Finding the Requirements for a Product

A useful requirements review begins with a defined object. Record the model, configuration, materials, functions, intended users, intended use and distribution arrangements. Include accessories, software and consumables where they affect the product. Distinguish what the product does from the claims used to sell it. A different claim or user group can change the applicable regulatory pathway even when the physical article is unchanged.

Review the characteristics that can bring the product within a federal framework: food contact, medical purpose, radio transmission, child use, energy-consuming functions, chemical composition or transport classification. A product can be subject to several agencies at once. Record the reason each framework is considered and the evidence needed to resolve uncertain classifications. Do not treat absence from one agency’s catalogue as evidence that no other requirements apply.

For each candidate requirement, identify whether it is a regulation, an incorporated standard, agency guidance, a voluntary program or a contractual condition. These distinctions affect the decision. A publisher’s standard can be voluntary in general and binding in a specified adopted context. Conversely, an agency’s guidance can be technically useful without establishing an independent legal obligation. Preserve the controlling provision and its conditions.

Use one row for each independently reviewable requirement. Record the citation, scope, edition, responsible role, acceptance criterion and supporting evidence. Include a reasoned exclusion where a plausible requirement does not apply. “Not applicable” without an explanation gives the next reviewer no basis for understanding the conclusion. A requirement register should expose unresolved questions rather than hide them in a completed checklist.

Illustrative example: a connected household appliance may require separate consideration of energy performance, radio authorization, labeling, electrical installation conditions and lithium battery transport. A radio module authorization does not answer the energy question. A transport test summary does not establish charging safety. This example describes a method of separating questions; it is not a determination for any specific product.

Assign the review to people with the relevant technical and regulatory competence. Record the decision, date, evidence and open conditions. Establish review triggers for design, supplier, software, intended use, claim and regulatory changes. Use the Product Applicability Record and the industry index to organize the work. Keep the controlling source with the organization’s decision record.