EUDAMED Actors by the Numbers: 48,071 Manufacturers, Importers, and ARs (2026)
A deep quantitative teardown of the EUDAMED Actor module. Analysis of role distribution, country concentration, non-EU manufacturer dependencies, and EU Authorised Representative capacity.
The European Database on Medical Devices (EUDAMED) is no longer a voluntary repository or a compliance project in transition. Regulation (EU) 2024/1860 set the framework for EUDAMED to go live module by module, and Commission Decision (EU) 2025/2371 (published 27 November 2025) declared the Actor module functional and triggered a six-month transition — so the mandatory actor-registration deadline of May 28, 2026 has now passed. Every manufacturer, importer, authorised representative, and system/procedure pack producer placing medical devices or in vitro diagnostics (IVDs) on the European Union market must hold a validated Single Registration Number (SRN) generated by EUDAMED's Actor registration module.
For regulatory affairs directors and market-access strategists, EUDAMED is more than a registration gate. It is a massive, public market-intelligence database. By analyzing the cohort of economic operators who have successfully obtained SRNs, we can map the true shape of MedTech commerce in Europe: which manufacturing nations lead the market, how heavily the EU depends on foreign supply, and where the administrative bottlenecks lie for companies entering the European market.
This article delivers a complete quantitative teardown of EUDAMED’s actor population. Based on a direct analysis of 48,071 registered economic operators, we break down the counts by role, analyze country concentration, evaluate the dependency of non-EU manufacturers on European partners, and highlight the critical bottleneck in Authorised Representative (AR) capacity.
For a broader look at EUDAMED’s other modules, see our EUDAMED device database UDI/DI country and risk-class analysis, our EU notified body certificate expiry cliff analysis, and our core EUDAMED registration guide.
1. The Macro Picture: EUDAMED Actor Roles by the Numbers
To understand EUDAMED’s structure, we must first look at the four distinct roles defined under the Medical Devices Regulation (MDR - Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR - Regulation (EU) 2017/746). Every registered actor holds an SRN tied to one of these roles:
- Manufacturer (MF): The natural or legal person responsible for the design, manufacture, packaging, and labeling of a device before it is placed on the market under their own name.
- Authorized Representative (AR): Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer located outside the Union to act on their behalf in relation to specified tasks under the MDR/IVDR.
- Importer (IM): Any natural or legal person established within the Union who places a device from a third country on the Union market.
- System and Procedure Pack Producer (PR): Any natural or legal person who puts devices bearing a CE marking together with other devices or products, in a manner compatible with the intended purpose of the devices or other products, to place them on the market as a system or procedure pack.
Our analysis of EUDAMED's actor module reveals a total of 48,071 economic operators with active registrations. The distribution of these actors across the four roles is detailed in the table below:
Table 1: EUDAMED Registered Actor Roles
| Actor Role | Registered Operators | Share of Total Actors (%) | Primary Regulatory Duty |
|---|---|---|---|
| Manufacturer | 31,554 | 65.64% | Full product compliance, QMS implementation, technical documentation |
| Importer | 11,984 | 24.93% | Verifying CE mark, labeling compliance, storage, and transport |
| Authorised Representative | 2,907 | 6.05% | Legal representation for non-EU manufacturers, regulatory liaison |
| System/Procedure Pack Producer | 1,626 | 3.38% | Assembly of CE-marked devices, compatibility certification |
| Total Registered Actors | 48,071 | 100.00% | Comprehensive EU MedTech supply chain footprint |
Data source: EUDAMED Actor Module public extract; analysis by MedDeviceGuide.
Several regulatory implications emerge from this high-level split:
- Manufacturer Dominance: Nearly two-thirds of all registered entities are manufacturers. This reflects the highly fragmented nature of the MedTech manufacturing landscape, which features thousands of small-to-medium enterprises (SMEs) alongside global conglomerates.
- The Importer-to-Manufacturer Ratio: There is approximately one registered importer for every 2.6 registered manufacturers. Under MDR/IVDR Article 13, importers bear strict compliance duties, including verifying that the manufacturer has registered the device in EUDAMED and that a valid CE certificate is in place. The relatively high number of registered importers (11,984) indicates that many manufacturers maintain multiple distributor channels rather than relying on a single import hub.
- The Authorised Representative Bottleneck: With only 2,907 registered ARs serving the entire global cohort of non-EU manufacturers, each AR represents a critical point of regulatory failure. If a single AR’s registration is suspended or revoked due to non-compliance, all foreign manufacturers mandating that AR lose their legal market access overnight.
