A clinical evaluation report (CER) is a key supporting document in the steps to obtaining a CE mark. Whilst the initial CER is required at the start of the device lifecycle, many manufacturer’s often don’t appreciate that the report is a ‘live’ document and it must be updated periodically.
Updates should be based on ongoing clinical evaluations, or as part of the post-market surveillance and vigilance activities.
A CER should be updated:
- Every year, or…
- When new information from post-market surveillance is identified that has the potential to impact the current evaluation and/or risk-benefit analysis, or…
- Every 2-5 years if the device is considered ‘low risk’ and is well established on the European market.
Speak with a specialist within the medical devices team at Regulis if you require assistance in updating your device CER according to the new MEDDEV 2.7.1 rev 4 requirements.