Template: List of Medical Devices

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1. General Information

This document describes the latest device details and as well as details for previous device versions.

Regulatory references:

  • MDR Annex II Para. 1.2

Use this template to give you an idea of the necessary structure and contents. Ideally, this documentation is maintained best in a spreadsheet / excel file format. Think of every heading as a separate sheet / tab.

2. Current Medical Device Version

Fill out the table below for every installed device version. For example (in B2B business), use one row to describe every customer site the software device is installed at.

Device NameProduct StatusRelease DatePurposeDevice Identifier (DI)Product Identifier (PI)Customer DetailsCustomer Point of ContactApp Store URLCommentary
<enter device name><released / in trial / etc.>(…)<e.g. clinical use>(…)(…)(…)(…)(…)(…)

3. Previous Versions

Use the table below to document your device’s versions history.

Device NameDevice VersionRelease DateDecommissioning DateDevice Identifier (DI)Product Identifier (PI)Commentary
<enter device name>V.1.1(…)(…)(…)(…)(…)
<enter device name>V.1.0(…)(…)(…)(…)(…)

4. Similar Devices

Product NameManufacturerCountry of OriginAdditional InformationDevice Identifier (DI)
<enter device name>(…)(…)(…)(…)

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

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