IMDRF Releases the 2026 Edition of Terminologies for Categorized Adverse Event Reporting (AER Terms)

Source Information

• Source organization: IMDRF (International Medical Device Regulators Forum)
• Original publication date: 3 March 2026
• Original link: https://www.imdrf.org/documents/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes

IMDRF has published the 2026 edition of its terminologies for categorized adverse event reporting, continuing to promote the harmonization of terminology and coding for global post-market surveillance.

Full Translation of the Core Content

According to the IMDRF document page, the 2026 edition of the adverse event reporting (AER) terminologies was published on 3 March 2026 and is presented as a consolidated workbook, with each annex set out as a separate table. The AER terms and codes are intended to help regulators, manufacturers and industry use more consistent classifications of events, causes, impacts and components when reporting adverse events.

The value of harmonized adverse event terminology lies in improving the comparability of post-market surveillance data worldwide. For companies selling in multiple countries, complaints and adverse events may originate from different countries, distributors, hospitals and user channels. Where terminology and coding systems are inconsistent, it becomes difficult for companies to conduct trend analysis, identify risk signals, manage CAPA and prepare global regulatory reports.

The IMDRF AER terms provide a reference for companies establishing international complaint and adverse event databases, and they also support post-market data management in markets such as the EU under MDR, Australia under the TGA, Canada under Health Canada and Singapore under the HSA.

AIMEILI Regulatory Interpretation

In AIMEILI's Regulatory Affairs Department's view, updates of this kind reflect a shift in global regulation from pre-market market access toward transparent lifecycle management. UDI, EUDAMED, SSCP, adverse event terminology and electronic reporting systems may appear to belong to different regulatory modules, but they all point to a single requirement: once a product is on the market, it must be identifiable, traceable, updatable and publicly explainable, and the company must be able to demonstrate continued compliance through structured data.

For companies, this is not a matter of a single label field or database account. It is an integrated engineering task spanning registration dossiers, packaging labels, ERP codes, distributor management, PMS plans, complaint handling, recall processes and certificate maintenance. If the model listed on the registration certificate, the identifier on the label, the product information in the database, the terminology used in post-market reports and the distributor's actual sales territory are inconsistent, risks will arise during subsequent reviews, recalls or certificate renewals.

AIMEILI recommends that companies establish a global product master data table as early as possible, covering at a minimum the product name, model and specifications, intended use, risk class, certificate number, UDI or traceability code, label version, countries of sale, local responsible entity and post-market reporting requirements. In markets such as the EU, Australia, the United States, Canada and Singapore, product data governance capability will increasingly affect a company's registration efficiency and its ability to maintain a continuous market supply.

Business Impact

For companies selling in multiple countries, post-market surveillance data often come from different countries, distributors, hospitals and customer service channels. Where terminology and coding systems are not unified, trend analysis, risk signal identification and global CAPA management become difficult. The IMDRF AER terms provide a reference for companies building international complaint and adverse event databases.

The practical impact extends beyond adverse event reporting itself. Consistent use of AER terminology supports the alignment of complaint intake forms, vigilance reporting workflows, CAPA records, PSUR and PMS documentation, and distributor reporting templates. Companies that embed a common terminology structure into their quality management system and IT systems will be better positioned to respond to regulatory queries, generate comparable trend data across markets and demonstrate compliance in audits and inspections.

Recommended Compliance Actions

• Confirm whether this update affects existing registration pathways, certificate maintenance or post-market obligations.
• Verify the technical documentation, labels and instructions for use, quality system and local responsible entity arrangements in the target countries.
• Establish a change impact assessment and a regulatory update tracking record for products already on the market.
• Where necessary, archive the official source document, the Chinese-language interpretation and internal action items to facilitate subsequent audits and project reviews.

Content author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI International Medical Device Registration Project Team. Source principle: priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references. Scope of application: this article is intended for preliminary understanding, documentation preparation and project planning, and does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.