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- CHAPTER II
Article number: 9
Relevant actions taken by manufacturers in relation to their product approval process shall be duly documented, kept for audit purposes and made available to the competent authorities upon request.
Metadata
RULEBOOK TOPIC: CHAPTER II - PRODUCT GOVERNANCE REQUIREMENTS FOR MANUFACTURERS
RULEBOOK CATEGORY: Delegated Regulation (EU) 2017/2358 (related to product oversight and governance requirements)
Last update on: 16 Apr 2021