EDPS – Formal comments on the draft Implementing Regulation laying down procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments – June 2025

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EDPS – Formal comments on the draft Commission Delegated Regulation with regard to regulatory technical standards specifying the conditions for the registration of external reviewers and the criteria for assessing the sound and prudent management of external reviewers, the appropriateness of the knowledge, experience and training of the external reviewers’ employees and the conditions under which external reviewers outsource their assessment activities – July 2025

2025_07_07_formal_comments_registration_external_reviewers_criteria_assesing_management_external_reviewers_assessment_knowledge_experience_training_external_reviers_employees_en