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White paperMichael Clark
The Declared Change Envelope
The declared change envelope, the description of pre-determined changes in a high-risk system's technical file, is a product decision that in our experience is usually made as a documentation task. Under Article 3(23) of the AI Act, a change is substantial only if it was not foreseen in the initial conformity assessment and affects compliance or the intended purpose, so the envelope gives the provider considerable influence over the first limb, on foresight. We propose five elements written to the FDA change control plan structure; a narrow envelope is dearer for the life of the product, and customers should obtain it before signature.
Key findings
- The change envelope is a product decision, and in our experience it is usually made as a documentation task.
- Size is not the test: an anticipated and documented change is not substantial, while a modest unanticipated change can be if it affects compliance or the intended purpose.
- The same change can be tested under up to four regimes (the AI Act, the medical device rules, the Machinery Regulation and the Product Liability Directive), and the answers can differ.
In the paper
- The test has two limbs, and the provider writes the first
- One change, up to four tests
- What the envelope should contain
- Narrow is cheaper on the day
- For the customer
- Set it at the initial assessment
Michael Clark
Chief Executive Officer, Standard Intelligence
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