This is a common question from many of my clients:
“When do we need to update our CER?”
Because there was some confusion, the Medical Device Coordination Group (MDCG) issue a guideline on October 2021 to clarify some issues. This is literally what the MDCG guideline says:
"The manufacturer must update the clinical evaluation with clinically relevant information coming from post-market surveillance (PMS), in particular the post-market clinical follow-up (PMCF).”
"For implantable devices and class III devices, the manufacturer must update the PMCF evaluation report as it will serve an input for the writing of the Periodic Safety Update Report (PSUR); and, if indicated, the summary of safety and clinical performance (MDR Article 32)."
"For class IIa, IIb and III devices, the manufacturer must prepare a PSUR for each device (MDR Article 86). This report must be updated at least annually for Class IIb and III devices; and at least every two years for class IIa devices.”
What this means is, since the PSUR needs to be updated, then the CER needs to be updated accordingly.
As soon as there’s new information from the PMS/PMCF, then the CER needs to be updated (even if it is less than a year) - it all depends on the information triggered by PMS/PMCF.
In theory, the CER would be valid for 2-5 years if the device would not carry significant risks, and was well established. But with the new regulations, the risk-benefit needs to be assessed as soon as there’s a new risk triggered by PMS/PMCF, or yearly according to the obligatory-yearly-updated PSUR (Class IIb and III), or every two years (Class IIa).
All in all, if not red-flags are raised, no major changes will be needed to the CER; probably, some minor changes to the performance literature based on the upcoming articles related to similar devices that are currently in the market. So, in terms of costs, the budget to update the CER will be smaller than writing a CER from scratch - this, if no design changes were made to the device or no risk-safety triggers were raised.
In summary, according to the regulation the clinical evaluation is actively updated under two occasions:
- When the manufacturer receives new information from Post-Marketing Surveillance (PMS), in particular from the Post-market Clinical Follow-Up (PMCF), that has the potential to change the current evaluation (which could happen at any moment since the device is actively being used in the market);
- If NO PMS information is received, then the CER needs to be updated:
- 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 – of course, a justification should be provided.
When the involvement of notified bodies (NB) is required, updates are usually coordinated with the NB. Typically, they are aligned with the timetable for surveillance audits and the renewal of the certificates.
Furthermore, your regulatory team responsible for PMS/PMCF, needs to pay attention to whatever information is coming from the market and its EUDAMED database.
by Catarina Carrão
(aka Ana Catarina Ribeiro Carrão)