MDCG 2026 Updates: Classification Guidance, EMDN Codes, and Borderline Manual Changes Explained

Why the April 2026 MDCG Updates Matter

In April 2026, the European Commission's Medical Device Coordination Group (MDCG) released a package of updated guidance documents that directly affect how manufacturers classify devices, assign nomenclature codes, and determine regulatory boundaries for products in the EU market. These are not minor housekeeping updates — they change how devices fit into the MDR and IVDR classification framework, how they are identified in EUDAMED, and how borderline products are treated.

Every manufacturer that sells medical devices or IVDs in the EU needs to understand these changes, because they affect:

• Device classification — which risk class your device falls into, which conformity assessment route applies, and how much regulatory burden you face
• EUDAMED registration — which EMDN code you must assign to your device in the UDI/Device Registration module, which becomes mandatory on May 28, 2026
• Technical documentation — the classification rationale and nomenclature codes that appear in your technical file
• Borderline determinations — whether your product is a medical device at all, and if so, under which regulation it falls

This guide covers four key updates released in April 2026:

1. MDCG 2021-24 Rev.1 — Updated classification guidance for medical devices
2. MDCG 2026-1, 2026-2, 2026-3 — EMDN annual revision documents
3. MDCG 2021-12 Rev.2 — Updated EMDN FAQ
4. Borderline and Classification Manual Version 5 — New borderline cases and classification examples

Additionally, the MDCG released updated guidance on supply disruption obligations under Article 10a (Q&A Rev.2 and a decision tree), which requires manufacturers to inform Competent Authorities of anticipated supply interruptions or discontinuations. While not directly part of the classification/EMDN update package, this guidance was published alongside it in April 2026 and is relevant for manufacturers managing transition-period compliance.

MDCG 2021-24 Rev.1: Updated Classification Guidance

What Changed

MDCG 2021-24, originally published in October 2021, provides guidance on the classification of medical devices under MDR Annex VIII. Revision 1, released in April 2026, is the first update to this document. While the MDR classification rules themselves have not changed, the guidance has been strengthened in several areas:

Improved alignment with MDR terminology. The revised guidance uses more precise language that mirrors the regulation's own terminology, reducing ambiguity in how rules should be applied. This is particularly important for rules involving "invasive," "surgically invasive," "implantable," and "active" devices.

Clarifications on intended purpose. The guidance provides additional direction on how a device's intended purpose affects its classification. This includes situations where a device has multiple intended purposes that could trigger different classification rules.

Additional real-world examples. New examples have been added for complex devices where classification is not straightforward, including:

• Devices with both diagnostic and therapeutic functions
• Software-based devices that process patient data to provide clinical information
• Combination products where the device component and the drug/biologic component interact
• Devices that can be used in both professional and home-care settings

Expanded Software as a Medical Device (SaMD) guidance. The revised classification guidance includes widened explanations on how SaMD products should be classified under MDR Annex VIII, reflecting the growing number of AI-enabled and cloud-based medical devices entering the EU market. This is particularly relevant given the overlap between MDR classification requirements and the EU AI Act's high-risk AI system requirements.

Practical Impact

The revised guidance does not reclassify devices by itself. However, it may change how you justify your existing classification. If your classification rationale was based on the original 2021 guidance, review it against the revised version. Key areas to check:

• Intended purpose wording. Does your stated intended purpose align with the clarified definitions?
• Multiple function devices. If your device serves more than one purpose, have you applied the classification rule resulting in the higher classification?
• Software classification. Does your software meet the definition of a medical device, and if so, which rule applies?

EMDN v3/2026: New Nomenclature Code Updates

What Is EMDN and Why It Matters

The European Medical Device Nomenclature (EMDN) is the coding system that manufacturers must use when registering devices in EUDAMED. Under MDR Article 26 and IVDR Article 23, the EMDN is linked to each Unique Device Identifier — Device Identifier (UDI-DI) and is used for:

• Device registration in EUDAMED
• Technical documentation identification
• Notified Body sampling of technical documentation
• Market surveillance and post-market monitoring activities
• Facilitating communication between Competent Authorities

If you register a device in EUDAMED, you must assign it an EMDN code. Getting this wrong can delay registration, trigger Notified Body queries, or create compliance issues during surveillance audits.

