Understanding MDA, MDN, MDS, and MDT codes in the context of MDR and IVDR

Introduction

Medical devices and in vitro diagnostic (IVD) devices placed on the EU market must undergo rigorous regulatory scrutiny to ensure their safety and performance. To facilitate the designation of Notified Bodies (NBs) and define the scope of conformity assessment, the European Commission has introduced specific codes under Commission Implementing Regulation (EU) 2017/2185. These codes classify medical devices based on their design, intended purpose, special characteristics, and manufacturing processes. The codes play an important role in ensuring that Notified Bodies are competent in evaluating specific types of devices.

The MDA, MDN, MDS, and MDT codes serve distinct purposes in regulatory assessments. Understanding these codes is essential for manufacturers when engaging with a Notified Body for conformity assessment and certification under MDR (EU) 2017/745 and IVDR (EU) 2017/746.

MDA and MDN codes: device design and intended purpose

The MDA (Medical Device Active) and MDN (Medical Device Non-active) codes classify medical devices based on their intended purpose and technological characteristics. These codes define the field of medical application and are primarily used for the allocation of personnel for the assessment of the device’s technical documentation.

• MDA codes: Apply to active medical devices (devices that rely on a source of energy).
• MDN codes: Apply to non-active medical devices (devices that function without an external power source).

Examples of MDA codes (active devices)

• MDA 0101: Active implantable devices for stimulation / inhibition / monitoring
• MDA 0201: Active non-implantable imaging devices using ionizing radiation
• MDA 0315: Software as a medical device (SaMD)

Examples of MDN codes (non-active devices)

• MDN 1102: Non-active osteo- and orthopedic implants
• MDN 1203: Non-active non-implantable guide catheters, balloon catheters, and related tools
• MDN 1210: Non-active non-implantable contraceptive devices (e.g., condoms, diaphragms)

Key takeaways for manufacturers

• Each device is assigned exactly one MDA or MDN code based on its primary intended purpose and technological function.
• If multiple codes apply, the highest-listed code should be chosen to ensure consistency in regulatory assessment.
• Notified Bodies allocate expert assessors based on the MDA/MDN codes assigned to the device.

MDS codes: special characteristics of medical devices

The MDS codes (Medical Device Special) categorize medical devices that have specific properties, such as sterility, measurement function, or software incorporation. These horizontal codes apply across different device types and provide additional classification for regulatory purposes.

Examples of MDS codes

• MDS 1001: Devices incorporating medicinal substances
• MDS 1005: Devices in sterile condition
• MDS 1009: Devices incorporating software/utilizing software/controlled by software
• MDS 1010: Devices with a measuring function

Key takeaways for manufacturers

• A single device may have multiple MDS codes depending on its characteristics.
• These codes help define the qualification of assessors involved in reviewing technical documentation.
• If a device has special regulatory requirements, such as containing nanomaterials or being sterile, an MDS code is assigned in addition to an MDA/MDN code.

MDT codes: manufacturing technologies and processes

The MDT codes (Medical Device Technology) classify devices based on the specific manufacturing processes and technologies used in their production. These codes are critical for site audits and production quality assessments.

Examples of MDT codes

• MDT 2001: Devices manufactured using metal processing (e.g., 3D printing, casting)
• MDT 2005: Devices manufactured using biotechnology
• MDT 2009: Devices manufactured using processing of materials of human, animal, or microbial origin
• MDT 2011: Devices requiring specific packaging and labeling

Key takeaways for manufacturers

• Multiple MDT codes may be assigned based on the key manufacturing processes involved.
• The assignment of MDT codes ensures that Notified Bodies allocate auditors with expertise in specific production technologies.
• MDT codes apply even when production is outsourced, meaning suppliers and subcontractors may also need assessment under these codes.

How these codes are used in regulatory processes

The MDA/MDN, MDS, and MDT codes are applied in various stages of Notified Body assessments, including:

• Device classification: Defines how a medical device is categorized under MDR/IVDR.
• Notified Body designation: Ensures the competence of Notified bodies by limiting their scope to specific device categories.
• Personnel qualification: Guarantees that Notified Body staff members have the necessary expertise to assess the изделия.
• Audit and conformity assessments: Guides the selection of technical documentation reviewers and site auditors.

Assignment of codes during the conformity assessment process

When a manufacturer applies for certification, the Notified Body verifies the device classification and assigns the appropriate codes. These codes are then used to allocate competent experts for review and audits.

Example: how codes are applied

Let’s take an infusion pump as an example. It may have the following classifications:

• MDA 0306: Active non-implantable devices for extracorporeal circulation
• MDS 1009: Devices incorporating software
• MDS 1010: Devices with a measuring function
• MDT 2010: Devices manufactured using electronic components

In this case:

• MDA 0306 defines the core technology and intended purpose of the device.
• MDS codes indicate additional regulatory requirements (software, measuring function).
• MDT codes define the manufacturing technology, ensuring the correct auditor is assigned.

Conclusion

The MDA, MDN, MDS, and MDT codes are essential tools in the regulatory framework of MDR and IVDR. They:

• Define the scope of Notified bodies and ensure they have the necessary expertise.
• Ensure proper classification of medical devices for regulatory approval.
• Guide the allocation of expert assessors for conformity assessments and audits.

For manufacturers, understanding these codes is crucial for a smooth regulatory process. Proper classification helps streamline Notified Body interactions, documentation review, and audit procedures.

By effectively using these codes, manufacturers can ensure compliance with EU medical device regulations, facilitate smoother certification processes, and ultimately bring safe and effective medical device to market.