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(41) In addition to their role in clinical evaluation assessments and performance evaluations regarding certain high risk medical devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746, respectively, as well as in providing opinions in response to consultation by manufacturers and notified bodies, the expert panels are to provide scientific, technical, and clinical assistance to the Member States, the Commission and the MDCG. In particular, the expert panels are to contribute to the development of guidance on a number of points, including clinical and performance aspects of specific medical devices, categories, or groups of medical devices or specific hazards related to a category or group of medical devices, develop clinical evaluation and performance evaluation guidance in line with the state of the art, and contribute to the identification of concerns and emerging issues on safety and performance. In that context, the expert panels could play a relevant role in preparedness for and the management of public health emergencies relating to medical devices, particularly those of high risk including those medical devices which have the potential to address public health emergencies, without prejudice to tasks and obligations under Regulations (EU) 2017/745 and (EU) 2017/746.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.