Borderline and Classification Archive

Helsinki Procedure – Helsinki Procedure for borderline and classification under MDR & IVDR

Helsinki Procedure Rev.0 Helsinki Procedure for borderline and classification under MDR & IVDR Disclaimer: This document is an interactive version of the original MDCG document.

Januar 20, 2025

Manual on Borderline Background note – Background note on the use of the Manual on borderline and classification for medical devices under the Directives.

Manual on Borderline Background note Rev.0 Background note on the use of the Manual on borderline and classification for medical devices under the Directives Disclaimer:

Januar 20, 2025

Manual on Borderline rev.3 – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746

Manual on Borderline Rev.3 Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 Disclaimer: This document is an interactive version of the original

Januar 20, 2025

MDCG 2024-13 – Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices

MDCG 2024-13 Rev.0 Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices Disclaimer: This document is an interactive version of the

Januar 20, 2025

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

MDCG 2022-5 Rev.1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices Disclaimer: This document is an interactive

Januar 20, 2025

MDCG 2021-24 – Guidance on classification of medical devices

MDCG 2021-24 Guidance on classification of medical devices Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.

Januar 20, 2025

MDCG HELPDESK

MDCG Helpdesk – Structured. Searchable. Up to Date.

Helsinki Procedure – Helsinki Procedure for borderline and classification under MDR & IVDR

Manual on Borderline Background note – Background note on the use of the Manual on borderline and classification for medical devices under the Directives.

Manual on Borderline rev.3 – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746

MDCG 2024-13 – Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices

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

MDCG 2021-24 – Guidance on classification of medical devices