Writing a Clinical Evaluation Report (CER) is a complex task. Throughout the process, manufacturers frequently discover that there are more documents and further analysis that they should have prepared. These tasks include fully defining the intended purpose of the device, completing thorough systematic reviews of both the scientific literature for ‘state of the art’ research and ‘pivotal’ (device specific) research as well as comprehensive vigilance database searches. To make life easier, we have created a short list of five essential principles to consider before starting a CER.
1. Carefully choose your clinical evaluation route (also referred as “Type of evaluation”). It is important to consider the clinical evidence options that are available for the evaluated device. Firstly, is there data available for the device or should equivalence device be used? If there is no equivalence device, are there similar devices? The type of data required when creating a CER will be dependent on the type of evaluation. Make use of the table in MDCG 2020-6 “Appendix III – Suggested hierarchy of clinical evidence for confirmation of conformity with relevant GSPRs under the MDR” [1] and find the most appropriate and straight-forward path to support the safety and performance of your device.
2. Define the evaluated device’s intended purpose. This definition relates to important sections for compliance with MEDDEV 2.7/1 rev. 4 [2] and Regulation (EU) 2017/745 (MDR) [3]. The following sub-sections should be included:
The exact medical indications (if applicable) – this would include the name of disease or condition, the clinical presentation, stage, severity, symptoms or aspects to be treated, managed or diagnosed.
The patient populations (adults / children / infants, other aspects) relevant to the device use.
The intended user of the device, for example, will it be used by a health care professional or care giver?
Does the device come in contact with any organs / parts of the body / tissues or body fluids? If so, describe in detail.
How long is the device in contact with the body? Describe in detail.
What is the frequency of applications? Are there any restrictions as to the number or duration of reapplications? Describe in detail.
Is the device in contact with mucosal membranes? What is the level of invasiveness? Is the device an implantation? Describe in detail.
Is the device single use or reusable. Describe in detail.
List the contraindications of the device.
List the precautions required by the manufacturer.
3. Use at least two databases for your literature search. PubMed and Cochrane are free databases for references and are the international gold standard. These two databases also provide a convenient method for downloading all the results of your searches. Exporting your results using a CSV format (Excel) is a simple and efficient way to organize your data.
4. Prepare all the relevant clinical-regulatory documents. The clinical evaluation process requires many additional clinical-regulatory documents with associated guidelines for each one. Follow the guidelines! Make sure to use all the guidelines, refer to the relevant MDR sections for the Clinical Evaluation Plan, including the Clinical Development Plan (Annex XIV Part 1, MDR) [3], MDCG 2020-7 for the Post-market Clinical Follow-up (PMCF) plan [4], and MDCG 2020-8 for the PMCF Evaluation Report [5].
5. On completing of the CER, check that all risks identified in the CER are mentioned and mitigated in the risk analysis. To be in the safe side, elaborate on mitigation methods in the requirement on safety analysis section in the CER.
Summary Writing a CER can be a complicated and time-consuming project. This task can be made easier by following the steps out outlined above: choose the most appropriate route of evaluation for your device; pay attention to carefully defining the evaluated device’s intended purpose; use at least two databases for your literature search; ensure that you have prepared all the required regulatory documents and finally, as you complete the CER make sure that all risks that were identified in the CER have been discussed and mitigated in the correct sections of the CER.
References 1. MDCG 2020-6 Regulation (EU) 2017/745: Clinical Evidence Needed for Medical Devices Previously CE Marked under Directives 93/42/EEC or 90/385/EEC A Guide for Manufacturers and Notified Bodies. 2020. 2. MEDDEV Guideline 2.7.1, Rev 4, 2016. Guidelines on Medical Devices. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. 2016. 3. Annex XIV Part 1, Section1, Medical Device Regulation (EU) of the European Parliment and of the Council 2017/745 5 April 2017. 4. MDCG 2020-7 Post-Market Clinical Follow-up (PMCF) Plan Template A Guide for Manufacturers and Notified Bodies. 5. MDCG 2020-8 Post-Market Clinical Follow-up (PMCF) Evaluation Report Template A Guide for Manufacturers and Notified Bodies.