EU MDR Clinical Evaluation Requirement – Understanding the CER
A critical component of the Technical File Submission for the CE Marking /conformity assessment process is that clinical evaluation reports are essential to selling or distributing your devices in Europe.
However, many manufacturers struggle to comply with European CER requirements as there is a significant lack of clarity regarding critical elements and best practices for creating these reports.
Are you ready to impress your Notified Body and sail through your clinical evidence review? You won’t miss today’s deep dive if you are an aspiring CER writer or medical writer.
What is a Clinical Evaluation Report (CER)?
A CER documents the assessment and analysis of clinical data about a medical device to verify the device’s clinical safety and efficacy. Clinical data analysis based on either a clinical investigation of the device under evaluation or existing clinical studies for equivalent devices comprises a CER.
The goal for medical writers is to establish that any risks associated with the intended purpose of the device are acceptable when weighed against the benefits it offers users.
Requirements and Aims of the Clinical Evaluation
Prior to approval, a medical device manufacturer must prove that it meets the specifications and is safe. Clinical efficacy and safety should be continuously evaluated after the product is sold on the market.
Manufacturers can order clinical investigations in implantable devices and class III equipment to ensure the application of existing clinical evidence is justified unless it is sufficient.
Clinical evaluation explains some risk management measures, which are a vital component of risk management. The medical evaluation will have to change because two phases arise, both before and after the placement.
Clinical Evaluation of Medical Devices – MDR
Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous production, collection, analysis, and evaluation of clinical data.
It also confirms the safety and performance, including the clinical benefit of each for their intended use according to the manufacturer’s instructions.
The scope and emphasis in MDR clinical evaluations are more critical than in MDD. Besides MEDDEV 2.7/1 Rev.4, the new MDCG directives are needed. All medical device makers have to go through this process for each.
Which Medical Devices Need a CER under EU MDR?
Under the new EU MDR 2017/745, CERs will be required for all classes of products, and your notified body will strictly enforce this.
However, the depth and extent of evidence needed shall be proportional to the nature, classification, intended purpose, and risks of the device under evaluation and the medical device manufacturer’s claims about the device.
To illustrate, low-risk, well-established products like thermometers may not require clinical investigation. However, these devices must comply with safety and efficacy guidelines. And perform all the Post Market Surveillance (PMS) activities outlined in the regulation.
How to Prepare a Clinical Evaluation Report (CER)?
In line with MEDDEV. 2.7.1 Rev.4, the Clinical Evaluation Report (CER ) should cover all assessments of benefits and risks of possible relevance for using the device, following the intended purpose given by the medical device manufacturer and the specific claims made about the clinical efficacy and safety of the device. This document will be submitted in your technical documentation (tech file) to your notified body in Europe.
The clinical evaluation should be thorough and objective, emphasizing the significance of risks that remain after mitigation strategies have been employed by the manufacturer and should account for both favorable and unfavorable data.
Here are some elements that should be included in the CER scoping process. However, some apply only to “new” devices getting CE Marking for the first time.
- General information about the device, such as the device and manufacturer name, CE Marking status of the device, where the device is marketed outside Europe
- Intended use and Indications for use
- Technical device description & specifications, including images as they exist
- Overview of intended claims
- The current state of the device
- Clinical evaluation comprising a summary of clinical data, analysis, and review
- Risk management documentation- Assessment of performance, safety, and conformity to claims & standards
One must also consider the risk management files and demonstrate compliance with appropriate standards such as IEC 60601-1 (electrical safety) and EN 62366 (usability).
It is essential to ensure consistency with relevant clinical data. And describe the merit and limitations of any data cited or included in the evaluation.
Read More on Completing an EU MDR Clinical Evaluation Report
What is a Clinical Investigation Plan?
It could lead to medical devices. There was also a program of clinical investigations. The clinical investigation plan includes, among others, clinical testing.
What is the Clinical Investigation?
Clinical investigations are clinical trials of one or more patients for evaluation or safety purposes performed by the dyad, i.e., at least in the human subjects of Article 2(45) definition of Clinical Investigation. It means any systematic investigation of one or more people.
ISO 14971:2019 emphasizes three principles that should direct the supplier towards minimizing or reducing risk along the approval or follow-up approval pathway. First, every medical device is vulnerable to damage.
Manufacturers need to define the purpose of clinical trials and their interaction with their quality management system. These international standards, ISO 14155:2020:2020 and ISO-TR 24971:2020, allow manufacturers to ensure safety.
Are additional clinical investigations required?
