Article 1
Open ↗Part II of Annex IV to Regulation (EU) 2019/1009 is amended as follows: (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.’; (2) in MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS, point 6.3.2, the introductory statement is replaced by the following: ‘For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the notified body shall carry out annual audits. In addition, the notified body shall take and analyse output material samples with the following frequency:’.