EUDAMED at Scale: 1.29 Million UDI-DIs Reveal Who Supplies the EU Device Market

Executive Summary

EUDAMED — the European Database on Medical Devices — became mandatory on 28 May 2026 for actor registration, UDI/Device data, certificates, and market surveillance. With the compliance deadline now in effect, the database offers an unprecedented view of the EU medical device supply landscape.

Our analysis of the complete EUDAMED UDI/Device public dataset (extracted March 2026) covering 1,292,737 UDI-DI records reveals a market where four countries supply nearly half of all registered devices, Turkey punches far above its weight in high-risk Class III devices, and the vast majority of registrations remain actively on the market. This article quantifies the risk-class distribution, manufacturer-origin country concentration, and market-status patterns that will shape EU device supply chains as EUDAMED transitions from voluntary to mandatory.

Data Source and Method

• Source: EU public EUDAMED database, UDI/Device module

• Analysis sample: EUDAMED public device extract dated March 2026 (1,292,737 UDI-DI records)

• Scope: All device records with manufacturer SRN (Single Registration Number) data

• Analysis date: 9 June 2026

• Computed using: MedDeviceGuide analysis of the EUDAMED public device extract

• Limitations: The dataset reflects voluntary registrations as of March 2026 and may not include all devices placed on the EU market. Mandatory registration from May 2026 onward will expand coverage. Manufacturer country was derived from the SRN country prefix (e.g., CN-MF-, DE-MF-, TR-MF-).

EUDAMED at a Glance

The near-total "on the market" status confirms that EUDAMED's voluntary phase captured primarily active devices. The 1.2% withdrawal rate is remarkably low for a database of this size, though this may rise as legacy MDD/IVDD devices approach their transition deadlines.

Risk Class Distribution: Class I Dominates

EUDAMED uses the MDR risk classification system for medical devices and the IVDR classification for in vitro diagnostics:

Class I and IIa together account for 76.6% of all UDI-DIs. This is consistent with the broader device market: low-risk products (surgical instruments, dressings, examination gloves, dental consumables) have far more individual SKU-level variants than high-risk implantable devices. The relatively modest 3.9% share of Class III devices reflects the higher regulatory barrier and narrower product scope for implantable and life-sustaining devices.

IVD devices represent approximately 5.7% of all records (Class A, B, C plus IVD-specific categories), suggesting significant IVDR registration activity remains ahead.

Manufacturer-Origin Country Ranking: China Leads, Four Countries Supply 50%

By extracting the two-letter country prefix from each manufacturer's SRN, we can map every UDI-DI back to the manufacturer's registered country of origin. The top 20 countries paint a striking picture:

Just four countries — China, Turkey, the US, and Germany — supply 49.6% of all EUDAMED UDI-DIs. Ten countries cover 73.2%, and the top 20 account for 91.3%. This concentration has direct implications for EU supply chain resilience, which the EU MDR's Article 10a shortage-notification requirement (effective January 2025 under Regulation 2024/1860) is designed to address.

China: Volume Leader Across All Risk Classes

China's 246,536 UDI-DIs are distributed across risk classes as follows:

China leads in both absolute volume and breadth of coverage. Unlike other major origins that skew toward low-risk devices, China has a substantial Class IIa footprint (39.8%) and contributes 3,897 Class III UDI-DIs — more than any country except Turkey and Germany.

Turkey: Disproportionate High-Risk Presence

Turkey's risk-class profile is unlike any other top-origin country:

Turkey contributes 15,068 Class III UDI-DIs — the highest Class III count of any country in the database, and 29.8% of all Class III registrations. This is an extraordinary concentration. Turkey's 10.3% Class III rate is more than six times the Class III share of the US (1.7%) and nearly double that of Germany (5.4%). Turkey also holds 17.9% of all Class IIb registrations (31,821 of 178,188).

This pattern likely reflects Turkey's significant surgical instrument manufacturing sector — companies based in Samsun and other industrial hubs produce large catalogs of orthopedic, dental, and surgical devices that are classified as Class IIb and Class III under MDR rules.

