A well-written Clinical Evaluation Report (CER) has become a cornerstone in achieving and maintaining the CE mark. This is because the CER is the principal means of documenting that sufficient clinical evidence exists to support clinical safety and performance claims of a medical device to be placed on the European market or one that is already on the market. There are no details on how to develop a CER or the information that should be included in a CER in the medical devices directives. Instead, these details are provided in European guidance, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC” (MEDDEV 2.7/1 Rev 4).
The European guidance on clinical evaluation provides definitions, the general principles of clinical evaluation, how the clinical evaluation should be performed, and the structure and contents of a CER. It also provides information that Notified Bodies should consider when assessing clinical evaluations and how the assessment should be documented. The MDR requirements for clinical evaluation and how to develop CERs closely mirrors the guidance; however, differences exist and will need to be addressed when operating under the MDR.
Some companies encounter difficulties in developing CERs which satisfy the expectations of the Notified Body during conformity assessment, or Competent Authorities reviewing CERs during market surveillance. In some cases, there may be insufficient expertise for writing the CER. In other cases, expertise is available, but there is insufficient time for developing a CER based on the EU clinical evaluation guidance.
DLC can help you to:
- Evaluate existing CERs to determine their adequacy
- Develop CERs that will meet current requirements under the medical devices directives
- Develop CERs or revise existing CERs to meet MDR requirements
- Train your staff in the development of CERs that will meet EU regulatory expectations