Article 1, Point (1) · Commission Delegated Regulation (EU) 2025/1421

Contents

(1) in MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED…
(2) in MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS…

(1)in MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING, point 4, the following paragraph is added:‘The thermal cycles and test referred to in points 4.3 and 4.4 shall be carried out in laboratories that are accredited for those activities by a national accreditation body.’;