United States: Skews Low-Risk, Broad Manufacturer Base

Over half of US-sourced UDI-DIs are Class I, consistent with the US device market's large base of low-risk consumables, physical medicine products, and general hospital supplies.

Germany: Balanced Portfolio with Strong Class III Presence

Germany shows the most balanced risk distribution among the top four origins. Its 5.4% Class III rate is second only to Turkey, and its Class IIa share (37.0%) reflects the diversity of the German medical technology industry, which spans surgical instruments, imaging, cardiovascular, and orthopedic devices.

Market Status: Who Is Withdrawing?

The EUDAMED dataset tracks three device statuses: "on the market," "no longer on the market" (withdrawn), and "not intended for EU market."

Withdrawal Rate by Country (Top Origins)

The most striking outlier is Finland at 16.1% withdrawal — nearly 1 in 6 Finnish-sourced UDI-DIs are marked as no longer on the market. This likely reflects legacy device rationalization by Finnish manufacturers consolidating portfolios under MDR, rather than active market exits. Among large-origin countries, France (3.4%), Switzerland (3.7%), and India (3.7%) show the highest withdrawal rates.

Turkey, Israel, and Pakistan show near-zero withdrawal, suggesting these manufacturers are actively maintaining their EUDAMED registrations.

Withdrawal Rate by Risk Class

Class III devices have the highest withdrawal rate at 3.0% — more than three times the Class I rate. This is consistent with the higher regulatory burden of maintaining Class III conformity assessment under MDR, where manufacturers may choose to discontinue devices rather than invest in renewed Notified Body certification.

Top 10 Manufacturers by UDI-DI Count

The top manufacturers are dominated by dental, orthopedic, and surgical instrument companies — product categories with enormous SKU counts due to size variants, material options, and kit configurations. Yamahachi Dental alone accounts for 4.3% of all UDI-DIs. Three of the top 10 manufacturers are Turkish surgical instrument companies, reinforcing Turkey's outsized presence.

Practical Implications

1. Supply Chain Concentration Risk

With four countries supplying nearly half of all EUDAMED UDI-DIs and just 20 countries covering 91.3%, the EU device market is geographically concentrated. Article 10a of the MDR (introduced by Regulation 2024/1860, effective January 2025) now requires manufacturers to notify competent authorities of supply interruptions that could cause serious harm. The data suggests that monitoring should prioritize the top-origin countries where withdrawal rates are rising (France, Switzerland, India) and the high-risk segments (Class III) where withdrawal is most common.

2. Turkey's Strategic Importance

Turkey's dominance in Class III and Class IIb devices — 29.8% and 17.9% of those categories respectively — means that any regulatory disruption affecting Turkish manufacturers could have outsized impact on the supply of orthopedic, surgical, and dental implant devices in the EU. Importers, distributors, and procurement organizations should maintain visibility into the regulatory status of key Turkish manufacturers.

3. IVD Registration Gap

IVD devices represent only 5.7% of EUDAMED UDI-DIs, despite IVDR's full application since May 2022. This suggests that many IVD manufacturers have not yet completed voluntary registration, and the mandatory deadline (legacy devices by November 2026) will trigger a significant wave of new registrations.

4. EUDAMED as a Competitive Intelligence Tool

As EUDAMED becomes the authoritative record of all devices on the EU market, manufacturers can use the public data to benchmark their own registration volumes against competitors, identify market segments with high concentration or high withdrawal, and track the geographic diversification of their supply chains.

Source Notes

• Data source: EU public EUDAMED database, UDI/Device module; analysis by MedDeviceGuide, run date 2026-06-09.

• Analysis sample: EUDAMED public device extract dated March 2026, 1,292,737 UDI-DI records.

• Manufacturer country derived from the SRN two-letter prefix (e.g., CN-MF-, DE-MF-, TR-MF-).

• EUDAMED mandatory deadline: Commission Decision (EU) 2025/2371 declared the Actor, UDI/Device, Certificates, and Market Surveillance modules functional; mandatory use from 28 May 2026 per Regulation (EU) 2024/1860 transitional provisions.

• Legacy device deadline: 27 November 2026.