Three New EMDN Documents

In April 2026, the MDCG released three documents that govern the 2025–2026 annual revision of EMDN codes:

MDCG 2026-1: Summary of EMDN 2025 Submissions and Annual Revision Outcomes This document summarizes all EMDN update requests submitted during the 2025 consultation period and the decisions made by the MDCG Nomenclature Working Group. It categorizes each request as:

• Accepted
• Partially accepted
• Not retained, with the underlying rationale

This transparency helps manufacturers understand why certain code requests were approved or rejected, and informs future submissions.

MDCG 2026-2: 2025–2026 Annual Revision Change Log A detailed record of all EMDN changes resulting from the annual revision process. This includes:

• New codes created to reflect technological advances
• Existing codes modified to clarify scope
• Codes split into more specific sub-categories
• Codes obsoleted or merged with others
• Scope reductions where a code no longer covers certain device types

MDCG 2026-3: 2026 EMDN Version History A complete version history that links current EMDN v.2026 codes to their previous versions. This allows manufacturers to trace how codes have evolved and determine whether their previously assigned codes are still valid.

EMDN Version 3 (v3) Deployment

EMDN v3 was deployed in EUDAMED with the Production v2.22.0 release at the end of January 2026. Key changes include:

• Automated email notifications. EUDAMED now sends an automated email to users if their assigned EMDN code has been discarded, split, or scope-reduced. This is a significant improvement from 2025, when no notification mechanism existed. However, the system does not send emails if the EMDN code was scope-extended or corrected, as no action is generally needed from the manufacturer in those cases.
• New code extensions. The code extension "99 – Others" may now be used as a generic terminal-level code when no more specific terminal code is available. The extension "90 – Various" is used for non-terminal groupings. Understanding the distinction between these two extensions is essential for accurate code assignment.
• Category X for Annex XVI products. Additional guidance is provided for products without a medical purpose listed in MDR Annex XVI (e.g., cosmetic contact lenses, non-corrective colored contact lenses, equipment for brain stimulation).

Practical Steps for Manufacturers

1. Review your EMDN code assignments. Compare your current codes against the MDCG 2026-3 version history to determine if any have changed.
2. Check for automated notifications. If you received an email from EUDAMED about a code change, take action: update your technical documentation, update your EUDAMED registration, and notify your Notified Body if the code appears on your certificate.
3. Request new codes proactively. If your device does not fit any existing EMDN code, you can request a new one through the EU Login-based EMDN request platform. The process involves submission, review by the EMDN Technical Team, evaluation by the MDCG Nomenclature Working Group, and final endorsement by the MDCG.
4. Audit your "99 – Others" codes. If you assigned a generic "99" code as a placeholder, check whether a more specific code has been created in the 2026 revision. EUDAMED accuracy is increasingly being scrutinized during Notified Body audits.

MDCG 2021-12 Rev.2: Updated EMDN FAQ

What's New

The revised FAQ adds four new questions to the existing guidance on EMDN usage:

1. Distinction between code extensions "90" and "99." Code extension "90 – Various" is used for non-terminal groupings, while "99 – Others" is a terminal-level code used when no specific terminal code exists. Using them interchangeably is incorrect and can cause registration errors.

2. Devices with multiple intended uses. When a device has multiple intended uses that fall under different EMDN categories, the manufacturer should assign the code that best represents the primary intended use. If no single code captures all intended uses, multiple codes may be assigned.

3. Proper consultation of the EMDN. The FAQ clarifies the recommended process for identifying the correct EMDN code: start from the top-level category, navigate through sub-categories, and select the most specific terminal-level code that matches the device.

4. Category X for Annex XVI products. Products without a medical purpose listed in MDR Annex XVI have their own EMDN category (Category X). Manufacturers of these products should not attempt to classify them under medical device categories.

Why This Matters

With EUDAMED registration becoming mandatory on May 28, 2026 for all new MDR/IVDR devices (and November 27, 2026 for legacy devices), accurate EMDN code assignment is no longer optional. Incorrect codes will cause registration errors, delay market access, and may trigger additional scrutiny from Competent Authorities and Notified Bodies.

Borderline and Classification Manual Version 5

What Is the Borderline Manual

The Manual on Borderline and Classification is a reference document produced by the MDCG that provides concrete examples of how specific products have been classified or determined to fall outside the scope of the MDR or IVDR. It is not legally binding, but it reflects the consensus view of EU Competent Authorities and is widely used as a reference by manufacturers, Notified Bodies, and regulators.