2. Anatomy of the Single Registration Number (SRN)
A key output of EUDAMED Actor registration is the Single Registration Number (SRN). The SRN uniquely identifies every economic operator in the European Union, preventing duplication of registrations across multiple national competent authorities.
Every SRN follows a strict, standardized format that allows regulatory bodies, notified bodies, and customs officers to instantly decode the operator's jurisdiction and role. The structure is composed of three parts:
[Country Code]-[Role Code]-[9-Digit Unique ID]
Where:
- Country Code: Represents the ISO 3166-1 alpha-2 code of the country where the operator is established (e.g.,
DEfor Germany,NLfor the Netherlands,CNfor China). - Role Code: Identifies the operator's specific regulatory role. These codes are:
MFfor ManufacturersARfor Authorised RepresentativesIMfor ImportersPRfor System/Procedure Pack Producers
- 9-Digit Unique ID: A sequential numeric string assigned automatically by EUDAMED upon validation of the registration.
Examples of SRN Structures
DE-MF-000012345: A medical device manufacturer established in Germany.NL-AR-000054321: An Authorised Representative established in the Netherlands.CN-MF-000098765: A medical device manufacturer established in China. Note that even though the manufacturer is outside the EU, their SRN country prefix matches their country of origin (CN), while their registration is linked to their mandated EU AR.
This unified formatting allows European customs authorities to cross-reference shipping manifests directly against the EUDAMED database. If a foreign manufacturer’s SRN does not match the mandated AR listed on the product label, or if the importer’s SRN is inactive, customs can immediately impound the shipment.
3. Country Concentration: Where EUDAMED Actors Are Established
Where do the businesses driving the European medical device market reside? By grouping EUDAMED actors by their country of establishment, we can identify the nations that dominate MedTech manufacturing and import.
The dataset lists operators across more than 100 countries. The table below lists the top 15 countries by total registered actors, spanning all four roles:
Table 2: Top 15 Countries by Registered EUDAMED Actors (All Roles)
| Rank | Country | Registered Actors | Share of Global Total (%) | Regional Designation |
|---|---|---|---|---|
| 1 | China | 7,311 | 15.21% | Non-EU |
| 2 | Germany | 6,781 | 14.11% | EU Member State |
| 3 | Italy | 4,172 | 8.68% | EU Member State |
| 4 | France | 3,084 | 6.42% | EU Member State |
| 5 | United States | 2,601 | 5.41% | Non-EU |
| 6 | Netherlands | 2,403 | 5.00% | EU Member State |
| 7 | Spain | 2,096 | 4.36% | EU Member State |
| 8 | Türkiye | 1,753 | 3.65% | EU Extended (Customs Union) |
| 9 | Poland | 1,527 | 3.18% | EU Member State |
| 10 | United Kingdom | 1,097 | 2.28% | Non-EU |
| 11 | Sweden | 996 | 2.07% | EU Member State |
| 12 | South Korea | 978 | 2.03% | Non-EU |
| 13 | Czechia | 878 | 1.83% | EU Member State |
| 14 | Belgium | 862 | 1.79% | EU Member State |
| 15 | Romania | 856 | 1.78% | EU Member State |
Data source: EUDAMED Actor Module public extract; analysis by MedDeviceGuide. Note: UK data represents Great Britain registrations; Northern Ireland economic operators are classified under the EU framework.
Analysis of the Country Distribution
- China is the Single Largest Contributor: With 7,311 registered economic operators, China has surpassed every individual EU member state in total actor count. This massive volume is driven almost entirely by manufacturers of single-use devices, hospital consumables, personal protective equipment (PPE), and low-risk IVD reagents.
- Germany Leads the European Union: Within the EU, Germany remains the undisputed powerhouse of MedTech, with 6,781 registered actors (14.11% of the global total). Germany’s high count is a product of its mature domestic manufacturing base, its dense network of specialized importers, and its concentration of professional Authorised Representatives.
- The Non-EU Share is Significant: If we aggregate actors by regional status, we find that 33.56% of all registered economic operators (16,132 actors) are established outside the European Union. These operators must work through EU-based partners (ARs and Importers) to legally access the single market.
4. The Non-EU Manufacturer Cohort: Mapping AR Dependencies
Under MDR/IVDR Article 11, any manufacturer located outside the 27 EU Member States (plus the EEA/EFTA countries that participate in EUDAMED) cannot place devices on the market without designating a single Authorised Representative.
