How often should Clinical Evaluation Report (CER) be updated?

As per the MDR, clinical evaluations must be duly updated to ensure they reflect the latest data and maintain compliance. However, the MDR does not specify a fixed frequency for these updates. A common question arises: how often should a clinical evaluation be updated?

Should I take a conservative approach updating the CER?

The primary guidance for clinical evaluation has long been MEDDEV 2.7/1, which is supposed to provide insights into best practices. How does it address the frequency of updates? Let’s explore this guidance to understand its recommendations and how they can help determine when clinical evaluations should be reviewed and revised.

First and foremost, MEDDEV 2.7/1 states that manufacturers must define and justify the frequency of clinical evaluation updates. Updates are required when new information from Post-Market Surveillance (PMS) warrants it or when the product has been modified.

In all other cases, MEDDEV 2.7/1 recommends the following update intervals:

• At least annually for devices carrying significant risks or those not yet well established.
• Every 2 to 5 years for devices with no significant risks and that are well established, provided a justification is documented.

Or should I look into logic of the MDR and take a more innovative approach?

Despite the above, MEDDEV 2.7/1 was introduced under the MDD framework, which did not mandate the robust and methodical Post-Market Clinical Follow-up (PMCF) processes required by the MDR. The purpose of PMCF is to continuously update clinical data without altering the existing Clinical Evaluation Report. Essentially, it builds upon the existing CER by incorporating new clinical information collected during the reporting period. Therefore, regular updates to the Clinical Evaluation Plan and CER are often unnecessary, as the PMCF plan and periodic PMCF reports serve to fulfill this role.

Here is what MDR says about PMCF: "PMCF shall be understood to be a continuous process that updates the clinical evaluation [...] When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking [...] with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence."

So it seems updating CER is redundant

In other words, PMCF takes over the role of updating the CER, making regular updates to the CER itself unnecessary. PMCF ensures that new clinical data is continuously collected and documented, effectively performing the function of keeping the evaluation current.

Hence, the modern approach under MDR emphasizes maintaining a robust PMCF system to continuously gather and analyze clinical data. Updates to the CER are typically only required if there are significant changes to the device or if Post-Market Surveillance data reveals information that warrants a formal update.

But there is always a but...

Although this no-updates-to-CER approach aligns with MDR and follows a logical, modern framework, it may be too progressive for some Notified Bodies and Competent Authorities, which might adhere to more traditional practices. To play it safe, consider discussing this approach with them beforehand. Additionally, you could include in your Quality Management System a commitment to update the CER at least once every five years, as recommended in MEDDEV 2.7/1, which remains broadly recognized as valid under the MDR framework.