Post-Market Surveillance (PMS, PMCF, PMPF)
Certification is not the finish line. The EU MDR and IVDR require manufacturers to actively monitor devices in the field for their entire market life, and post-market performance is now visible to regulators and directly affects certification renewal. EvySaif builds the post-market surveillance documentation that keeps your evidence current and your certification secure.
The post-market system, structured
Under MDR Articles 83 to 86 and Annex III (and the IVDR equivalents), the Post-Market Surveillance (PMS) plan is an integral part of the technical documentation and must describe a proactive, systematic process for collecting and acting on field data, with defined indicators and thresholds for reassessing the benefit-risk balance.
Plan the surveillance
The PMS plan describes a proactive, systematic process with defined indicators and thresholds for reassessing benefit-risk. The outputs depend on risk class, and the plan is part of the technical documentation.
Meet the reporting cadence
For Class I devices and lower-risk IVDs, a PMS report must be available on request. For higher classes, a PSUR is required: at least every two years for Class IIa devices and Class C IVDs, and at least annually for Class IIb and Class III devices and Class D IVDs. MDCG 2022-21 and MDCG 2025-10 set the expectations.
Run PMCF and PMPF
Post-Market Clinical Follow-up (MDR Annex XIV Part B) and Post-Market Performance Follow-up (IVDR Annex XIII Part B) proactively collect new data. Where PMCF is concluded not needed, a written justification is required, and vague justifications are a frequent source of findings.
Summarize and feed back
For higher-risk devices this feeds the Summary of Safety and Clinical Performance (SSCP) and the Class C and D IVD equivalent, and all of it flows back into the CER or PER. Vigilance reporting of serious incidents runs in parallel.
How we treat it: post-market work is the continuation of the clinical and performance evidence, not a box-ticking afterthought. Our documentation connects field data back to the benefit-risk case, the joined-up story Notified Bodies reward at renewal.
What we prepare
PMS plans and reportsPost-Market Surveillance plans and reports, part of the technical documentation.
PMCF and PMPFPlans and reports, with PMCF-not-required justifications where applicable.
PSURsPeriodic Safety Update Reports at the required cadence.
SSCP and IVD summariesSummary of Safety and Clinical Performance and Class C/D IVD summaries.
Feedback into CER or PERIntegration of post-market data back into the evaluation.
Annex III gap analysisPMS gap analysis against MDR and IVDR Annex III.
How EvySaif helps
We build the post-market documentation that keeps your evidence current and your certification secure. We plan proactive surveillance, meet the PSUR cadence for your risk class, write defensible PMCF and PMPF, and feed the findings back into the CER or PER.
Why EvySaif
EvySaif is one of the best research and medical writing consultancies in India, and we treat post-market work as the continuation of the clinical and performance evidence, not a box-ticking afterthought. Our clinician-led documentation connects field data back to the benefit-risk case, which is exactly the joined-up story Notified Bodies now expect and reward at renewal.
Frequently asked questions
For Class IIa devices and Class C IVDs, at least every two years. For Class IIb and Class III devices and Class D IVDs, at least annually. Class I devices need a PMS report on request.
PMCF is the post-market clinical follow-up for medical devices (MDR Annex XIV Part B); PMPF is the post-market performance follow-up for IVDs (IVDR Annex XIII Part B). Both keep the clinical or performance evidence current.
Yes. Keeping the CER or PER updated with post-market findings is a core part of what we deliver.
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