By isolating the Manufacturer role within the dataset and filtering by country type, we find that 15,762 registered manufacturers are located outside the EU. This represents 49.95% of all registered manufacturers in EUDAMED. Half of the entities designing and building medical devices for European patients are foreign companies dependent on an EU partner for regulatory representation.
The table below breaks down the top 10 non-EU manufacturing countries whose companies rely on EU Authorised Representatives:
Table 3: Top 10 Non-EU Manufacturing Nations in EUDAMED
| Rank | Non-EU Country | Registered Manufacturers | Share of Non-EU Manufacturer Cohort (%) | Primary Device Types |
|---|---|---|---|---|
| 1 | China | 7,247 | 45.98% | Consumables, surgical instruments, low-risk IVDs |
| 2 | United States | 2,475 | 15.70% | High-risk implants, active electronics, software (SaMD) |
| 3 | United Kingdom | 1,042 | 6.61% | Cardiovascular, orthopedic, digital health |
| 4 | South Korea | 976 | 6.19% | In vitro diagnostics, aesthetic devices, imaging systems |
| 5 | Switzerland | 527 | 3.34% | Dental implants, precision instruments, active implants |
| 6 | Pakistan | 524 | 3.32% | Reusable stainless-steel surgical instruments |
| 7 | India | 498 | 3.16% | Orthopedic implants, wound care, consumables |
| 8 | Taiwan | 402 | 2.55% | Home-use electronics, thermometers, wheelchairs |
| 9 | Israel | 390 | 2.47% | Medical lasers, active electronics, digital health |
| 10 | Japan | 261 | 1.66% | Endoscopes, diagnostic imaging, catheter systems |
Data source: EUDAMED Actor Module public extract; analysis by MedDeviceGuide.
Key Takeaways from the Non-EU Manufacturer Cohort
- China’s Manufacturer Concentration: Of the 7,311 total Chinese actors in EUDAMED, 7,247 are manufacturers. Only a tiny fraction are SPPPs. This means that nearly 46% of all foreign manufacturers in EUDAMED are located in China. These manufacturers represent a massive volume of low-to-moderate-risk products that require processing by EU Notified Bodies and EU Authorized Representatives.
- The US High-Value Segment: While the US has fewer manufacturers in EUDAMED (2,475) than China, these companies represent a disproportionate share of Class IIb and Class III devices. The US regulatory footprint is characterized by complex, clinical-evidence-heavy submissions.
- The Post-Brexit and Post-MRA Cohorts: The UK (1,042 manufacturers) and Switzerland (527 manufacturers) are major historical suppliers to the EU. Following Brexit and the lapse of the Swiss-EU Mutual Recognition Agreement (MRA) for medical devices, these close neighbors became "third countries." Their presence in the non-EU cohort highlights the administrative friction introduced by political shifts; over 1,500 manufacturers that previously traded freely now require dedicated ARs and importers.
5. The Authorised Representative Bottleneck
Because 15,762 foreign manufacturers require an EU Authorised Representative, we must look closely at where these representatives are located. In EUDAMED, there are only 2,907 registered Authorised Representatives.
On average, this represents a ratio of 5.4 foreign manufacturers per EU Authorised Representative. In reality, the market is highly concentrated, with a small number of professional, high-volume AR consultancies representing hundreds of manufacturers, while smaller, local entities represent only one or two.
The table below maps the geographic concentration of EUDAMED Authorised Representatives:
Table 4: EU Authorised Representatives by Country of Establishment
| Rank | EU Country | Registered Authorised Representatives (AR) | Share of Total EU AR Capacity (%) | Primary Market Attractiveness |
|---|---|---|---|---|
| 1 | Germany | 764 | 26.28% | Largest domestic market, established regulatory hubs |
| 2 | Netherlands | 386 | 13.28% | Logistics hub, English-language business environment |
| 3 | France | 264 | 9.08% | Access to French-speaking markets, domestic MedTech presence |
| 4 | Italy | 263 | 9.05% | Large manufacturing sector, Southern Europe gateway |
| 5 | Ireland | 221 | 7.60% | Only native English-speaking EU member (post-Brexit), tax benefits |
| 6 | Spain | 195 | 6.71% | Access to Iberian peninsula, Latin American connections |
| 7 | Belgium | 101 | 3.47% | Proximity to EU institutions, central European logistics |
| 8 | Sweden | 72 | 2.48% | Nordic market gateway, high digital health focus |
| 9 | Türkiye | 60 | 2.06% | Non-EU AR (acting under specific customs union agreements) |
| 10 | Austria | 52 | 1.79% | Central/Eastern Europe gateway, German-speaking alignment |
Data source: EUDAMED Actor Module public extract; analysis by MedDeviceGuide.
