On May 28, 2026, the European Union's European Medical Device Database (EUDAMED) reached its most critical implementation milestone: four of its six core modules became mandatory for medical device and in vitro diagnostic (IVD) manufacturers, importers, authorised representatives, and notified bodies.
This mandatory transition was enabled by Regulation (EU) 2024/1860 and formally triggered by Commission Implementing Decision (EU) 2025/2371 (published November 27, 2025), which officially declared the first four EUDAMED modules fully functional. As of May 28, 2026, mandatory registration applies to all new medical devices placed on the EU market under the Medical Devices Regulation (MDR, Regulation (EU) 2017/745) and In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746).
While compliance advisories have focused heavily on legal deadlines, few analyses have examined the empirical contents of EUDAMED itself. Analysis of European Commission database mirrors provides a comprehensive, data-anchored quantitative overview of the database: 2,926,029 registered device records, 48,506 unique registered economic actors, and 3,937 active certificates.
This guide provides medtech regulatory directors, legal counsel, quality managers, and supply chain leads with an empirical breakdown of EUDAMED's architecture, geographic actor distribution, device risk-class mix, notified body bottlenecks, machine-to-machine integration requirements, and upcoming compliance milestones.
Executive Summary & Regulatory Timeline
| Regulatory & Legislative Milestone | Official Target Date | Applicable Scope & Legal Requirement |
|---|---|---|
| Commission Functionality Notice | November 27, 2025 | Published OJEU (Decision 2025/2371); initiated 6-month transition |
| Mandatory Module Go-Live | May 28, 2026 | Mandatory use of 4 modules: Actor, UDI/Device, Certificates, Market Surveillance |
| Legacy Device Registration Cutoff | November 27, 2026 | Mandatory registration of all legacy devices (MDD/AIMDD/IVDD) remaining in distribution |
| Certificate Upload Cutoff | May 28, 2027 | Mandatory upload by Notified Bodies of certificates issued prior to May 28, 2026 |
| Vigilance & Clinical Modules | Expected 2027 | Final 2 modules to become mandatory following independent audit & OJEU publication |
What modules are mandatory as of May 28, 2026?
Under Regulation (EU) 2024/1860, the European Parliament and Council amended the MDR/IVDR implementation rules, decoupling the mandatory rollout of individual EUDAMED modules from the completion of the entire platform. This allowed functional modules to go live progressively rather than stalling registration until the complex Vigilance and Clinical modules were ready.
EUDAMED Module Architecture & Operational Status
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[Mandatory as of May 28, 2026] [Voluntary / Audit Phase]
------------------------------ -------------------------
1. Actor Registration (SRN) 5. Vigilance & Post-Market Surveillance
2. UDI & Device Registration 6. Clinical Investigations & Performance Studies
3. Notified Bodies & Certificates
4. Market Surveillance (NCAR)
Deep Dive into Mandatory Modules
- Actor Registration Module: Mandatory for all manufacturers (EU and non-EU), authorised representatives (ARs), importers, and system/procedure pack producers (SPPPs) to obtain a Single Registration Number (SRN) prior to placing devices on the Union market.
- UDI & Device Registration Module: Mandatory for registering Basic UDI-DI and UDI-DI attributes for all new MDR/IVDR devices prior to placement on the market.
- Notified Bodies and Certificates Module: Mandatory for notified bodies to register EU technical documentation assessment certificates, quality management system certificates, and conformity decisions.
- Market Surveillance Module: Mandatory for national competent authorities to coordinate market surveillance activities, share safety alerts, and manage National Competent Authority Reports (NCAR).
EUDAMED Database Scale: 2.93 Million Device Records
As of mid-2026, the public EUDAMED registry contains 2,926,029 device records, representing one of the largest structured medical product registries globally.
EUDAMED Device Classification Breakdown (2.93M Records)
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Class I (Low Risk) [#################################] 1,447,143 (51.9%)
Class IIa (Medium Risk) [##################] 789,875 (28.3%)
Class IIb (Medium-High Risk) [##########] 430,131 (15.4%)
Class III (High Risk) [###] 119,642 (4.3%)
IVD Devices [###] 138,847 (4.7%)
Risk-Class Distribution Analysis
| Device Classification | Registered Record Count | Percentage of Medical Devices | Regulatory & Clinical Context |
|---|---|---|---|
| Class I (General / Low Risk) | 1,447,143 | 51.9% | Non-sterile, non-measuring instruments, reusable surgical tools, hospital beds, manual wheelchairs |
| Class IIa (Low-Medium Risk) | 789,875 | 28.3% | Dental materials, hearing aids, diagnostic ultrasound, short-term invasive surgical devices |
| Class IIb (Medium-High Risk) | 430,131 | 15.4% | Surgical lasers, infusion pumps, hemodialysis machines, long-term surgical implants |
| Class III (High Risk) | 119,642 | 4.3% | Coronary stents, heart valves, joint replacements, active implantable devices |
| In Vitro Diagnostics (IVD) | 138,847 | 4.7% of total | Reagents, calibrators, analyzers, and molecular testing kits under IVDR (Class A/B/C plus List A/B and self-test) |
Granular Device Data Insights
- On-the-Market Status: 2,868,528 records (98.0%) represent active devices currently on the EU market, with the remainder representing historic registrations or withdrawn models.