Version 5, released in April 2026, adds new borderline cases and classification examples covering emerging technologies and product categories where regulatory boundaries are unclear.

Key Areas Covered in Version 5

• Digital health products. New examples address how certain software, apps, and AI-based tools are classified — or excluded from classification — under the MDR and IVDR. This is particularly relevant given the ECRI's April 2026 recommendation to Congress that many general wellness devices lack adequate oversight.
• AI-enabled medical devices. Cases addressing the intersection of MDR classification rules and the EU AI Act requirements for high-risk AI systems.
• Combination products. Updated guidance on products at the boundary between medical devices, medicinal products, and cosmetics.
• Products without medical purpose. Additional examples for MDR Annex XVI products, including aesthetic devices and wellness products that do not make medical claims.
• IVD classification edge cases. New examples for products at the boundary between IVDs and general laboratory equipment, and between self-testing devices and professional-use devices.

How to Use the Borderline Manual

The manual should be used as a reference tool, not as a substitute for your own classification rationale. When classifying a device:

1. Start with the classification rules in MDR Annex VIII or IVDR Annex VIII.
2. Consult MDCG 2021-24 Rev.1 for interpretive guidance.
3. Check the Borderline Manual for analogous cases.
4. If your device resembles a case in the manual, document the comparison in your classification rationale.
5. If no analogous case exists, consider requesting a classification opinion from a Competent Authority or using the structured dialogue mechanism with your Notified Body.

EUDAMED Registration: The May 28, 2026 Connection

These MDCG updates land just weeks before EUDAMED registration becomes mandatory. On May 28, 2026:

• All new MDR and IVDR devices must be registered in EUDAMED before being placed on the EU market
• Notified Bodies begin uploading new certificates
• The Actor, UDI/Device Registration, Notified Bodies/Certificates, and Market Surveillance modules become mandatory

For manufacturers, this means:

1. Verify your EMDN codes now. Incorrect codes will cause EUDAMED registration to fail or be flagged for correction.
2. Update classification rationales. If the revised MDCG 2021-24 guidance affects your classification, update your technical documentation before registration.
3. Check for legacy device codes. If you have legacy devices that must be registered by November 27, 2026, verify their EMDN codes against the v3/2026 nomenclature.

Frequently Asked Questions

Do the MDCG 2026 updates change my device's classification? The guidance itself does not reclassify devices. However, the clarifications in MDCG 2021-24 Rev.1 and the new examples in the Borderline Manual may change how you interpret the classification rules. If your classification rationale was borderline before, these updates may push it in a different direction.

What if my EMDN code has changed? Check MDCG 2026-3 for the version history. If your code was split, discarded, or scope-reduced, you should have received an automated email from EUDAMED. Update your technical documentation and EUDAMED registration accordingly.

Can I request a new EMDN code? Yes. Use the EU Login-based EMDN request platform. You will need to provide the proposed code description, rationale, and supporting information about the device type. The request is evaluated by the EMDN Technical Team and MDCG Nomenclature Working Group.

Are MDCG guidance documents legally binding? No. MDCG guidance documents reflect the consensus view of EU Competent Authorities but are not legally binding in the same way as regulations or directives. However, Notified Bodies and Competent Authorities use them as the primary reference for interpreting MDR and IVDR requirements, so deviating from them without strong justification is risky.

Do I need to update my technical documentation immediately? You should review your classification rationale and EMDN codes against the updated guidance. If the updates reveal that your classification or code assignment needs correction, update your technical documentation before your next EUDAMED registration or Notified Body interaction.

Key Takeaways

1. MDCG 2021-24 Rev.1 provides the first update to classification guidance since 2021, with clarified terminology and additional real-world examples.
2. EMDN v3/2026 introduces new, modified, and obsoleted codes. Automated EUDAMED notifications now alert manufacturers when their codes change.
3. MDCG 2026-1/2/3 provide full transparency on the annual EMDN revision — what changed, why, and how it maps to previous versions.
4. MDCG 2021-12 Rev.2 adds four new FAQ items clarifying code extension usage, multiple intended use assignments, and Annex XVI product categorization.
5. Borderline Manual v5 adds new cases for digital health, AI devices, combination products, and IVD edge cases.
6. EUDAMED mandatory registration on May 28, 2026 makes accurate EMDN code assignment an urgent compliance requirement.
7. Manufacturers should audit their EMDN codes and classification rationales against these updates before registering devices in EUDAMED.