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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 (Text with EEA relevance) article 30 CELEX: 02022R0123-20250101 Support for the expert panels on medical devices
From 1 March 2022, on behalf of the Commission, the Agency shall provide the secretariat for the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 (the ‘expert panels’) and shall provide the support necessary to ensure that those expert panels can efficiently perform the tasks set out in Article 106(9) and (10) of that Regulation.
The Agency shall: (a) provide administrative and technical support to the expert panels for the provision of scientific opinions, views and advice; (b) facilitate and manage remote and physical meetings of the expert panels; (c) ensure that the work of the expert panels is carried out in an independent manner in accordance with Article 106(3), second subparagraph, and Article 107 of Regulation (EU) 2017/745 and with the systems and procedures established by the Commission pursuant to that Regulation to actively manage and prevent potential conflicts of interest in accordance with Article 106(3), third subparagraph, of that Regulation; |
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 (Text with EEA relevance) article 30 CELEX: 02022R0123-20250101 (d) maintain and regularly update a webpage for the expert panels and make all necessary information not already publicly available in Eudamed publicly available on that webpage in order to ensure the transparency of the activities of the expert panels, including providing the justifications of notified bodies where those bodies did not follow the advice of the expert panels provided pursuant to Article 106(9) of Regulation (EU) 2017/745; (e) publish the scientific opinions, views and advice of the expert panels while ensuring confidentiality in accordance with Article 106(12), second subparagraph, and Article 109 of Regulation (EU) 2017/745; (f) levy fees in accordance with Article 106(14) of Regulation (EU) 2017/745 and ensure that remuneration and expenses are provided to experts in accordance with implementing acts adopted by the Commission pursuant to Article 106(1) of Regulation (EU) 2017/745; (g) monitor compliance with the expert panels’ common rules of procedure and available guidelines and methodologies relevant to the functioning of the expert panels; |
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 (Text with EEA relevance) article 30 CELEX: 02022R0123-20250101 (h) provide annual reports to the Commission and the MDCG on the work of the expert panels, including information on the number of opinions delivered and the views and advice provided by the expert panels. |