Clinical Evaluation Report for Medical Devices

Clinical Evaluation Report is specific to medical devices and is not for drugs. For drugs, a similar but distinct process is usually referred to as a clinical study report as part of the New Drug Application or Marketing Authorization Application submissions.

For drugs, the equivalent documentation includes Clinical Study Reports, which summarize the results of clinical trials, and Clinical Overviews / Summaries, which provide an overall assessment of the drug’s safety and efficacy based on clinical data. These are part of the regulatory submission process for drug approval.

In Medical Devices, the clinical evaluation report assesses the clinical data related to a medical device to ensure its safety and performance. It is a regulatory requirement under the EU Medical Device Regulation. So, while both CERs and CSRs involve the evaluation of clinical data.

New EU MDR Article 61, section 12 and Annex XIV – Part A, section 4 state the requirement for a CER for medical devices. This report, which documents all clinical evidence gathered during the clinical evaluation, must be included as part of the technical documentation to support the notified body assessment of the device’s conformity.

MEDDEV 2.7/1 Rev.4 is a guide for manufacturers and Notified Bodies for Clinical Evaluation for medical devices. This guidance document, details in stage 4 the requirement of a CER. As per this guidance, the report should contain enough information to be read and understood by an independent party such as a regulatory authority or notified bodies.

Thus, it should provide enough detail for understanding the search criteria adopted by the evaluators, available data, all assumptions made, and all conclusions reached. To obtain CE Certification for medical devices, the applicant must have thorough clinical documentation, and an evaluation report included as part of the Technical Documentation. No matter what the risk class of the device.

A clinical evaluation report is a living document that needs to be updated throughout the medical device’s lifespan. When new information about your device becomes available through post-market surveillance or a fresh literature search, the CER must be revised to reflect this.

Even if no new information is received, your report must be updated as per the internal clinical evaluation procedure. The CER for Class III or Class IIb implanted devices must be updated annually. The CER must be updated every two to five years for devices that pose no major risk.

Preparing a clinical evaluation report involves several steps, each of which is crucial for demonstrating the safety and performance of a device as required by European medical device regulation in article 61. The fundamental rule behind a good CER is as follows;

• Should be in detail and address MDR Article 61 sections
• Present the clinical data, including the synthesis of data from clinical investigations, literature, and PMS
• Manufacturers should follow MEDDEV 2.7.1 Rev. 4 guidelines during the data collection, evaluation and reporting.
• The CER must be objective, regardless of whether the data is positive or negative
• MDR CER should be thorough enough to build confidence among NB reviewers and subject experts
• The report for established devices can rely on existing market data, whereas novel devices require data from similar and equivalent devices.
• Summarize the findings of the clinical evaluation, concluding whether the device meets the relevant General Safety and Performance Requirements (GSPR)

The below steps ensures that the CER provides a robust documentation to prove clinical safety and performance, meeting Notified Body requirements for early CER approval.

Step 1: Identify the scope of the Clinical Evaluation Report

The scope of the MDR clinical evaluation report should include the identification of devices covered in this document. The products, models, sizes, software versions, accessories, whether it is on the market, since when, in what regions, history of the device, in case of an update in the plan, including date of past modifications with reasons and description, sales volumes, changes since the last report, and identification of the sections of the CER that are concerned with the new information and have been modified should be mentioned.

Step 2: Clinical Evaluation Report Planning

To plan a sound method for identifying, collecting, and analyzing the clinical data with the proper schedule and clinical evaluation team. Also, to develop the scope of the clinical evaluation to be conducted on the medical device.

Step 3: Data generated and held by the manufacturer

All premarket clinical investigations such as bench test reports include verification and validation data and clinical data generated from risk management activities and the PMS programs.

Step 4: Background, current knowledge, state of the art

A review of the current knowledge/state of the art is needed for the proper conduct of the appraisal and analysis of the device’s clinical data under evaluation and the equivalent device.

Summary and justification of the literature search strategy applied for retrieving information on current knowledge, including sources, keywords, selection criteria used, quality control measures, results, number, and type of literature, were pertinent. Appraisal criteria were also used to summarize.

Step 5: Clinical data from the literature

The primary plan is to identify three key sources of data that can be in a clinical evaluation report. They are.

• Trustworthy data /study comments published in medical journals.
• Unpublished, internal data.
• Complaint/post-market surveillance data.
• registry data (for class 111 devices)

Develop a well-defined plan of action (SOP) for searching the literature to make sure you attempt to find all possible data relevant to the device in question. The plan should consist of inclusion and exclusion criteria framed based on your device’s complexities and avoid analyzing the same data from multiple sources and reducing time searching.

Step 6: Summary and appraisal of data

Assess the overall quality of data that meets inclusion and exclusion criteria. The analysis of data allows for determining how much merit the data brings towards the conclusion. MEDDEV 2.7.1 Rev 4 Appendix C and D of the guidelines can be referred to understand more about suitability criteria and grading system.

Step 7: Complete Analysis

Analyzing the data in terms of their safety and performance is a big challenge because the quality of clinical data varies widely from study to study based on Safety, risk-benefit profile, Performance & Acceptability of side effects.

• The clinical evaluation report should consider potential risks posed by the device that has been identified in the risk management report. All possible risks and risk control measures from the risk management report would need to be addressed in the report conclusion.
• Information about the study population and diagnoses, intended purpose, and adverse events should be analyzed in detail.

Presentation of Clinical study data with positive and negative approaches is highly advisable to present in CER. They are (a) Text-based summaries of individual studies or of individual endpoints and (b) Visual summaries of pooled data. It is important to have a procedure that clearly defines your methodology followed in analyzing the data.

Step 8: MDR CER Annual Update

Many manufacturers assume that the CE report is done only once, but the reality is a big NO. It’s important to realize that the entire process including the report writing should be repeated regularly. Any significant changes which affect the initial collection of data should be recorded, and the CER be updated accordingly.

The manufacturer should actively collect information from post-market experiences with their devices based on a PMS plan.  Relevant data collected through the PMS should be used to update any relevant part of the CER. Updated report to be submitted to Notified Body or competent authorities when requested or during an annual surveillance audit