IMDRF publishes regulatory reliance playbook, document on selecting adverse event terminologies

The International Medical Device Regulators Forum (IMDRF) has published two new documents to help regulators and sponsors harmonize adverse event terminology and support regulatory reliance across regulatory agencies. The international group stated that regulatory reliance may help streamline activities by leveraging trusted regulatory authorities and that harmonizing adverse event terminology can help regulators detect safety signals sooner.

The idea for developing a regulatory reliance playbook was first proposed in 2024 at the IMDRF spring meeting in Washington, DC, when the US Food and Drug Administration (FDA) chaired the group. During the meeting, regulators from around the world discussed how they have used reliance as a mechanism to review products that other trusted regulators have already evaluated, enabling them to get products into their own markets faster. (RELATED: Stakeholders discuss potential IMDRF reliance playbook, guidance, Regulatory Focus 11 March 2024)

Regulatory reliance has been a hot topic among regulators, including the UK, where the Medicines and Healthcare Products Regulatory Agency (MHRA) is trying to be pragmatic with its resources and wants to learn from other regulatory partners when evaluating new products. MHRA CEO Lawrence Tallon has said that while Brexit and COVID-19 significantly disrupted the agency’s ability to review products coming to market, it has since recovered and is taking a pragmatic approach to regulating products, given its limited resources. (RELATED: MHRA leaders tout pragmatic approach to regulation post-Brexit, Regulatory Focus 17 June 2025)

IMDRF published the regulatory reliance playbook on 26 February. It details when regulatory agencies may consider relying on learnings from other regulatory agencies to regulate medical devices within their jurisdiction. The group noted that as technologies become more complex and the resources to regulate them become more constrained, regulatory reliance may help regulators in their decision-making by leveraging the work already done by trusted regulatory partners.

IMDRF said it published the regulatory reliance playbook to promote efficient and aligned approaches to developing regulatory reliance programs that build on existing regulatory reliance approaches. The group said its recommendations aim to ensure regulatory reliance strategies are sufficiently flexible to the user's regulatory regime and adaptable to their regulatory needs.

"This reliance playbook is written as guidance for regulatory authorities (RAs), both those embarking on their first reliance program and those aiming to enhance their existing program or create additional reliance frameworks," said IMDRF. "Although intended for regulators, this document is relevant to all medical device stakeholders."

IMDRF said that adopting reliance approaches could improve regulatory efficiency by reducing unnecessary duplication of work across regulators, optimizing resources by freeing them up, and reducing regulatory burdens for manufacturers. However, the group also said that reliance programs should offer concrete participation incentives, such as reduced review times.

There are three types of reliance that regulators may want to consider: work-sharing, which enables collaboration between regulatory authorities; an abridged regulatory pathway that can shorten reviews by relying on past regulatory assessments from trusted authorities; and recognizing another regulatory authority's decision with minimal to no review. However, before developing a reliance program, IMDRF stated that the regulator should assess their specific needs, whether their environment is ready to support the type of regulatory reliance they are considering, and their operating circumstances, including whether their domestic laws will allow reliance.

IMDRF also published an informational document on 26 February on selecting adverse event terminologies intended to help sponsors and regulators across jurisdictions reduce ambiguities in adverse event reports. The group said the aim of the document is to achieve harmonized coding of adverse event reports to improve signal detection by adverse event management systems, ultimately leading to faster and more coordinated responses from regulators across jurisdictions and manufacturers.

IMDRF noted that adverse event reports require the input of coded free-text information that describes the medical incident and has offered standardized terms organized into seven groupings within four sets of terminologies, each with its associated alphanumeric codes. It expects that all adverse event reports that use its document will include at least one code from each of the seven terminology groups.

The informational document provides a table of the four terminology groups, broken down into medical device problems, medical device components, health effects, and the cause of the investigation. They are also broken into subgroups that list types of codes from A codes to G codes. Furthermore, the document includes a diagram illustrating the sequence manufacturers should follow when using the codes.

"IMDRF codes follow a hierarchical structure where higher-level terms describe general issues, and lower-level terms provide specific details," said IMDRF. "Select the lowest-level term that accurately describes the issue.

"In the IMDRF coding structure, the more general terms comprise the entry level (i.e. Level 1)," the group added. "The more specific terms (Level 2, Level 3) nest within the Level 1 entries in that group."

When manufacturers are unable to find an exact match in the IMDRF terminology or don't have enough information to select the right code, the documents also provide three options to state that an appropriate term or code was not available, that there wasn't sufficient information, or that a part or component term was not available. The document stated that circumstances may require the code reported in the adverse event report to be updated, and in such situations, a new report should be provided.

Regulatory reliance playbook

Adverse events terminology technical document

IMDRF publishes regulatory reliance playbook, document on selecting adverse event terminologies

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