- Model Count vs. Revenue: In EUDAMED, device counts reflect distinct UDI-DI / model registrations rather than sales volume. Manufacturers of orthopedic implants, dental components, and corrective eyewear register numerous size and dimension variations, driving up Class I and Class IIa record totals.
- Comparison with US FDA GUDID: The high volume of registered Class I items reflects EU UDI rules requiring distinct UDI-DI assignments for individual packaging configurations.
For comparison with US medical device classification and UDI dynamics, review our analysis of the orthopedic UDI landscape and FDA-registered device establishments by country.
Global Economic Actor Distribution: 48,506 Registered SRNs
Registration in the EUDAMED Actor Module is the prerequisite for all economic operations under MDR/IVDR. Across all global jurisdictions, EUDAMED registers 48,506 unique economic actors holding active Single Registration Numbers (SRNs).
EUDAMED Economic Actor Role Distribution
=========================================
Manufacturers (MF) [#################################] 31,751 (65.5%)
Importers (IMP) [############] 12,186 (25.1%)
Authorised Representatives (AR) [###] 2,921 (6.0%)
System/Procedure Pack Producers [##] 1,648 (3.4%)
| Actor Role | Registered SRN Count | Role Share | Operational Responsibility under MDR/IVDR |
|---|---|---|---|
| Manufacturer (MF) | 31,751 | 65.5% | Legal entity responsible for design, manufacture, packaging, and label compliance |
| Importer (IMP) | 12,186 | 25.1% | EU-established entity placing non-EU devices onto the Union market |
| Authorised Representative (AR) | 2,921 | 6.0% | Designated EU entity representing non-EU manufacturers before competent authorities |
| System & Procedure Pack Producer | 1,648 | 3.4% | Entities combining CE-marked devices into clinical surgical or diagnostic packs |
Global Geographic Actor Leaderboard
Analysis of registered actor addresses reveals that China holds the largest number of registered economic-actor SRNs in EUDAMED, outpacing every EU member state and the United States — a finding consistent across both total-actor and manufacturer-only counts.
Top 10 Registered Actor Countries in EUDAMED (SRN Count)
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1. China (CN) [###################################] 7,368 SRNs
2. Germany (DE) [################################] 6,819 SRNs
3. Italy (IT) [####################] 4,215 SRNs
4. France (FR) [##############] 3,106 SRNs
5. United States (US)[############] 2,610 SRNs
6. Netherlands (NL) [###########] 2,415 SRNs
7. Spain (ES) [##########] 2,129 SRNs
8. Türkiye (TR) [########] 1,789 SRNs
9. Poland (PL) [#######] 1,566 SRNs
10. United Kingdom [#####] 1,105 SRNs
| Rank | Country | SRN Count | Share of Global Actors | Primary MedTech Industry Hubs |
|---|---|---|---|---|
| 1 | China (CN) | 7,368 | 15.2% | PPE, single-use disposables, surgical instruments, diagnostic consumables |
| 2 | Germany (DE) | 6,819 | 14.1% | Precision surgical tools, diagnostic imaging, orthopedic implants, IVDs |
| 3 | Italy (IT) | 4,215 | 8.7% | Biomedical engineering, dental equipment, renal care disposables |
| 4 | France (FR) | 3,106 | 6.4% | Orthopedic implants, surgical robotics, active implantables |
| 5 | United States (US) | 2,610 | 5.4% | Cardiovascular devices, orthopedic implants, molecular IVD platforms |
| 6 | Netherlands (NL) | 2,415 | 5.0% | Medical imaging, patient monitoring, IVD and life-sciences distribution |
| 7 | Spain (ES) | 2,129 | 4.4% | Hospital equipment, single-use medical plastics, dental products |
| 8 | Türkiye (TR) | 1,789 | 3.7% | Medical disposables, contract device manufacturing, sterilization supplies |
| 9 | Poland (PL) | 1,566 | 3.2% | Contract manufacturing, medical plastics, wound care |
| 10 | United Kingdom (GB) | 1,105 | 2.3% | Wound management, orthopedics, digital health software |
This finding parallels trends observed in US FDA registration databases. For details on how drug and device registrations compare across EU and US regulators, see our guide on what the EU approves (EMA medicines analysis) and EU CTIS clinical trials by the numbers.