Why the AR Location Matters
- Germany is the Center of Gravity: Over a quarter of all EU Authorised Representatives are based in Germany. This is driven by Germany’s historical dominance under the old Medical Devices Directive (MDD), where German Notified Bodies and representatives handled a vast share of global CE marking.
- The Benelux and Ireland Advantage: Together, the Netherlands (386), Ireland (221), and Belgium (101) hold 24.35% of all AR capacity. Foreign manufacturers, particularly those from the US and Asia, favor these countries because of their highly professionalized, English-speaking regulatory consultancies, favorable corporate tax rates, and world-class import logistics.
- Competent Authority Oversight Variances: While the MDR/IVDR is a unified regulation, it is enforced by national Competent Authorities (such as BfArM in Germany, IGJ in the Netherlands, and HPRA in Ireland). Competent Authorities inspect the ARs registered in their jurisdiction. ARs in countries with highly active authorities face frequent audits of their mandated manufacturers’ technical documentation. As a result, professional ARs are becoming more selective, demanding thorough technical file reviews of foreign manufacturers before accepting a mandate.
6. The Actor Validation Process: Behind the Scenes
Obtaining an SRN is not as simple as filling out a web form. Once an economic operator submits their registration request in EUDAMED, it must undergo a rigorous validation process before the number is activated. This process varies depending on the actor's role and location:
Step 1: Submission and mandate verification
For a non-EU manufacturer, their chosen Authorised Representative must log into EUDAMED and initiate the request. The AR must upload the signed mandate agreement (meeting all requirements of MDR/IVDR Article 11 and 12) and link the manufacturer's corporate details to the AR's own profile.
Step 2: Competent Authority Audit
Once the registration is submitted, it is routed to the national Competent Authority (CA) of the member state where the applicant (or their AR) is established. For example, if your AR is in the Netherlands, the Dutch Health and Youth Care Inspectorate (IGJ) reviews the application.
The CA verifies:
- The legal registration of the local entity (e.g., verifying business registry numbers).
- The validity of the mandate upload for foreign manufacturers.
- The presence of a designated Person Responsible for Regulatory Compliance (PRRC), including verifying their qualifications, CV, and employment status. Under MDR Article 15, every manufacturer and AR must have at least one PRRC.
Step 3: SRN Generation and Publication
If the CA identifies any deficiencies (e.g., missing PRRC details or formatting errors in the mandate), they reject the request and return it to the applicant for modification. If the request is approved, EUDAMED generates the SRN, changes the actor status to "Active," and publishes the details in the public directory.
Because national CAs face staff shortages, the validation queue can range from 2 weeks to over 3 months. Foreign manufacturers planning a European launch must budget for this CA validation buffer; you cannot upload devices or list UDI details in EUDAMED until your manufacturer SRN is active.
7. Registration Growth Trend: The Post-Deadline Reality
How did we reach 48,071 registered actors? EUDAMED was launched in late 2020 with the opening of the Actor Registration module. By tracing the year of registration for active economic operators, we can see how regulatory deadlines drive compliance behavior.
The chart below shows EUDAMED actor registrations by calendar year:
Table 5: EUDAMED Actor Registrations by Year (2020–2026)
| Year | Registered Actors in Year | Cumulative Actor Population | Key Regulatory Milestone |
|---|---|---|---|
| 2020 | 404 | 404 | Actor module launch (December 2020) |
| 2021 | 15,145 | 15,549 | MDR Date of Application (May 26, 2021) |
| 2022 | 11,156 | 26,705 | IVDR Date of Application (May 26, 2022) |
| 2023 | 5,855 | 32,560 | Legislative extension of MDR transition timelines |
| 2024 | 5,414 | 37,974 | Article 10(a) supply interruption warning obligation |
| 2025 | 4,970 | 42,944 | Mandatory EUDAMED implementation proposal |
| 2026 | 5,126 | 48,071 | Mandatory Actor Module Deadline (May 28, 2026) |
Data source: EUDAMED Actor Module public extract; analysis by MedDeviceGuide. Note: 2026 registrations are partial, covering data through July 8, 2026.
Understanding the Growth Pattern
- The 2021 Surge: The largest single-year spike occurred in 2021 (15,145 registrations). This was driven by the formal Date of Application of the MDR (May 26, 2021). Economic operators rushed to obtain SRNs to place new MDR-compliant devices on the market or to register under the transitional provisions.
