Recital 7

Commission Delegated Directive (EU) 2022/1632 of 12 May 2022 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of lead in certain magnetic resonance imaging devices (Text with EEA relevance) · European Union

(7) The evaluation of the renewal request, which included a technical and scientific assessment study (3), concluded that old design MRI devices depend on lead-containing MRI components and are highly limited in their compatibility with new lead-free MRI components. That evaluation further concluded that lead-free models of non-integrated MRI coils are already available. However, as concerns MRI devices with integrated coils, the technical development and the approval procedure to develop lead-free solutions require additional time.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-17 · Text as adopted (Official Journal); later amendments are not incorporated in this text.