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Medical Devices – Guidance documents, publications and factsheets: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_guidance_meddevs.pdf (old Directives) https://ec.europa.eu/health/medical-devices-new-regulations/guidance_en https://ec.europa.eu/health/medical-devices-new-regulations/publications_en (new Regulations)

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.