- The 2022 Plateau: 2022 saw another 11,156 registrations, driven by the IVDR Date of Application. Many IVD manufacturers, previously accustomed to self-certification, had to register in EUDAMED for the first time.
- The Steady State and the 2026 Deadline Bump: Between 2023 and 2025, registrations settled into a steady state of roughly 5,000 new economic operators per year. However, in the first six months of 2026 alone, EUDAMED added 5,126 actors—surpassing the entire 12-month total for 2025. This surge was the direct result of the May 28, 2026 mandatory registration deadline established under Regulation (EU) 2024/1860. The final cohort of legacy device manufacturers and distributors who had delayed registration were forced to comply or halt operations.
8. What 48,071 Actors Tell Us About EU Market-Entry Strategy
For medical device companies, EUDAMED’s actor distribution reveals several lessons for market-entry strategy:
1. The AR is a Strategic Partner, Not a Post Office
With nearly 16,000 non-EU manufacturers relying on fewer than 3,000 ARs, professional representatives are in high demand. Under MDR/IVDR Article 11, the AR is jointly and severally liable for defective devices placed on the EU market. Consequently, ARs have implemented strict onboarding processes. A foreign manufacturer cannot expect a quick sign-off. You must budget both time and money for a thorough technical documentation audit by the AR before they submit your EUDAMED actor registration.
2. Importer Management is Critical
With 11,984 importers registered, manufacturers must carefully manage their import channels. Every importer must be registered in EUDAMED and hold an active SRN. If you work with multiple independent distributors, each distributor must obtain their own importer SRN and link themselves to your devices in EUDAMED. Alternatively, many manufacturers work with a specialized, independent single importer who handles the EUDAMED link and regulatory compliance, allowing the manufacturer to work with unregistered sub-distributors across different member states.
3. Verification of SRN Validity is Mandatory
Before establishing a commercial relationship with any EU partner, you must verify their registration status. You can search active SRNs directly in the public EUDAMED interface. An invalid or inactive SRN for an AR or importer will block your customs clearance and device registration, halting your supply chain.
EUDAMED Actor Registration FAQ
Is EUDAMED actor registration mandatory in 2026, and since when?
Yes. Actor registration in EUDAMED is mandatory as of May 28, 2026 for all manufacturers, authorised representatives, and importers placing medical devices or IVDs on the EU market. The mandate was triggered by Commission Decision (EU) 2025/2371 (26 November 2025), which declared the Actor module functional; under the transitional provisions of Regulation (EU) 2024/1860, that started a six-month run-up to the 28 May 2026 mandatory date, ahead of the database's still-developing modules. For details on the timeline, see our EUDAMED mandatory registration deadline guide.
Do non-EU manufacturers have to register directly in EUDAMED, or through an Authorised Representative?
A non-EU manufacturer cannot complete their EUDAMED actor registration independently. They must first designate an EU-based Authorised Representative. The AR must review the manufacturer's technical documentation, accept the mandate, and submit the registration request on the manufacturer's behalf. Once the local Competent Authority validates the request, the manufacturer is issued their SRN.
How many of the EUDAMED actors are based outside the EU?
Paralleling the manufacturer role shows that 15,762 manufacturers are non-EU entities, representing 49.95% of all manufacturers registered in EUDAMED. Aggregating all economic operator roles shows that 33.56% of all registered actors (16,132) reside outside the EU.
Which EU country has the most Authorised Representatives available to foreign manufacturers?
Germany is the leading hub for EU Authorised Representatives, holding 764 registered ARs (26.28% of the EU total). The Netherlands follows with 386 ARs (13.28%), with France (264) and Italy (263) close behind.
How often should I expect the EUDAMED actor numbers in this article to change?
EUDAMED is updated in real-time as national Competent Authorities validate new registrations. While the broad percentages (such as China and Germany leading, and non-EU manufacturers representing roughly half the total) remain stable, the absolute counts grow by approximately 400 to 500 new economic operators each month. MedDeviceGuide refreshes its EUDAMED data analysis quarterly.
Data sources: EUDAMED Actor module public extract, snapshot dated 8 July 2026 (48,071 economic-operator records); role, country-of-establishment, non-EU manufacturer, and Authorised Representative aggregates computed by MedDeviceGuide from that snapshot. Legal basis: Commission Decision (EU) 2025/2371 declared the Actor module functional; mandatory use from 28 May 2026 under Regulation (EU) 2024/1860 transitional provisions. Counts are a single 8 July 2026 snapshot and will drift as national Competent Authorities validate new registrations. This article is educational and is not regulatory advice for a specific product or company.