Product Release
List Of Medical Devices
Maintain comprehensive registry tracking all device versions and market availability throughout lifecycle.
Summary
The List of Medical Devices is a comprehensive registry that documents all current and previous versions of your medical device software, including version details, release dates, device identifiers, and market availability. This document serves as a master record for device lifecycle management and provides essential traceability information for regulatory authorities, customers, and internal quality management.Why is List of Medical Devices important?
This document provides complete traceability of your device versions throughout the entire product lifecycle, which is essential for regulatory compliance and post-market surveillance. Regulatory authorities require clear documentation of all device versions to track safety performance, manage recalls if necessary, and verify compliance with ongoing regulatory requirements. For manufacturers, this list enables systematic version management, helps identify which versions are still supported in the market, and provides critical information for customer support and technical assistance.Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Design history file (820.30) requires records of all design versions
- Device master record (820.181) must include version identification
- Change control (820.40) requires documentation of version changes
- Traceability (820.65) mandates device identification and tracking
Special attention required for:
- Software version tracking for post-market surveillance reporting
- Integration with FDA Establishment Registration and Device Listing updates
- Version control alignment with 510(k) submissions and amendments
- Recall management and version-specific safety communications
Guide
Current Device Information Management
Maintain accurate information about your current device version including the exact device name, current software version, release date, UDI-DI, and complete market availability information. This section should always reflect the most recent version available to customers and must be updated with each new release. Ensure consistency between this information and your device registration databases, technical documentation, and marketing materials.Version History Documentation
Document all previous software versions with complete details including version numbers, release dates, decommissioning dates when applicable, and associated device identifiers. This historical record is crucial for traceability, customer support, and regulatory compliance. Include information about when older versions were withdrawn from the market and any transition periods where multiple versions were simultaneously available.Market Availability Tracking
Clearly document which markets and countries your device is available in for each version. This information is essential for regulatory compliance, as different markets may have different approval timelines and requirements. Update this information when you gain market access in new countries or when regulatory status changes in existing markets. Consider including specific regulatory approval dates for major markets.Device Identifier Management
Maintain accurate UDI-DI information for each device version, ensuring consistency with regulatory databases and labeling. Each software version may have a different UDI-PI while sharing the same UDI-DI, so document these relationships clearly. This information is critical for regulatory traceability and post-market surveillance activities.Similar Device Documentation
Include information about similar marketed devices that may be relevant for regulatory comparison, competitive analysis, or clinical evaluation purposes. This can include predicate devices used for FDA submissions, similar devices in your product portfolio, or competitor devices that serve similar clinical purposes. This information supports regulatory strategy and market positioning.Lifecycle Status Management
Track the lifecycle status of each device version including active, deprecated, or decommissioned status. Document support timelines, end-of-life dates, and migration paths for customers using older versions. This information helps manage customer relationships and ensures appropriate support for devices still in clinical use.Integration with Quality Management
Ensure your device list integrates with your quality management system and change control processes. Each new version should be added through your established change control procedures, and the list should be updated as part of your software release process. This ensures consistency between your device registry and other quality documentation.Example
Scenario
You are maintaining the device list for your telemedicine platform that provides remote patient monitoring and consultation services. The platform has evolved through several versions with different feature sets and market availability, and you need to track all versions for regulatory compliance and customer support.Example List of Medical Devices
1. Scope
This document describes the latest device details and as well as details for previous device versions for TeleCare Pro remote patient monitoring platform.2. Current Medical Devices
| Device Name | Current Version | Release Date | Device Identifier | Markets / Countries Available |
|---|---|---|---|---|
| TeleCare Pro | 5.2.1 | April 10, 2024 | (01)04012345678901 | Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United States |
3. Previous Versions
| Device Name | Device Version | Release Date | Decommissioning Date | Device Identifier | Markets Available | Support Status |
|---|---|---|---|---|---|---|
| TeleCare Pro | 5.2.0 | February 15, 2024 | April 10, 2024 | (01)04012345678901 | EU, US | Superseded |
| TeleCare Pro | 5.1.3 | December 8, 2023 | February 15, 2024 | (01)04012345678901 | EU, US | End of Support |
| TeleCare Pro | 5.1.2 | October 22, 2023 | December 8, 2023 | (01)04012345678901 | EU, US | End of Support |
| TeleCare Pro | 5.1.1 | September 5, 2023 | October 22, 2023 | (01)04012345678901 | EU, US | End of Support |
| TeleCare Pro | 5.1.0 | July 18, 2023 | September 5, 2023 | (01)04012345678901 | EU, US | End of Support |
| TeleCare Pro | 5.0.2 | May 30, 2023 | July 18, 2023 | (01)04012345678901 | EU, US | End of Support |
| TeleCare Pro | 5.0.1 | April 12, 2023 | May 30, 2023 | (01)04012345678901 | EU, US | End of Support |
| TeleCare Pro | 5.0.0 | February 28, 2023 | April 12, 2023 | (01)04012345678901 | EU, US | End of Support |
4. Similar Devices
| Device Name | Manufacturer | Market | Regulatory Status | Clinical Purpose | Comparison Notes |
|---|---|---|---|---|---|
| RemoteHealth Monitor | HealthTech Solutions | EU, US | CE marked, FDA cleared | Remote patient monitoring | Predicate device for FDA 510(k) submission |
| VitalWatch Pro | MedDevice Corp | EU | CE marked | Patient vital signs monitoring | Similar monitoring capabilities, different user interface |
| CareConnect Platform | Digital Health Inc | US | FDA cleared | Telemedicine consultations | Similar consultation features, no monitoring component |
| PatientLink Remote | TeleMed Systems | EU, Canada | CE marked, Health Canada approved | Remote monitoring and consultation | Direct competitor with similar feature set |
Q&A
How often should I update the list of medical devices?
How often should I update the list of medical devices?
Update the list with every software release to reflect new versions, and review it regularly to ensure market availability information remains current. Also update when devices are decommissioned or when market access changes in different countries.
What should I do with very old device versions that are no longer supported?
What should I do with very old device versions that are no longer supported?
Keep historical records of all versions for regulatory traceability, but clearly mark their support status as “End of Support” or “Decommissioned.” Include decommissioning dates and any relevant safety or support information for customers who may still be using older versions.
How do I handle different versions available in different markets?
How do I handle different versions available in different markets?
Document market-specific availability for each version, as regulatory approval timelines may vary between countries. Some markets may still be using older versions while others have access to newer releases. Track this information carefully for regulatory compliance and customer support.
Should I include beta or pre-release versions in this list?
Should I include beta or pre-release versions in this list?
Generally no, include only commercially released versions that are or were available to customers. Beta versions should be tracked separately in your development documentation. However, if beta versions were provided to clinical sites for evaluation, consider documenting them separately with clear identification of their non-commercial status.
How does this list relate to my UDI database registrations?
How does this list relate to my UDI database registrations?
Ensure consistency between your device list and UDI database registrations. Each version should have corresponding UDI-PI entries in regulatory databases, and any changes to market availability should be reflected in both your internal list and regulatory registrations.
What information should I include about similar devices?
What information should I include about similar devices?
Include devices that are relevant for regulatory comparison (like predicate devices), competitive analysis, or clinical evaluation purposes. Focus on devices with similar intended use, clinical purpose, or technological approach. This information supports regulatory strategy and market positioning activities.