Insights
Practical guidance on CER writing, CER remediation, PMS/PMCF, PSUR, SSCP, and Notified Body response documentation — written for RA/QA and clinical affairs teams.
Before a Notified Body raises formal comments, there are early indicators in your CER that a reviewer may push back on. Here is what to watch for and how to address it before submission.
Not every CER gap requires a full remediation. Understanding the difference between a targeted update and a full remediation helps teams prioritise time and budget correctly.
EU MDR requires post-market data to actively inform your Clinical Evaluation Report. This is how to build that feedback loop into your documentation lifecycle and avoid consistency gaps.
Receiving Notified Body comments on clinical evaluation is stressful and time-sensitive. A structured response approach — triage, gap mapping, evidence-based justification — is the fastest path to resolution.
A PMCF Plan that states "registry participation" or "literature review" without clear methodology and justification is unlikely to satisfy MDR requirements. Here are the gaps Notified Bodies flag most often.
A PSUR is not a data dump. It is a periodic structured argument that the benefit-risk balance remains acceptable in light of post-market evidence. Here is how to write it that way.
The Summary of Safety and Clinical Performance must work for two very different audiences: healthcare professionals and patients. Here is how to structure it so it works for both — and aligns with your CER.
Under EU MDR, clinical evaluation based solely on published literature faces increasing scrutiny — particularly for Class IIb and Class III devices. What else do you need, and when?