British Standards Institution

Source:: IEC
Committee:: CH/210/4 - Risk management and post market surveillance for medical devices
Categories:: Information management | Standardization. General rules

Scope

This document extends the framework of post-market surveillance for machine learning-enabled medical devices (MLMD).

This document describes special requirement, metrics, methods and procedure to implement
post-market surveillance for MLMD.

Purpose

New work item proposal

Comment on proposal

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Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

Would the development of a standard(s) in this area have a particular impact/relevance to SME, consumer, environmental or societal interests? *

Are you aware of any other organizations to which this proposal may be relevant? If so please provide details below. *

Additional comments on the scope or proposal:

Although BSI will not usually enter into correspondence regarding individual comments or suggestions we may wish to contact you to seek further clarification. Please indicate whether this will be acceptable: *

Discard

Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

04/02/2025

Proposal end date:

14/02/2025

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

62/540/NP - Post-market surveillance of machine learning-enabled medical device

Scope

Purpose

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