Article 1
Open ↗Implementing Decision (EU) 2019/1396 is amended as follows: (1) Article 1(1) is amended as follows: (a) point (11) is replaced by the following: ‘(11) In vitro diagnostic medical devices (IVD);’; (b) the following point (12) is added: ‘(12) Paediatrics and rare diseases.’; (2) Article 2(6) is replaced by the following: ‘6. Where it is necessary due to the workload of a certain expert panel or the need to provide the required expertise to a certain expert panel, advisors on the central list or in another expert panel may be assigned to that expert panel for a specific role or task and for a limited period of time.’ ; (3) Article 3(1) is replaced by the following: ‘1. An expert panel may, in agreement with the Secretariat referred to in Article 10, establish permanent or ad hoc sub-groups entrusted with specific tasks and composed of a certain number of its members.’ ; (4) Article 8 is amended as follows: (a) the title is replaced by the following: ‘Preparation of opinions, views or advice’; (b) paragraph 1 is replaced by the following: ‘1. For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’ ; (5) Article 9 is amended as follows: (a) in paragraph 1, the first subparagraph is replaced by the following: ‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’; (b) paragraph 3 is replaced by the following: ‘3. The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’ ; (c) paragraph 4 is replaced by the following: ‘4. The common rules of procedure shall be publicly available on a dedicated website.’ ; (6) in Article 10, paragraphs 1 and 2 are replaced by the following: ‘The European Medicines Agency, acting as secretariat for the expert panels in accordance with Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council ( *1 ) , shall also provide the secretariat for the Committee referred to in Article 7 of this Decision (the “Secretariat”). ( *1 ) Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices ( OJ L 20, 31.1.2022, p. 1 , ELI: http://data.europa.eu/eli/reg/2022/123/oj ).’;" (7) in Article 11, paragraph 2 is replaced by the following: ‘2. Travel and, where appropriate, subsistence expenses of advisors in connection with the activities of the expert panels governed by this Decision shall be reimbursed by the Secretariat in accordance with the provisions in force at the European Medicines Agency. Those expenses shall be reimbursed within the limits of the available appropriations allocated to the European Medicines Agency under the annual procedure for the allocation of resources.’ ; (8) Article 12(5) is replaced by the following: ‘5. Where the obligations referred to in paragraphs 1 to 4 are not met, the Commission or the Secretariat may take all appropriate measures.’ ; (9) Article 14 is amended as follows: (a) in introductory part, the second sentence is replaced by the following: ‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’; (b) point (d) is replaced by the following: ‘(d) opinions, views and advice in accordance with Article 8.’; (10) Article 15(3) is replaced by the following: ‘3. Where the obligations referred to in paragraphs 1 and 2 are not met, the Commission or the Secretariat may take all appropriate measures.’ ; (11) the Annex is amended in accordance with the Annex to this Decision.