EC-Medical Device Coordination Group: Guidance on Classification of Medical Devices, Nomenclature (EMDN), and Supply Continuity Obligations

The European Union continues to strengthen its medical device regulatory framework through updated guidance on device classification, nomenclature (EMDN), and supply chain transparency. These updates aim to improve regulatory clarity, traceability, and patient safety, particularly under the MDR and IVDR frameworks.

Key developments include the Update – MDCG 2021-24 Rev.1: Guidance on classification of medical devices (April 2026), alongside supporting guidance documents on EMDN FAQs and supply interruption obligations. These collectively provide a comprehensive regulatory approach across classification, identification, and availability of medical devices in the EU.

Guidance 1: Classification of Medical Devices – MDCG 2021-24 Rev.1

This guidance provides a detailed framework for the classification of medical devices under Regulation (EU) 2017/745 (MDR). The April 2026 revision introduces updates to classification rules, terminology, and practical interpretation to ensure consistent application across the EU.

Background

Medical device classification in the EU follows a risk-based approach, considering factors such as duration of use, invasiveness, and potential risks to patients.

Devices are classified into four main classes:

• Class I (low risk)

• Class IIa and IIb (medium risk)

• Class III (high risk)

This classification directly impacts regulatory requirements, including conformity assessment, clinical evaluation, and post-market surveillance.

Scope

The guidance applies to all medical devices regulated under MDR, including:

• Standard medical devices

• Active devices and software

• Implantable and invasive devices

• Systems and procedure packs

It also provides interpretation for borderline cases and complex classification scenarios.

Core Principles of Classification

Classification is determined based on the intended purpose defined by the manufacturer, not on similar products or actual use in practice.

The strictest applicable rule always applies when multiple classification rules are relevant.

The classification process must consider all device characteristics, including biological effects, energy use, and anatomical interaction.

Guidance 2: European Medical Device Nomenclature (EMDN) – FAQs

The EMDN FAQs explain how medical devices are categorised and coded within the EU regulatory system, supporting EUDAMED and UDI implementation. The EMDN is a standardised nomenclature system developed to support MDR and IVDR requirements, particularly for device registration, traceability, and post-market surveillance. It is based on the Italian CND system and has been adapted for EU-wide use.

Structure of EMDN

The diagram on page 4 shows that EMDN follows a seven-level hierarchical structure, consisting of:

• Categories (top level)

• Groups

• Types (multiple levels of detail)

Each code is alphanumeric and linked to a precise device description, enabling consistent classification and identification.

Assignment of Codes

Manufacturers must assign the most specific (lowest-level) code available to each device in EUDAMED.

Only one code should generally be used, unless the device has multiple intended purposes.

If no suitable code exists, manufacturers may use the ‘99 – Other’ category and propose new codes for future updates.

Guidance 3: Supply Interruptions and Discontinuations – Article 10a MDR/IVDR

The Supply Interruptions and Discontinuations FAQ provides guidance on manufacturer obligations to notify authorities and stakeholders about supply disruptions. This guidance implements Regulation (EU) 2024/1860, which introduced mandatory notification requirements to prevent risks related to device shortages and ensure continuity of care.

Scope

The requirements apply to manufacturers of medical devices and in vitro diagnostic devices where supply interruptions could lead to serious harm to patients or public health.

Information Obligations

Manufacturers must inform:

• Competent authorities

• Economic operators (importers, distributors)

• Health institutions and healthcare professionals

Notifications must generally be provided at least six months in advance of a planned interruption or discontinuation.

Definition of Interruption and Discontinuation

An interruption refers to a temporary inability to supply devices, typically exceeding 60 days.

A discontinuation refers to a permanent cessation of the supply of a device.

Exceptional Circumstances

In cases where advance notice is not possible (e.g., sudden supply chain issues or natural disasters), manufacturers must notify authorities without undue delay.

Supply Chain Responsibilities

Once notified, economic operators must cascade the information downstream to ensure that all affected stakeholders are informed, including healthcare providers.

These three guidance documents collectively strengthen the EU medical device regulatory framework by integrating:

• Risk-based classification systems ensure appropriate regulatory control

• Standardised nomenclature (EMDN) for consistent identification and traceability

• Supply chain transparency obligations to safeguard the availability of critical devices

Together, they support a more resilient, transparent, and patient-focused regulatory ecosystem, aligning with the EU’s broader goals of improving healthcare safety and regulatory efficiency.

References

For complete official guidance, refer to:

• MDCG 2021-24 Rev.1: Guidance on classification of medical devices – April 2026

• EMDN FAQs (MDCG 2021-12 Rev.2) – April 2026

• Supply interruptions and discontinuations FAQ – MDR/IVDR Article 10a