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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

Approval and revision history

Device information

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)

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

2. Manufacturer’s responsibility in handling the document

Manufacturers must ensure that the "Previous Generations and Similar Devices" document is:

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.

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