Certificate Volume & The Notified Body Bottleneck
The Notified Bodies and Certificates module records 3,937 certificates registered by designated notified bodies.
EUDAMED Certificate Status Breakdown (3,937 Total)
===================================================
Issued / Active Certificates [#################################] 2,521 (64.0%)
Supplemented / Modified [##########] 791 (20.1%)
Withdrawn [##] 74 (1.9%)
Cancelled [#] 56 (1.4%)
Other Administrative States [#####] 495 (12.6%)
The Notified Body Capacity Bottleneck
A central challenge facing medtech regulatory leads in 2026 is the structural imbalance between device volume and notified body capacity.
- Designated MDR Notified Bodies: Approximately 49 to 55 notified bodies are designated under Regulation (EU) 2017/745 in the European Commission's NANDO database.
- Workload Ratio: Across 31,751 registered manufacturers and 2.93 million device records, each designated notified body must oversee an average of over 550 manufacturing entities and thousands of technical documentation files.
- Transition Extension Mechanics: Under Regulation (EU) 2023/607, legacy devices benefit from extended transition periods (until 2027 for Class III/IIb custom implantables, and 2028 for Class IIb/IIa/I sterile) only if the manufacturer has lodged a formal application with a notified body by the required deadline and established an MDR-compliant QMS.
For companion diagnostic manufacturers navigating dual US and EU regulatory changes, review our guide on EU IVDR change control.
Technical Data Integration: XML Bulk Uploads & Machine-to-Machine (M2M) APIs
For large medtech enterprises managing thousands of global SKUs, manual web UI registration in EUDAMED is operationally unfeasible. The European Commission provides machine-to-machine (M2M) data exchange capabilities based on XML messaging protocols.
EUDAMED Machine-to-Machine (M2M) Data Flow
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[Enterprise Regulatory RIM System] ---> [XML Payload Generation] ---> [AS4 Security Gateway]
|
v
[EUDAMED Production System] <--- [Validation & ACK Response] <--- [EC M2M Endpoint]
Key Technical Integration Specifications
- AS4 Messaging Protocol: Data submission uses the eDelivery AS4 profile, establishing encrypted, authenticated transport between the manufacturer's Regulatory Information Management (RIM) system and EUDAMED servers.
- Basic UDI-DI & UDI-DI XML Schemas: Data payloads must strictly conform to European Commission XSD schemas. Common validation errors include invalid GMDN/EMDN nomenclature codes, mismatched trade names, or missing clinical attributes.
- Automated Validation & Acknowledgment: Submissions trigger synchronous AS4 receipt acknowledgments followed by asynchronous validation reports (XML ACK/NACK). Errors must be remediated within internal quality workflows.
Summary of Safety and Clinical Performance (SSCP) & Post-Market Clinical Follow-Up (PMCF) Integration
Under Article 32 of Regulation (EU) 2017/745, manufacturers of Class III devices and implantable devices must draw up a Summary of Safety and Clinical Performance (SSCP). The SSCP represents a public clinical document uploaded to EUDAMED to provide clinicians and patients with transparent access to clinical evidence.
SSCP & Post-Market Clinical Follow-Up (PMCF) Integration
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[Clinical Evaluation Report (CER)] ---> [Notified Body Review & Approval]
|
v
[Public EUDAMED SSCP Upload] <--- [Annual PMCF Evaluation Update]
Critical Requirements for SSCP Publication
- Dual Audience Sections: The SSCP must contain separate, clearly distinguished sections: one formatted for healthcare professionals (including technical clinical trial data and residual risks) and one written in clear language suitable for patients.
- Linkage to Basic UDI-DI: Each SSCP document registered in the UDI/Device module is permanently linked to the primary Basic UDI-DI of the device family.
- Annual PMCF Updates: For Class III and custom implantable devices, the SSCP must be updated annually in EUDAMED with fresh Post-Market Clinical Follow-Up (PMCF) evaluation data and Periodic Safety Update Reports (PSUR).
EUDAMED Public Search & Transparency for Hospital Procurement & Competitive Intelligence
Beyond regulatory compliance, the mandatory go-live of EUDAMED transforms commercial intelligence and hospital procurement across the 27 EU member states.
