A drug PSUR isn't a device PSUR

Two statutes, one acronym

A device's PSUR is a creature of EU MDR Article 86, filed by the manufacturer to the notified body (or kept on file, for lower-risk classes) and built from post-market surveillance and vigilance data gathered under the device regulation. A medicinal product's PSUR is a creature of Directive 2001/83/EC Article 107b, filed by the marketing authorisation holder to the European Medicines Agency through its central repository. The two statutes were written for different products, by different committees, on different timelines, and neither cross-references the other's version of the same three-letter name — a team that inherits one PSUR template and relabels it for the other product line is borrowing a shape built for a different question.

One counts against a threshold; the other evaluates a balance

The device PSUR this blog already described totals incidents, trend data and corrective actions against thresholds the manufacturer sets in its own post-market surveillance plan — a counting exercise, structured around whether the numbers cross a line. Article 107b asks for something else: a periodic safety update report built on a scientific evaluation of the risk-benefit balance of the medicinal product, drawing on all available data including findings from unauthorised indications and populations, plus an estimate of the population exposed. One document asks whether a number got too high. The other asks whether the product's benefits still outweigh its risks, as a standing question that has to be re-argued, not just re-tallied, at every interval — a conclusion, not a tripwire.

The drug version already renamed itself in the guideline that defines its content

In 2012, ICH replaced its original PSUR guideline with E2C(R2), which restructured the report around that explicit benefit-risk evaluation and renamed it the Periodic Benefit-Risk Evaluation Report, or PBRER. EU pharmacovigilance legislation never changed its own label — Article 107b still calls the filing a periodic safety update report — but EMA's good pharmacovigilance practice guidance built on that article points PSUR authors to the PBRER format to satisfy it. The legal name and the content standard it has to meet now come from two different documents, which is exactly the kind of mismatch a template built from only one of them will miss, and exactly the kind of mismatch a reviewer who knows both documents will notice immediately.

Exemptions follow a different kind of risk on each side

Both regimes exempt some products from the routine requirement, but they draw the line in different places. The device rules this blog already covered scale PSUR frequency and depth to device risk class. Article 107b(3) exempts generics, well-established-use products, and homeopathic or traditional herbal medicinal products from the routine PSUR requirement — unless a marketing authorisation condition or a competent authority specifically asks for one anyway. A device's exemption tracks what the device itself can do to a patient. A drug's exemption tracks how settled the evidence behind the product already is, which means two products that pose comparable real-world risk can land on opposite sides of their own regime's PSUR line for reasons that have nothing to do with each other.

Where this meets the file

A periodic-report template that declares, in its own title block, which PSUR it is — the device version built on MDR Article 86, or the medicinal-product version built on Article 107b and ICH E2C(R2) — rather than one generic form standing in for both, is previewed in the launch catalog. If your team has already built a crosswalk between the two that this one is missing, the shelf takes that correction directly.