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Medical Device: IMDRF guidance aims to harmonize, streamline review reports

2023/03/01  RAPS

The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not just for medical device sponsors but also for reviewers to improve consistency and reduce burdens for companies bringing products to different markets.

In early February, IMDRF published a final guidance entitled, Medical Device Regulatory Review Report: Guidance Regarding Information to be Included. The document applies solely to medical device, and not to in vitro diagnostics, and is part of a set of guidances the group has produced to harmonize the medical device review process across regulatory jurisdictions.

IMDRF said its guidances Competence, Training, and Conduct Requirements for Regulatory Reviewers and Requirements for Medical Device Conformity Assessment Bodies for Regulatory Authority Recognition are meant to be complimentary guidances, and it lists several other documents that may be applicable.

“The scope of this guidance document is limited to the information participating IMDRF Regulatory Authorities require in medical device regulatory review reports, the format of reports, and the information necessary for participating IMDRF [regulatory authorities] RAs to effectively use the regulatory review reports in accordance with their legislation and regulations,” the guidance states. “This document is intended to identify the type of information a [Conformity Assessment Body (CAB)] would be expected to review during evaluation of a regulatory submission.”

While IMDRF said the document doesn’t apply to any specific regulatory authorities (RA), some RAs may decide to use the document to help them when considering regulatory submission.

A key aspect of the review reports according to IMDRF should be documenting the CAB’s evaluation. The evaluation should include information such as relevant information submitted to the CAB for review by the sponsor, documenting the CAB’s final opinions every step of the way and providing a rationale for why the information provided was or wasn’t sufficient for reviewers.

“[The CAB’s] evaluation should not include a detailed listing and history of all interactions with the manufacturer on a specific topic,” the guidance states. “Questions sent to the manufacturer by the CAB and responses (including data and corrective action plan(s)) provided by the manufacturer to address the CAB’s concerns should be either provided as an appendix of the report or maintained as a separate resource available to support the conclusions of the regulatory review.”

The guidance’s core lists information that regulators from different jurisdictions have agreed need to be included in the review reports. It also includes details about the CAB, the scope of the regulatory review of the sponsor’s product, regional administrative details, supporting non-clinical and clinical evidence and details on the labeling and promotional materials to be used.

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