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Is packaging for medicines or medical devices exempt from the declaration of conformity?

421 questions from 58 articles available in English.

No. Specific exemptions apply to this packaging: the recyclability requirement applies neither to the immediate packaging of medicinal products nor to contact-sensitive packaging for medical devices and in vitro diagnostic devices (Article 6, paragraph 11, points a, b and c), and the same plastic packaging is exempt from minimum recycled content (Article 7, paragraph 4). Compliance with the minimisation requirement (Article 10) is required only from 1 January 2030, for all packaging. However, the EU declaration of conformity and technical documentation have been required since 12 August 2026, covering the heavy metal limit in Article 5, paragraph 4, and then labelling when it becomes applicable. An exemption must be documented; it does not remove the documentation requirement.

Read the source article: PPWR EU declaration of conformity: required contents