We issue formal comments as part of our role as advisor on all matters relating to the procesing of personal data.
Similar to our Opinions, our Formal Comments are issued in response to a request from the European Commission under Article 42(1) of Regulation (EU) 2018/1725 and address the data protection implications of a legislative proposal or a draft implementing or delegated act. Our Formal comments are usually shorter and more technical, or only address certain aspects of a proposal.
EDPS Formal comments on the draft Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2023/1805, as regards access rights and the functional and technical specifications of the FuelEU database.
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.