MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices
ANSWERED ON THIS PAGE:
- What is a clinical evaluation report?
- Who is required to produce a clinical evaluation report?
- How is clinical data defined in MEDDEV 2.7/1 revision 4?
If you plan to sell your medical devices in Europe, you must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745. Your CER documents the result of the clinical evaluation of your device. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device.
Clinical evaluation reports are an important step in the path to CE Marking. Many manufacturers struggle to comply with European CER requirements - but Emergo has the experience with CE regulations and clinical literature reviews to help you prepare a fully compliant CER.
Preparing a Clinical Evaluation Report (CER) for medical devices
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
When to update your device CER
The initial report is just the beginning of your CER’s lifecycle. Update your CER regularly based on ongoing clinical evaluations, or as part of your post-market surveillance and vigilance operations. Updates to your CER are required:
- Every year, or...
- When you receive new information from post-market surveillance that could change the current evaluation, or...
- Every 2-5 years if the device is not expected to carry significant risks and is well established.
We can assist with your EU Clinical Evaluation Reports and literature reviews
Emergo specializes in reviewing medical device clinical data, and we can ensure your CER meets all European requirements. Our expert team of regulatory consultants brings depth of clinical experience with a range of medical devices and IVDs. We can:
- Gather and analyze appropriate scientific literature applicable to your device.
- Compile and draft the CER in compliance with EU requirements.
- Develop procedures to compile CERs and perform clinical literature reviews for future updates to your CER.
- If necessary, we can develop a protocol to methodologically search and evaluate journal articles and provide a synopsis.
Contact us for more information about how we can help you comply with MEDDEV 2.7/1 rev 4 and perform literature reviews.
Common CER questions
How will the new European Medical Devices Regulation (MDR 2017/745) impact CER requirements?
MDR 2017/745 and a revised CER guidance (MEDDEV 2.7/1 rev 4) were released. Both documents reflect more stringent requirements for clinical data. There will be a three-year transition period to the MDR, which becomes applicable in mid-2020. To learn more about CER requirements or the MDR, download our free in-depth white papers about Clinical Evaluation Reports or the changes: Understanding Europe's New Medical Device Regulation.
Will devices already on the market be required to show equivalence?
This depends on whether you are relying on clinical data that was generated on equivalent devices. If so, requirements for equivalence in rev 4 must be met, even if the device is already CE marked (the CER is an ongoing process). You may also replace the original clinical data on equivalent devices with PMS data gathered on the device itself.
How should manufacturers of small, simple, and safe devices (e.g., a thermometer) comply with the guidance if their product does not require a clinical investigation and/or does not have appropriate or available literature?
If you device is already on the market, PMS data should be available to support it. It’s important to clearly identify aspects of safety and performance that can only be addressed by clinical data and focus the CER on that data. A good review of the state of the art will also set the relative risks and benefits in context, as well as identify any standardisation of the device design that may help identify equivalent devices. However, even for lower classification devices, it may be necessary to conduct a clinical study if clinical data is not available in the published literature, or if the device has a novel feature.