A Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1. Rev 4 Guidelines: A Case of X-Ray and ECG

A leading   international healthcare technology company specialising in High-Frequency X-Ray Imaging Systems, Critical Care, Dental Care, Primary Healthcare & Telemedicine devices. The company’s vision is to aid Primary Healthcare with products of International quality and performance at an affordable level to the rural population throughout the world. The company does that by combining the latest in technology with the simplicity of design, innovation and high performance for efficient patient care. The company’s products are designed to comply with international quality & safety standards such as UL, CE, FDA, ISO 13485, ISO 9001 and AERB. The Company approached us to provide complete CER Report Evaluation and Writing. 

The Challenges

The company sells their medical devices in Europe and to comply with regulations, a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1. Rev 4 Guidelines the client approached Pepgra, a Unit of Guires Ltd for updating and preparation of Clinical evaluation report for CE Marking from Revision 3 guidelines to MEDDEV guideline 2.7.1 [Revision 4] (June 2016). The clinical evaluation report is developed to meet the requirements of MDD/93/42/EEC and framework as per MEDDEV 2.7.1. Rev 4 Guidelines. The initial report shared by the client was with 5-10 pages and didn’t cover all the requirements as per the MEDDEV guidelines. We discussed with the client about the new revision and provided following understanding of the work that needed to be carried out to adhere to the recent guidelines.  

1. Literature Search Flow Chart
2. Bibliographic Search Flow Chart
3. Screening the articles for inclusion and exclusion criteria (Primary & Bibliographic),
   1. Primary Search Title Screening Summary
   2. Bibliographic Title Screening Summary
   3. Primary Search Abstract & Full Text Screening Summary
   4. Bibliographic Abstract & Full Text Screening Summary
4. Data Extraction of finally included articles
5. Data Appraisal of Clinical Data [A6]
6. Analyses of the Clinical data [A7]
7. Data Interpretation
8. Conformity assessment with the requirement on Safety [A7.1]
9. Conformity assessment with the requirement on Acceptable benefit/risk profile [A7.2]
10. Conformity assessment with the requirement on performance [A7.3]
11. Conformity assessment with the requirement on Undesirable Side effects [A7.4]
12. Conclusion
13. Annexure I – Citation details
14. Annexure-II – Device Description Per Study Details
15. Annexure III – Study details
16. Annexure-IV – Study Outcome

Our Strategy

Since Pepgra specialises in reviewing medical device clinical data and ensure that CER meets all European requirement, our team of Medical device experts had developed the clinical evaluation report set for the manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC. The report is fully compliant with  MEDDEV 2.7/1 Rev 4. Since its a transition from old to new, the key changes and clarifications in the new guidelines MEDDEV 2.7.1 Rev 4 have been discussed and addressed. For instance,

• Clause 6.2.3 requires the CER to be updated at least annually for high risk of new devices, and every 2 to 5 years for lower risks. A justification for the update frequency will be required.  
• Clause 6.4 mandates to report qualifications of authors and evaluators, including a relevant higher education degree and five years or ten years’ experience. All evaluators must now make a declaration of interest
• Specific and measurable objectives of the CER in terms of safety, performance and risk endpoints related to the essential requirements to be mentioned clearly.
• Clause 8.2 mandates companies to establish state of the art including establishment of the device, its claimed equivalent(s) and any benchmark or other similar devices, its claimed equivalent(s) and any similar devices
• Section 9.3.1 addresses factors which can affect scientific validity of different types of datasets including literature search and retrieval methods (Section 8 and Appendix 5), data appraisal and weighting (Section 9 and Appendix 6), and the analysis of data and demonstration of conformity (Section 10 and Appendix 7)
• Revision 4 requires equivalence specifically mentioning the design differences and their impacts on clinical safety and performance which needs to be described in detail
• Revision 4 also requires that the Notified Body challenge the manufacturers access to data and therefore will require a manufacturer to have a contract in place allowing access to data
•  Sufficient data on the clinical device
• Appendix 7 Risk-benefit analysis to demonstrate safety and performance.
• Post Market Surveillance (PM) and Post Market Clinical Follow Up (PMCF)

Our team of experts visited the site, collected all manuals to understand the technical requirements of the product. Several discussions were carried out to complete the report, and with ten iterations, the report was successfully prepared and delivered.

Our Outcome and Impact

The literature search is being carried out to identify published clinical data that helps to assist manufacturers in establishing acceptable performance and safety standards for the pertinent device, i.e., Mobile C-Arm Surgical X-Ray System. The data generated through the literature search is directly related to the device or the equivalent device. While conducting a literature review, reasonable effort is made to conduct a comprehensive and exhaustive search, and the published data is thereby selected and evaluated judiciously, based on the principle of contribution towards the device, in terms of both performance and safety against the risks.

Pepgra specializes in reviewing medical device clinical data.Contact us for more information about how we can help you comply with MEDDEV 2.7/1 rev 4 and perform literature reviews.