CE Mark: Clinical Evidence Requirements

Preparing a Clinical Evaluation for a CE Mark is no small task. Having it rejected by reviewers, and doing it over again to correct deficiencies is not uncommon. Clinical evaluations are commonly problematic for industry. Improving the preparation process starts with tips from recent submissions.


A clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. The EU MDR requirements for clinical evaluations are outlined in 2017/945, but some manufacturers don’t have history with the process. They could be facing challenges and rejections by the reviewers.


A clinical evaluation must be performed by device manufacturers pursuing the CE Mark prior to marketing the device in the European Union. Clinical evaluations are also repeated periodically as new clinical safety and performance information about the device is obtained.


The manufacturer demonstrates the device achieves its intended performance and that the risks and any adverse events are minimized and acceptable when weighed against the benefits. Claims made about the device’s performance and safety are supported by suitable evidence.


With regard to postmarket activities, manufacturers are expected to implement and maintain surveillance programs that routinely monitor the clinical performance and safety of the device as part of their quality management system (QMS). The QMS should use data generated from safety reports, including adverse event reports, results from published literature, any further clinical investigations, and formal post market surveillance studies.


Collecting Data


The literature review must be complete, covering pre- and postmarket data and any clinical investigations. In collecting data, it’s helpful to capture screen prints of searches, including the search terms and exact logic used in the search. Boolean logics such as “AND” and “OR” show repeatability and help the reviewers in analyzing the resulting clinical evaluation. For published and digital literature, it’s common for thousands of data sources to be identified.


Data Evaluation: The Heavy Lifting in Clinical Evaluations


After collecting the data, the next step is assessing the content and determining whether the data should be considered for the clinical evaluation.


regulatory complianceA scoring table can be useful for determining whether to include data. For example, data scored on factors such as device equivalency, application equivalency, similarity of operator, and demographic equivalency can be helpful during the analysis.


For studies that pass the scoring table, each must be summarized on how they support the essential requirements (see sidebar “The Clinical Evaluation Process”). A common mistake is simply copying the conclusion of the study instead of how it relates to the essential requirements.


Case Study: Class II device for breast biopsies


The manufacturer of the existing CE Mark device changed notified bodies. The new NB alerted the firm to numerous deficiencies in the clinical evaluation. The manufacturer decided it was beneficial to submit a new clinical evaluation.


The data collection resulted in 2211 papers. After an extensive analysis and scoring system, 27 papers were included in the clinical evaluation. A summary table was prepared for the clinical evaluation, which featured each paper and outlined the support of the essential requirements. The resulting clinical evaluation was approved without deficiency within 22 hours of submission.


Insights from the Experts


The clinical evaluation must be recreatable by third parties based on the process and scoring system outlined in the report. If the notified body can’t recreate it, they have no recourse except to find deficiency.


Make it easy for the CE Mark reviewers to check off each step. Highlight what they’re looking for relative to what you’re covering. Refer to guidances and standards that come from trusted industry sources.


Common errors can include the following:

  • Missing inclusion or exclusion criteria
  • Omitting applicable papers
  • Summarizing papers instead of evaluating them. Although a summary is required, the more important (and often omitted) portion is to explain how the data support the essential requirements
  • Forgetting summary tables
  • Forgetting a concluding argument. Explain how the document fulfills the requirements for the clinical evaluation.




Clinical evaluations include the assessment and analysis of the medical device’s clinical data to verify its clinical safety and performance. The stages are well-defined but can be intensive. A thorough clinical evaluation can involve thousands of data sources and significant time for proper assessment. Manufacturers should submit evaluations that are recreatable and make it easy for reviewers to follow.



regulatory compliance

Complete article published on Medical Device and Diagnostic Industry.


About RCA’s Medical Device Consulting Services


The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.


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About Regulatory Compliance Associates


Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


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About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.


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Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.


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