February 21, 2023

EU MDR Clinical Evaluation Report (CER) Frequency

The EU MDR doesn’t prescribe the frequency at which CERs are to be updated.  Modeling this, the MDCG (2020-13) has left manufacturers the liberty to, “…Identify when updates to the clinical evaluation report shall be assessed during the surveillance and post certification monitoring activities and which frequency should be considered…”.  Consequently, the frequency of updates is generally up to the manufacturer’s discretion. Yet that must be appropriate risk-based discretion.

While MEDDEV 2.7/1 revision 4 gives specific guidelines (specifically, update at least annually if the device carries significant risks or is not yet well established; or every 2 to 5 years if the device is not expected to carry significant risks and is well established), we need to remain sensitive to the fact that MEDDEV 2.7/1 isn’t generally intended for the EU MDR.  Nonetheless, for now, the Notified Bodies and other Union authorities are still often generally tolerant of that MEDDEV in my experience as along as its prescription is reasonable for the subject device.  Otherwise, the manufacturer is required to tailor the frequencies to its particular device scenario.