Kristina Zvonar Brkic No matter what medical device you make, if you wish to sell within the European Economic Area, you will need to meet the requirements of the Medical Device Regulation (MDR), and in particular the requirements for clinical evaluations of your medical device.
Elements of the MDR clinical evaluation report
- Summary
- Scope of clinical evaluation
- Clinical background, state of the art, current knowledge
- Device under evaluation
- Conclusions
- Date of next clinical evaluation
Many companies have difficulty understanding the section of the MDR regulations that defines the requirements for the clinical evaluation report for medical devices, so in this article you will find answers to many common questions on this report, which is necessary for providing medical devices in the EU market. If you are a provider of medical devices, and want to enter the EU market, it is vital that you understand this stage of the process.
What is a clinical evaluation of medical devices?
Medical devices need to be evaluated before they can be accepted, meaning that you will need to do some testing of the device to ensure both safety and efficacy. This testing can happen in a clinical setting, including actual patient trials.
Clinical evaluation is a systematic and planned continuous generation, collection, analysis and evaluation of clinical data. The purpose of clinical evaluation is to verify the safety, performance and clinical benefit of a medical device when it is used according to the manufacturer’s defined purpose. The guidance for medical device manufacturers that are required to perform clinical evaluations for their medical devices is included in Article 61 of the MDR.
The clinical evaluation takes place in three steps:
- Step 1 requires the medical device manufacturer to identify applicable existing clinical data for their medical device. This may come from clinical trials, preexisting literature, clinical experience or any combination of these.
- Step 2 entails review of the data collected for applicability, relevance, significance and quality.
- Step 3 requires that conclusions about the data be documented in the clinical evaluation report (CER) to demonstrate safety and performance of the medical device.
The clinical evaluation report is intended to use the data collected to demonstrate that the medical device that the company wants to distribute achieves its intended purpose without exposing patients, or other persons, to unnecessary hazards or risks. The CER is submitted as part of the European CE Technical File, a document required for any medical device distributed in Europe, and reviewed by the notified bodies.
What is a clinical evaluation plan?
The clinical evaluation plan, necessary for creating the CER, is detailed in paragraph 1 of Part A of Annex 14. This plan consists of the following stages:
- Stage 0 – Planning stage to create the clinical evaluation plan
- Stage 1 – Defining relevant clinical data
- Stage 2 – Appraising the clinical data
- Stage 3 – Either analysing the data, or generating new data through clinical investigations, depending on the outcome of the appraisal in stage 2
- Stage 4 – Producing the clinical evaluation report (per paragraph 4)
How do you write a clinical evaluation report?
So, what is included in the clinical evaluation report? The role of this report is to collect, assimilate, and present objectively the data for the medical device as collected in the clinical evaluation plan. The input for the report comes from many sources: manufacturers, quality specialists (for complaint data), librarians, safety specialists and scientists. The CER needs to include:
Summary. Overview of the clinical condition, and the state of the art for the medical device. What are the details of the subject device and its indication? What are the conclusions of the pre-clinical study evaluations, risk management, pre-market clinical investigations, published literature and post-market surveillance? What is the risk-benefit profile conclusion? This summary can often be up to two pages in length.
Scope of clinical evaluation. What are the objectives, chosen guidelines, standards and reference for CER evaluation? The scope should support the information that the device conforms to essential requirements for safety and performance as per the MDR. In addition, the scope indicates if the CER is to support an initial CE marking, a CE mark renewal, or is due to a request from a notified body.
Clinical background, state of the art, current knowledge. This section describes the current state of the art, or current knowledge, for the subject device that was used to appraise the current device. This comes from a literature search, separate from the search to appraise the device, to define the state of the art for other devices in a broad search with a recent timeframe (up to two years).
Device under evaluation. Description of the medical device for approval, with enough detail to assess compliance with essential requirements. Information should include device photographs, device diagrams, and usability testing data. For a device that is being marketed based on being equivalent to another device, this functional equivalence must be demonstrated based on technical, biological and clinical characteristics as well as pre-clinical studies, risk management, pre-market clinical investigations and post-market surveillance. The final, substantial section of the report is the clinical literature review, which can take as much time to write as the rest of the CER.
Conclusions. This section gives an outline of the device claims, either therapeutic or diagnostic, with a concise technical and physical description of the device based on the clinical evidence presented. In addition, a summary of the clinical evaluation, data types, and clinical data review is given.
Date of next clinical evaluation. It is required to define and justify the frequency of CER updates, and this is normally coordinated with the notified body audit and certification renewal process. These renewals can vary from one to five years, and depend on the risk source of the medical device.
What is post-market clinical follow-up?
The post-market clinical follow-up (PMCF) is defined in part B of Annex 14. The PMCF is a continuous process where the manufacturer will maintain a post-market surveillance (PMS) plan, and update the clinical evaluation reports as the PMS progresses. This can include extended follow-up with patients from the pre-market investigation, initiating new clinical investigations, or review of data collected from patients previously exposed to the device. These follow-up methodologies are identified in MEDDEV 2.12/2 rev 2, and this ongoing study intends to reduce any risks that still reside after product approval, as well as when any significant changes occur to the medical device or its intended use.
The CER is not optional
The clinical evaluation report is not an optional document; it is a crucial part of the CE technical file, which demonstrates the safety and performance of the device under approval. It is best to have the CER as a standalone document, to make it easier to update regularly as per the agreement with notified bodies. Remember, failure to complete or update the CER will risk the approval of your medical device, so take this critical function seriously.
To learn more about other documents required by the MDR, download this free white paper: EU MDR Checklist of Mandatory Documents.
