Every medical device sold into Europe must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. Unfortunately, available guidance on the clinical evaluation requirements isn’t comprehensive, a lack of clarity that can lead to uncertainty for manufacturers as to whether their CER procedures will be considered compliant and their medical devices adequately supported.
To eliminate confusion and ensure the next review of their Technical File by Notified Bodies goes smoothly, medical device manufacturers should revisit their procedures for producing compliant clinical evaluations.
A helpful resource for producing compliant CERs and protecting your firm from the consequences of non-compliance, this step-by-step guide
- Highlights common sources of non-compliance
- Clarifies requirements and addresses gaps in clinical evaluation guidance
- Helps manufacturers attain compliance and prepare for future regulatory changes