1. Overview
This document provides details about the current medical device version, along with information on prior versions.
Regulatory References:
- MDR Annex II Para. 1.2
This template is designed to guide the structure and content of your documentation. It is best maintained in a spreadsheet or Excel format. Consider each section as a separate tab or sheet.
2. Current Medical Device Version
Complete the table below for each installed version of the device. For example, in a B2B context, use one row to document the device installation at each customer site.
| Device Name | Product Status | Release Date | Purpose | Device Identifier (DI) | Product Identifier (PI) | Customer Details | Customer Point of Contact | App Store URL | Commentary |
|---|---|---|---|---|---|---|---|---|---|
| \ |
\ |
(…) | \<e.g., clinical use> | (…) | (…) | (…) | (…) | (…) | (…) |
3. Previous Versions
Use the table below to record the version history of the device.
| Device Name | Device Version | Release Date | Decommissioning Date | Device Identifier (DI) | Product Identifier (PI) | Commentary |
|---|---|---|---|---|---|---|
| \ |
V.1.1 | (…) | (…) | (…) | (…) | (…) |
| \ |
V.1.0 | (…) | (…) | (…) | (…) | (…) |
4. Comparable Devices
| Product Name | Manufacturer | Country of Origin | Additional Information | Device Identifier (DI) |
|---|---|---|---|---|
| \ |
(…) | (…) | (…) | (…) |