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Commission Implementing Regulation (EU) 2026/2083 Article 6

Commission Implementing Regulation (EU) 2026/2083 Article 6

Changes to the requirements catalogue

Article 6

1.   Upon request by five or more members of the steering group or on its own initiative, the Commission may submit to the steering group a proposal for a major change to the requirements catalogue. The change proposal shall include at least: (a) a description of the changes; (b) a justification for the changes; (c) a timeline for implementation of the changes; (d) a major release to address the proposed changes. 2.   The steering group shall be responsible for approving the changes to the requirements catalogue referred to in Article 4(2), the timeline for the implementation of the changes and the major release. 3.   Once the changes referred to in paragraph 2 are approved, the Commission, national contact points for digital health and authorised participants shall implement them in accordance with the approved implementation timeline and major release. 4.   A minor release shall not be subject to the submission of a change proposal. The Commission may submit a change for a minor release to the steering group. Where such a change is submitted, the steering group shall, upon receipt, be responsible for approving the proposal for a minor release, including its implementation timeline. Once the minor release is approved, the Commission, national contact points for digital health and authorised participants shall implement it in accordance with the approved implementation timeline.

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Other provisions in Commission Implementing Regulation (EU) 2026/2083

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-10-15

CitationArticle 6 of Commission Implementing Regulation (EU) 2026/2083 (LawPlayer, data as of 2026-10-15)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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