Technical documentation section 1. Device description and specifications:
1.8 Previous generations and similar devices
The "Previous Generations and Similar Devices" document is a key part of the technical documentation required under MDR 2017/745. It provides an overview of a medical device’s historical development and its relationship with similar or equivalent products available on the market. This document helps regulatory authorities, notified bodies, and other stakeholders assess the device’s compliance, innovation, and equivalence claims.
1. Structure of the document
The document generally follows a structured format that includes the following sections:
Document identification
- Title: "Previous Generations and Similar Devices"
- Unique Document ID
- Version number
- Effective date
Approval and revision history
- Details of the document’s originator, reviewer, and approver
- Version history indicating updates or changes
Device information
- Product name
- Manufacturer name and address
Previous generations of the device
If the device is a first-generation product, this section states that no prior versions exist. If the device has predecessors, a summary of previous iterations, key improvements, and changes is provided.
Similar products manufactured by the same manufacturer
Information on whether the manufacturer has marketed similar products in the EU or internationally. If no similar devices have been marketed, this is explicitly stated.
Similar and equivalent devices from other manufacturers (if applicable)
- Identification of comparable products from other manufacturers
- A table outlining similarities and differences based on key characteristics, such as:
- Intended use
- Device properties
- Critical characteristics
- Compatibility with other devices, accessories, operating systems, browsers etc.
- Regulatory approvals (e.g., MDR, FDA 510(k))
- Functional capabilities
Explanations of new characteristics and intended purpose (if applicable)
Justification of any new technological features or intended uses compared to similar or previous devices.
Conclusion
- Summary of the device’s development history and market positioning
- Statement on whether the device introduces new characteristics or remains within existing intended uses
2. Manufacturer’s responsibility in handling the document
Manufacturers must ensure that the "Previous Generations and Similar Devices" document is:
- Accurate and up-to-date - any technological changes, new product iterations, or modifications in intended use must be documented.
- Consistently reviewed - the document should align with the latest regulatory requirements and product developments.
- Confidentially handled - access should be limited to authorized personnel, as the document often contains sensitive commercial information.
- Available for regulatory assessment - the document must be included in the technical documentation for CE marking and made available to notified bodies or competent authorities upon request.
By maintaining a well-structured and detailed "Previous Generations and Similar Devices" document, manufacturers can facilitate regulatory approval processes and demonstrate the safety, performance, and compliance of their medical devices.
