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If you plan on selling a medical device in the European Union, then you should plan on writing a clinical evaluation report (CER). Your CER will document the clinical evaluation that is required of every medical device sold in the EU. Its purpose is to prove your device performs as intended without compromising the safety of its end users.
Even if your device falls into the lowest risk class possible, you’ll still need a CER in your technical file when you submit it to your Notified Body. With so much riding on the CER, it’s essential that you create a well-structured and comprehensive report.
That’s why we’ve devoted the final article in our four-part series on clinical evaluation to the writing of the CER. Keep reading to learn more about how to create your CER according to MEDDEV and MDR requirements.
WHAT TO EXPECT IN THIS 4-PART SERIES
Part 1: Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency
Part 2: The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data
Part 3: Performing Data Analysis for Your Medical Device’s Clinical Evaluation
|Part 4: How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (this article)|
When you have a question about your medical device’s path to market, it’s always a good idea to start with the regulations and guidance that are readily available.
In this case, the European Union Medical Device Regulation (EU MDR) is the regulation that covers clinical evaluation. Article 61 of EU MDR requires every medical device manufacturer to document the clinical evaluation of their device in a CER. This requirement is expanded upon in Annex XIV Part A, which states:
The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
However, you may have noticed that EU MDR doesn’t go into much detail about what should actually go into the clinical evaluation report itself. For that, you’ll need MEDDEV 2.7.1 Rev 4. That’s the guidance document put out by the European Commission (EC) that covers clinical evaluation.
MEDDEV 2.7.1 Rev 4 states that your CER should outline the four different stages of clinical evaluation:
Stage 0 - Scope: The scope and context of the clinical evaluation, including the product being tested and any sizes or settings covered in the evaluation. This also includes an explanation of the technology the device is based on and any claims about its performance or safety.
Stage 1 - Identification of pertinent data: This may include any data generated by the manufacturer, including premarket clinical investigations, as well as data from literature.
Stage 2 - Appraisal of data: In this stage the data is appraised and the validity of each data set must be determined, as well as its relevance to the clinical evaluation and how heavily it should be weighed in the overall evaluation.
Stage 3 - Analysis of clinical data: This is the actual analysis of the clinical data, which should include the benefits and risks of the device, explain the acceptability of the benefit/risk profile, and address any residual risks, uncertainties, or unanswered questions.
In addition, MEDDEV 2.7.1 Rev 4 notes that your CER should contain sufficient information that external parties can read and understand it, stating:
Therefore, it should provide sufficient detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made and all conclusions reached.
This still leaves us with the practical question of how to write a clinical evaluation report. The MEDDEV guidance offers some general rules for writing your CER, saying:
The contents of the clinical evaluation report shall be cross-referenced to the relevant documents that support them. It should be clear which statements are substantiated by which data, and which reflect the conclusions or opinions of the evaluators. The report should include references to literature-based data and the titles and investigational codes (if relevant and available) of any clinical investigation reports, with cross-references to the location in the manufacturer’s technical documentation.
Additionally, in Appendix A9 of MEDDEV 2.7.1 Rev 4, you can find a proposed table of contents along with examples of what information your CER may contain. Keep in mind that every device is different and your CER may not be structured in exactly this manner.
Scope of the clinical evaluation
Clinical Background, current knowledge, state of the art
Device under evaluation
Type of evaluation
Demonstration of equivalence (if equivalence is claimed)
Clinical data generated and held by the manufacturer
Clinical data from literature
Summary and appraisal of clinical data
Requirement on performance
Requirement on acceptability of side effects
Date of next clinical evaluation
Dates and signatures
Qualification of the responsible evaluators
Finally, Annex 10 of MEDDEV 2.7.1 Rev 4 contains a checklist to help ensure you haven’t missed anything before you submit your CER.
Although compiling it may take plenty of effort, your work isn’t done once your clinical evaluation report is completed.
The CER is meant to be a living document, and if at any point you receive new and pertinent information about your device through postmarket surveillance or new clinical evaluations, then the CER must be updated to reflect that. However, even if you don’t receive new information, your clinical evaluation report must still be updated according to a schedule that you, the manufacturer, define and justify.
For devices that carry significant risk—Class III devices or Class IIb implantables—the CER must be updated every year. For devices without significant risk, the CER must be updated every two to five years. The schedule you choose should reflect the risk classification of your device and how well-established the technology behind the device is.
The guidance document MDCG 2020-6 provides a definition for well-established technologies, stating that they have:
relatively simple, common and stable designs with little evolution;
their generic device group has well-known safety and has not been associated with safety issues in the past;
well-known clinical performance characteristics and their generic device group are standard of care devices where there is little evolution in indications and the state of the art;
a long history on the market.
Though the choice of when to update the clinical evaluation report is left up to the manufacturer, you must be sure that you can justify your decision based on the risk classification of your device and the technology behind it.
The CER is incredibly important when it comes to obtaining a CE marking and selling your device in the EU. However, it’s not an easy document to construct and maintain.
You’ll be drawing on clinical data and sources from literature and cross-referencing those documents with the statements they support. It’s a lengthy and time-consuming process without the right tool to help you.
But it doesn’t have to be quite so difficult. With Intelligent Document Management from Greenlight Guru, you can keep all your clinical data and documentation in one place and be sure that everyone is working from the latest version. These are just a few of the many capabilities of the only purpose-built solution for medical devices.
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Niki Price is a Medical Device Guru who has spent her entire career working with different types of medical devices. She began her journey in production, which is where she discovered how important and fulfilling this line of work was to her! Spending time in both Quality and R&D, she enjoys the product development...