EUDAMED Public Transparency & Data Access Architecture
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Public Users / EU Hospitals / Competitor Analysts
|
+---> [Actor Search] --------> Verify Manufacturer SRN & AR Legitimacy
|
+---> [UDI/Device Search] ---> Access Basic UDI-DI & EMDN Categories
|
+---> [Certificate Search] --> Inspect Active NB Certificates & Expiry
|
+---> [SSCP Documents] ------> Download Summary of Safety & Clinical Performance
Strategic Use Cases for Health Systems & Industry Analysts
- Hospital Procurement Verification: EU hospital procurement teams can directly query EUDAMED to verify that a supplier's Single Registration Number (SRN) and device UDI-DI registrations are active before awarding public tender contracts.
- Summary of Safety and Clinical Performance (SSCP): For Class III and implantable devices, EUDAMED mandates public access to the manufacturer's SSCP document. Clinicians and P&T committees can evaluate clinical trial data, residual risk profiles, and post-market clinical follow-up (PMCF) results.
- Competitor Portfolio Tracking: Medtech strategy teams can monitor competitors' regulatory filings, tracking new Basic UDI-DI registrations to identify upcoming product line expansions before commercial launch.
- Authorised Representative Audit: Non-EU manufacturers can audit their designated Authorised Representative's public SRN registry to ensure all imported device lines are correctly linked.
Key Compliance Actions for MedTech Teams Before Nov 27, 2026
EUDAMED Compliance Implementation Roadmap
========================================
Step 1: Obtain SRN ---> Step 2: Basic UDI-DI ---> Step 3: Legacy Linkage ---> Step 4: Verification
------------------ ------------------- ---------------------- -------------------
Validate Actor Assign Basic UDI-DI Register MDD/IVDD Re-verify SRN &
details in Actor & UDI-DI in UDI legacy devices before Certificate links
Module Module Nov 27, 2026 annually
- Re-Verify SRN Data Accuracy: Ensure that legal entity name, address, and designated Authorised Representative details match across EUDAMED, ISO 13485 certificates, and physical device labeling.
- Audit Legacy Device Portfolios: Inventory all Directive-compliant devices (MDD 93/42/EEC, AIMDD 90/385/EEC, IVDD 98/79/EC) still placed on the market. Complete EUDAMED UDI/Device registration before the November 27, 2026 mandatory cutoff.
- Harmonize Basic UDI-DI Groupings: Ensure that device families share correct Basic UDI-DI identifiers to prevent duplicate entry errors that complicate vigilance tracking.
- Coordinate with EU Importers: Confirm that EU-based importers have registered in EUDAMED and linked their SRN to the manufacturer's profile to prevent customs holds at Union borders.
- Establish Post-Market Audit Readiness: Ensure internal Quality Management Systems (QMS) incorporate EUDAMED SRN and UDI verification into annual management review protocols.
Frequently Asked Questions (FAQ)
When did EUDAMED become mandatory?
Four core EUDAMED modules (Actor, UDI/Device, Certificates, Market Surveillance) became mandatory on May 28, 2026, six months after the European Commission published Decision (EU) 2025/2371.
What is the deadline for registering legacy devices in EUDAMED?
Legacy devices (marketed under former directives MDD, AIMDD, or IVDD) that continue to be placed on the EU market must be fully registered in EUDAMED by November 27, 2026.
Do non-EU manufacturers need an SRN before exporting devices to Europe?
Yes. Non-EU manufacturers must register in the Actor Module through their designated EU Authorised Representative to obtain a Single Registration Number (SRN) before placing devices on the EU market.
Sources
- European Commission: EUDAMED Overview and Mandatory Implementation Timelines. DG Health and Food Safety (SANTE), 2026. https://health.ec.europa.eu/medical-devices-eudamed/overview_en
- EUR-Lex: Regulation (EU) 2024/1860 of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the gradual roll-out of EUDAMED. Official Journal of the European Union.
- European Commission: Commission Implementing Decision (EU) 2025/2371 on the publication of the notice concerning full functionality of EUDAMED modules. OJEU, November 27, 2025.
- European Commission NANDO Database: New Approach Notified and Designated Organisations. List of Designated Notified Bodies under Regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR).
- U.S. Food and Drug Administration: Unique Device Identification System (UDI System) and Global UDI Database (GUDID) Technical Guidance. https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system
- European Commission: EUDAMED — European Database on Medical Devices (public modules: Actors, UDI/Devices, Certificates and Notified Bodies, Market Surveillance). Device, economic-actor, and certificate aggregates referenced in this analysis are drawn from the public EUDAMED registry. https://ec.europa.eu/tools/eudamed/
- QBD Group: EU MDR & EUDAMED Implementation Analysis: Navigating Notified Body Capacity and Mandatory Deadlines in 2026. Trade Compliance Review.