Unfortunately, no hard rule determines whether the clinical data collected is enough to meet the EU MDR’s General Safety and Performance Requirements (GSPR). It must conduct an in-depth gap analysis to decide if additional clinical investigations will be required. Factors such as long-term device performance, safety under extensive use, and rare complications which may lead to safety risks or affect the performance should also be considered during the evaluation.
Is the Clinical Evaluation Report (CER) a One-time Activity?
Though the Clinical Evaluation Report (CER) needs to be completed before market launch to support the safety and performance of the device, it is a lifecycle activity that continues well into post-market. All post-market processes, including surveillance and vigilance activities, feed into the CER.
They are used to determine the overall acceptability of the device basis its risk/benefit analysis. Therefore, any notable changes that impact the initial data should be recorded, and the CER should be updated accordingly. Failure to do so could risk conformity with the MDD/MDR.
Summary: You will likely need to engage a cer writer continuously to update your report over the years.
How will Europe’s New Medical Device Regulation (EU MDR) Impact CERs?
This can broadly explain the significant impact in terms of more stringent requirements for CERs, such as the grounds of establishing an equivalence with another device, the quality of data and processes considered in the clinical evaluation, and increased post-market surveillance Stricter Criteria for establishing equivalence. In addition, a uniform review of sales literature from comparable products and services can contribute to an extensive and helpful product review.
A literature review of existing products having similar technical, biological & clinical specifications may help identify equivalents and provide an understanding of the current state of the art.
Medical Device Manufacturers must demonstrate that the device under evaluation is substantially equivalent in terms of safety and effectiveness to the aforementioned equivalent products (technically termed predicates).
Essentials of a Clinical Evaluation Report for Medical Devices
A redesigned directive for medical products introduced in May 2017 has stricter criteria for CER cases. Devices with more significant potential patients for harm require more in-depth CER. But the more information is in play, the more detailed our assessment should be.
This demonstrates that understanding the requirements for a CER will enable you to plan and spend enough information in an organized way to accomplish the process quickly. We will explain the essential parts of a clinical analysis report. It will also show you how to use the necessary resources to do a CER efficiently to complete the report.
Greater emphasis on clinical investigations – Your CER Writer and Effective Literature Search
The EU MDR has raised the bar on the need for clinical evidence and evaluation, which may necessitate a modification in CER processes, the collection of additional data from clinical investigations, and the expected level of scrutiny.
Manufacturers often submit literature reviews containing existing clinical studies for equivalent products. With the EU MDR, scientific literature as a sole means for clinical assessment will become strictly regulated. Though time-consuming and more expensive, pre-market clinical studies are essential for new technology and indications.
The specific ‘requirements’ for Lit Search and Review are still likely to be graded on the meddev 2.7 1 rev 4 requirements for clinical evaluation.
This is not mandated explicitly by MDR, but we know it is common among Notified Body Reviewers. Your CER writer and medical writing staff must be familiar with meddev 2.7.1 to conduct these reviews effectively.
Additional data from PMS post-market surveillance activities and post-market clinical studies, such as post-market clinical follow-up (PMCF), should include in the CER. They should organize and develop in a uniform and smoothly reproducible process.
What About Post Market Surveillance under EU MDR?
All clinical evaluation reports contain a section where you must commit to your Post Market Surveillance and Vigilance action plan. This will include the ‘how’ and the ‘how often’ of your Periodic Safety Update Report and Post Market Clinical Follow-up. Your regulatory team will need to work with your CER writer to define a plan that both conforms to regulation AND is manageable for your company to keep up with.
See our free PMS templates and guides for a complete overview of your EU MDR PMS plan.
Enhanced examination of CERs by Notified Bodies (NBs)
Manufacturers will require to re-evaluate the CERs across their portfolios. Thich is essential when supporting the initial CE Marking with limited clinical data.
High-risk device manufacturers such as class III or implantables should compile and submit a summary of safety and clinical performance on the European Data Bank on Medical Devices (EUDAMED) database.
However, clinical data is a must if clinical data is not available in the published literature, even for lower-risk cases. Or if the device has a novel feature. Suppose your literature searches are not comprehensive enough. You will undergo additional scrutiny and, in some cases, may require to conduct your studies. We recommend conducting the most comprehensive literature search and review possible. Join our mailing list for more on defining a good search strategy and protocol.
With the implementation of the EU MDR, the tune is set to change towards heavier post-market surveillance requirements. This means more emphasis on risk management, post-market clinical evaluation, and ensuring conformity to new specifications through the device lifecycle.
Manufacturers can reduce the time to market for new entrants. This may save their save valuable time & money by optimizing clinical evaluation processes appropriate for that device and lowering risks of recalls and lawsuits. However, your CER writers will have their hands full if they are not adequately prepared!