was implemented in 2016 and applied under the Medical Device Directive (MDD), serves as relevant guidance for planning and conducting clinical evaluation and structuring the CER.

Clinical evaluation process under the MDR

The clinical evaluation process has five stages:

Define scope and establish Clinical Evaluation Plan (CEP).
The CEP is part of your Technical Documentation and serves as a comprehensive strategy for your clinical evaluation. The CEP maps your clinical data sources and methods to device design characteristics (such as intended use, equivalence, state of the art, and risks) to verify conformity with GSPRs. It is strongly linked to risk management activities and requires description of data analysis or setting acceptance criteria for the planned clinical evaluation. The CEP should be started as early as possible in design development and then updated regularly, as needed. The CEP should not be written retrospectively. The content of the CEP should reference the manufacturers' Quality Management System procedures and Technical Documentation.

Identify available data.
Next is a comprehensive literature review to gather all relevant data about your device and equivalent devices. Literature reviews should be systematic with clearly defined goals and search protocols, which must be traceable. Data sources can include scientific literature, regulatory databases, and clinical investigations for your device and/or similar or equivalent devices. The identification of similar or equivalent devices can support the state of the art of your device, which is why it is recommended to do these searches as early as possible in the clinical evaluation process.

Appraise relevant clinical data.
The CER must follow a detailed search protocol for identifying, appraising, and analyzing clinical evidence. All data should be considered and weighed based on its relevance and quality, for example:

Is the data about your device, a similar or equivalent device, or a device using the same technology?

Is the target population the same or similar?

Is the data published in a peer-reviewed medical journal?

Is it statistically significant?

All favorable and unfavorable data should be included. This step should be completed by qualified clinical evaluators, who must be appointed and named in the CER.

Generate new data as needed.
If there are any gaps in your data, you may need to conduct clinical investigations in accordance with a Clinical Development Plan (CDP), which should be part of the CEP.

Analyze data and establish Clinical Evaluation Report (CER)
The CER reflects the scope of your clinical evaluation, types of data, data sources, literature review strategy, and appraisal, and finally addresses the clinical evidence. It summarizes your analysis of the relevant clinical and other performance data, outlining the rationale that it supports the device’s conformity with GSPR’s and their suitability for the claims defined in the intended purpose and labeling.

When to complete the Clinical Evaluation Report

The CER needs to be completed before the initial conformity assessment and included with your Technical Documentation for Notified Body review. It should include the projected date of your next CER, since clinical evaluation is a continuous process, and with justification for the timing of your clinical evaluation update. For Class III and Class IIb implantable devices, the CER must be updated at least annually. For other devices, it should be updated every 2-5 years. However, the CER should be updated more frequently if relevant post-market surveillance (PMS) data or other clinical evaluation data surfaces.

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more EU MDR services

MDR CE Marking Approval

MDR Classification

Post-market Clinical Follow-up (PMCF)

EU Authorized Representative

EUDAMED Registration

CE Mark Notified Body Search & Selection

Person Responsible for Regulatory Compliance (PRRC)

MDR & IVDR Post-Market Surveillance (PMS)

Documents and links

EU MDR, Annex XIV, part A

MEDDEV 2.7/1 rev. 4

How We Can Help

Plan your MDR clinical evaluation report with help from our experts

Clinical evaluation is a core element of your Technical Documentation. Conducting clinical evaluation activities, planning your CEP, writing and maintaining your CER are required for as long as your device is on the EU market. Pure Global’s team of medical device consultants have deep experience with clinical evaluation and literature review for a range of medical device types and technologies. We can help you plan and execute clinical evaluation activities that support your device’s ongoing conformity with MDR requirements.

Frequently
Asked Questions

Why do you need to plan for the clinical evaluation and document this in a CEP?

The MDR Article 61 and Annex XIV Part A require all medical device manufacturers to plan the clinical evaluation through a CEP. This record is an important document to identify the strategy and the systematic approach taken by the company to meet the clinical evaluation regulatory requirements under MDR. As a strategy, it should not be written retrospectively. Instead, it should be written as early as possible in the design development and linked to other company procedures and the quality management system, and then updated, as needed.

The CEP acts like a recipe. It should define the methods and guide involved personnel through the different stages of the clinical evaluation process to ensure efficient and objective data collection from start to finish. If you missed writing a CEP, reviewers will see that you have not followed a strategy or systematic approach. The date of your first version of the CEP should somehow match your design development dates and should cover a reasonable period until the CER has been created.

What is state of the art for medical devices?

“State of the art” is often used to reference advanced or innovative technology. However, in the context of medical devices, it refers to industry best practice. State of the art is the currently accepted technology for a type of device or clinical practice for treatment of a specific condition or disease. While the state of the art is always shifting, establishing the current state of the art for your device contextualizes the acceptability of your device technology. Fundamental elements for demonstration of state of the art is the compliance to current technical standards and most recent literature.

Who should conduct the clinical evaluation for a medical device?

MEDDEV 2.7/1 rev 4 specifies the qualifications of the individual or team conducting the clinical evaluation, which must be disclosed in the clinical evaluation report. This includes so-called clinical evaluators, who need to be qualified and appointed to evaluate the collected clinical data. At minimum, your clinical evaluators should be experienced with the clinical evaluation research methodology and regulatory requirements, as well as knowledgeable about the device technology, its application, and the conditions intended to be diagnosed or managed by the device. Clinical evaluators should have at least 10 years of combined relevant education and experience. Note that clinical evaluators are not necessarily the people who are doing the medical writing of the CER, they may be limited to appraising the collected clinical data.

How do we determine if clinical investigations are needed?

Class III and Class IIb implantable devices are required to perform clinical investigations. If your device is novel or expands on the intended purpose of an otherwise equivalent device, you may need to conduct clinical investigations. All clinical investigations must be conducted in accordance with EN ISO 14155 to reflect the basic Good Clinical Study Practice and ethical and regulatory requirements. If clinical investigations are not lawfully approved by the national competent authorities and have not been given a favorable opinion of the involved Ethics Committee, they typically are not accepted for CE Marking. Beyond these scenarios, clinical investigations are necessary any time there is insufficient clinical data to support your device’s conformity with GSPRs and justify its benefit/risk ratio, safety, performance, and the acceptability of potential side effects. This justification is the outcome of the CER, and it must be demonstrated to external reviewers through objective evidence that there are no remaining risks.

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