EU-AIA-63-03
Requirement
63 — Derogations for specific operators
Continued Compliance with Other Requirements Despite Simplified QMS
Description
Operators (including SMEs benefiting from simplified quality management system compliance) must still fulfill all other requirements and obligations under the Regulation, including those set out in Articles 9 (risk management), 10 (data governance), 11 (technical documentation), 12 (record-keeping), 13 (transparency), 14 (human oversight), 15 (accuracy, robustness, cybersecurity), 72 (post-market monitoring), and 73 (reporting of serious incidents).
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