Manual on Borderline

https://health.ec.europa.eu/document/download/74e9f1ad-0e61-4b5a-8ac4-aace97d81b32_en?filename=md_borderline_manual_12-2022_en.pdf

Commission Guidance on the content and structure of the summary of the clinical investigation report

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023XC0508(01)

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

https://health.ec.europa.eu/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en.pdf