How to Code an MDR Adverse Event Report

General Instructions

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In general, reporters are expected to provide at least one code for each adverse event code field that is relevant to their MDR. Note that this applies only to mandatory MDR reporting, which uses the 3500A form.

When prompted, reporters should select the lowest level, most detailed code or codes necessary to describe the event. Each parent code in the hierarchy is considered to be a set containing all of its child codes, so there is no need to choose both a parent and one of its children – the child code alone is sufficient. Depending on the submission method, the mechanics of how the reporter will choose the code will be different. For more information, see the Submission Methods section below.

There are two distinct coding scenarios; one is for manufacturers, and the other is for importers and user facilities. Depending on the type of reporter, the section of the 3500A where codes are entered and the code types required will be different.

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Submission Methods

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The process of selecting and entering the adverse event codes in an MDR depend upon the submission method used by the reporter. Although two reporters may be the same type of entity (for example, both manufacturers), the process of reporting differs depending on the submission method. This section outlines the process of entering adverse event codes for each possible submission method.

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提交方式：Paper、 eSubmitter、 AS2 XML

* 提交方式的详细内容及以上内容可通过以下FDA链接进行确认。

 

 

How to Code MDR Adverse Events

 

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