Commentaires formels

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.

Formal comments on the draft Commission Implementing Regulation laying down detailed specifications regarding the functional requirements for eFTI platforms in accordance with Regulation (EU) 2020/1056 of the European Parliament and of the Council.

EDPS Formal comments on the draft Implementing and Delegated Regulations laying down detailed rules for the implementation of Council Regulation (EC) No 1224/2009 (‘the Control Regulation’).

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.

EDPS Formal comments on the draft Commission Delegated Decision as regards specifying the conditions for the correspondence between the data present in a record, alert or file of other EU information systems consulted and an ETIAS application file