Post-Market Surveillance Under EU MDR: PMS Plans, PSURs, and PMCF Without the Overwhelm
Quick answer: EU MDR Articles 83–86 require every manufacturer — all device classes — to run a documented, proactive post-market surveillance system proportionate to risk class and device type. The deliverables: a PMS plan per device (Article 84, Annex III), a PMS report for Class I (Article 85), and a PSUR for Class IIa and above (Article 86) — updated at least every two years for Class IIa, annually for Class IIb and Class III. PMCF (post-market clinical follow-up, Annex XIV Part B) feeds clinical data into the cycle. Vigilance (Articles 87–91) is the reactive counterpart.
Why PMS is now a system, not a file
Under the old MDD, post-market surveillance was often a complaint log and good intentions. MDR made it an active data collection system: your PMS plan must specify data sources (complaints, field data, literature, registries, similar devices on the market), indicators and threshold values that trigger action, and methods connecting findings back to the risk management file, clinical evaluation, and — where needed — corrective action. Notified bodies read PMS documentation as a test of whether your whole QMS is alive.
The deliverables by device class
Class I — PMS report (Article 85); updated as necessary and kept available for the competent authority; no notified body review.
Class IIa — PSUR (Article 86); updated at least every two years; available to the notified body.
Class IIb — PSUR; updated annually; available to the notified body.
Class III and implantables — PSUR; updated annually; submitted to the notified body for evaluation (via EUDAMED once functional).
The PSUR must present: conclusions of the benefit-risk determination, main findings of PMCF, sales volume and user population estimates, and — where applicable — findings that trigger updates to the clinical evaluation, risk file, or IFU.
PMCF: the part everyone underestimates
Post-market clinical follow-up (Annex XIV Part B) is a continuous process to confirm safety and performance across the device's lifetime. A compliant PMCF plan specifies methods (surveys, registries, follow-up studies, literature review), a rationale for their appropriateness, and evaluation of the data against the clinical evaluation. "PMCF: not applicable — sufficient clinical data" needs a justification that survives scrutiny, and for most Class IIa+ devices it doesn't.
How small manufacturers run PMS sustainably
The workload is real but schedulable. A sustainable pattern: a quarterly PMS data sweep (complaints, literature search, incident databases, field feedback) against the plan's indicators; an annual (or biennial for IIa) PSUR production cycle timed to your certification calendar; and PMCF activity that piggybacks on existing customer contact where methodologically defensible. The critical design decision is realistic threshold values — thresholds set arbitrarily generate either false alarms or, worse, an auditor asking why a signal didn't trip one.
This is also the workload most commonly outsourced: an external RA/QA partner (or external PRRC, who must verify PMS compliance anyway under Article 15(3)(c)) runs the sweeps and drafts the PSURs, while product decisions stay with you.
Frequently asked questions
Does a Class I device really need PMS? Yes — a PMS system and plan per Articles 83–84, plus a PMS report kept available for the competent authority. Only the PSUR obligation is class-dependent.
What's the difference between PMS and vigilance? PMS is proactive, continuous data collection; vigilance is the reactive reporting of serious incidents and field safety corrective actions (Articles 87–91) on statutory deadlines.
Who signs off the PSUR? The PRRC verifies post-market surveillance obligations are met — the PSUR is central evidence of that verification.
Can PMS be outsourced? The activities, yes; the responsibility, no. The manufacturer's PMS plan and QMS must control the outsourced process.
About QLE Group
QLE Group designs and operates post-market surveillance systems — PMS plans, PSUR production, PMCF programmes, and vigilance readiness — as ongoing infrastructure for MedTech manufacturers, integrated with PI-insured external PRRC mandates. Delivered from Brussels by Radoslav Milkov (qualified PRRC, ISO 13485 / 21 CFR 820 Lead Auditor, LL.M. EU Law). Complexity-indexed pricing at qle.be.
PMS overdue for attention? Book a scoping call or email info@qle.be.
