substantial modification
as defined in Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16…, Article 2(2), point (13) (Definitions)
any change to any aspect of the clinical trial which is made after notification of a decision referred to in Articles 8, 14, 19, 20 or 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial
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Also defined in
- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on horizontal cybersecurity requirements for… 52022PC0454, Article 3, point (31)
a change to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential requirements set out in Section 1 of Annex I or results in a modification to the intended use for which the product with digital… - Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL… 52021PC0206, Article 3, point (23)
a change to the AI system following its placing on the market or putting into service which affects the compliance of the AI system with the requirements set out in Title III, Chapter 2 of this Regulation or results in a modification to the intended purpose for which the AI system has been assessed - Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity… 32024R2847, Article 3, point (30)
a change to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I or which results in a modification to the intended purpose for which the… - AI Act 32024R1689, Article 3, point (23)
a change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is… - Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective… 32024L2853, Article 4, point (18)
a modification of a product after it has been placed on the market or put into service: (a) that is considered substantial under relevant Union or national rules on product safety; or (b) where relevant Union or national rules on product safety lay down no threshold on what is to be considered a… - Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing… 32023R1230, Article 3, point (16)
a modification of machinery or a related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen or planned by the manufacturer, and which affects the safety of that machinery or related product, by…