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References / Sources
i MDCG 2021-5 Rev. 1, Guidance on standardisation for medical devices. Revision 1—July 2024, available at https://health.ec.europa.eu/document/ download/59ac4cb0-f187-4ca2-814d-82c42cde5408_en
[Accesses 25 Nov 2025]
ii CEN and CENELEC available at https://www.cencenelec.eu/european- standardization/cen-and-cenelec/
[Accesses 25 Nov 2025]
iii
International Organisation for Standardization (ISO) available at https://www.iso.org/about
[Accessed 25 Nov 2025]
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