(b)
The notified body shall decide on the issuing, restriction, suspension or withdrawal of the validation report on the basis of: validation of the input values, assumptions made and compliance with applicable generic or product category specific rules; validation of the manufacturer’s assessment; validation of the process applied to generate that assessment; validation of the correct usage of software appropriate for the assessment; initial inspection of the manufacturing plant to validate any company-specific data.
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Source: EUR-Lex (Cellar) · retrieved 2026-10-17 · Text as adopted (Official Journal); later amendments are not incorporated in this text.