A well-written Clinical Evaluation Report (CER) is a cornerstone to achieving and maintaining the CE mark. This is because the CER is the principal means of documenting that sufficient clinical evidence exists to support safety and clinical performance claims of a medical device to be placed on the EU market or one that is already on the market.
Although the MDR lists specific information that must be included in a clinical evaluation plan, very little information is provided on the contents of the CER itself. Instead, detailed information on CER content is currently provided in the EU 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), which is in the process of being updated to relate specifically to MDR requirements.
MEDDEV 2.7/1 Rev 4 provides definitions, the general principles of clinical evaluation, how the clinical evaluation should be performed, and the structure and contents of a CER. The MDR requirements for clinical evaluation closely mirror the guidance; however, differences exist and will need to be addressed to ensure compliance with 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 are insufficient resources for developing an MDR-compliant CER.
Donawa Lifescience can help you to:
- Evaluate existing CERs to determine their adequacy
- Develop CERs or revise existing CERs to meet MDR requirements
- Train your staff in the development of CERs that will meet EU regulatory expectations
