PSUR: Periodic Safety Update Reports under EU MDR

EU MDR deliverable

What the PSUR has to contain

Article 86 of EU MDR 2017/745 requires manufacturers of Class IIa, IIb and III devices to prepare a Periodic Safety Update Report for each device, or each category or group of devices. It is the document in which you set out what the post-market data showed over the period and what you concluded from it.

The regulation names what must be in it: the conclusions of the benefit-risk determination, the main findings of PMCF, the volume of sales, an estimate of the size and other characteristics of the population using the device, and where practicable the usage frequency. A PSUR that reports complaints without reaching a benefit-risk conclusion has missed the point of the document.

Frequency and who sees it

  • Class III and implantable devices — updated at least annually, and submitted to the notified body through EUDAMED. The notified body reviews it and adds its evaluation.
  • Class IIb devices — updated at least annually, made available to the notified body and competent authorities on request.
  • Class IIa devices — updated at least every two years, available on request.
  • Class I devices — no PSUR. A Post-Market Surveillance Report under Article 85 is required instead, and we prepare those on the same footing.

What we produce

  • A PSUR structured to Article 86 and MDCG guidance, so the reviewer finds each required element where they expect it.
  • Sales and exposure data converted into a denominator that makes complaint and incident rates meaningful, rather than raw counts that say nothing about frequency.
  • Trend analysis under Article 88, with the statistical method and the threshold for a significant increase stated in advance.
  • Integration of vigilance data, field safety corrective actions, complaint handling output, PMCF findings and literature.
  • An explicit benefit-risk conclusion, consistent with the CER and the risk management file, plus the preventive and corrective actions arising.
  • Device grouping rationale where one PSUR covers a family, which the notified body will test.

Where PSURs go wrong

  • No denominator. “Fourteen complaints this year” means nothing without units sold and an estimate of use. Rates, not counts.
  • The three documents disagree. A PSUR concluding the benefit-risk is unchanged, next to a risk file that was revised, next to a CER that was not, is the fastest route to a major nonconformity.
  • Trending defined after the fact. Article 88 expects a pre-defined method and threshold. Deciding what counts as a significant increase once you have seen the data is not trending.
  • Grouping for convenience. Devices grouped into one PSUR because it is less work, rather than because they share a risk profile and intended purpose.
  • Prepared but never actioned. The PSUR must state what changed as a result. If nothing changed, say why.

How the work runs

We set up the data collection first — which systems feed the PSUR, who owns each input and on what cadence — because most of the pain in a PSUR is assembling data that was never structured for it. Then we write the report, reconcile its conclusions against the CER and the risk file, and prepare the EUDAMED upload where the class requires it. For manufacturers with several device families we build one template and a schedule, so the annual cycle becomes routine rather than a scramble.

Frequently asked questions

Do Class I devices need a PSUR?
No. Class I manufacturers prepare a Post-Market Surveillance Report under Article 85, which is lighter but still required and still expected to reach conclusions.

Can one PSUR cover a whole product family?
Yes, for a category or group of devices, provided the grouping is justified by shared intended purpose and risk profile. The justification belongs in the document.

Where is the PSUR submitted?
For Class III and implantable devices, to the notified body via EUDAMED. For Class IIa and IIb it is made available to the notified body and competent authorities on request.

What happens if the PSUR shows a rising trend?
Article 88 requires reporting a statistically significant increase in non-serious incidents or expected side effects to the competent authorities, and the PSUR must record the action taken.

How long must we keep it?
As part of the technical documentation: at least ten years after the last device was placed on the market, and fifteen years for implantable devices.

The PSUR is part of the technical documentation behind your CE marking, and we can run the annual cycle as an ongoing engagement.