Manual on borderline and classification under Regulations (EU) — Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Background note on the use of the Manual on borderline and classification for medical devices under the Directives. — (April 2026)

Background note — Background note — Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Background note on the use of the Manual on borderline and classification for medical devices under the Directives. — (April 2026)

MDCG 2021-24 rev.1 — Guidance on classification of medical devices — (April 2026)

MDCG 2025-6 — FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) — (June 2025)

MDCG 2025-4 — Guidance on the safe making available of medical device software (MDSW) apps on online platforms — (June 2025)

MDCG 2019-11 rev.1 — Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 — (June 2025)

MDCG 2020-16 rev.4 — Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 — (March 2025)

MDCG 2024-11 — Guidance on qualification of in vitro diagnostic medical devices — (October 2024)

MDCG 2022-5 rev.1 — Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices — (October 2024)

MDCG 2023-5 — Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies — (December 2023)