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Under EU MDR 2017/745^[1] and EU IVDR 2017/746^[2], all medical device actors (manufacturers, authorized representatives, importers, distributors) must register in EUDAMED and obtain a Single Registration Number (SRN) before placing devices on the EU market^[1][2].

This requirement applies to:

• Manufacturers placing devices on the EU market^[1] — must obtain manufacturer SRN and register devices in EUDAMED^[1]
• Authorized representatives representing non-EU manufacturers^[1] — must obtain AR SRN and may need to register devices on behalf of manufacturers^[1]
• Importers and distributors — must register as actors in EUDAMED and obtain SRNs^[1]
• Companies with complex portfolios needing device and UDI registration support — large portfolios benefit from specialized EUDAMED support
• New market entrants entering the EU market for the first time — EUDAMED registration is mandatory before market access^[1]

Note: The SRN is mandatory and required before any other EUDAMED activities^[1]. EUDAMED registration support can help streamline the process, especially for complex portfolios or companies new to EUDAMED. EUDAMED is the European Database on Medical Devices, serving as the central hub for device registration, UDI, certificates, clinical investigations, and vigilance reporting^[1].

EUDAMED registration support (also called EUDAMED support services or EUDAMED registration assistance) typically includes:

• Actor registration: Assisting with actor registration and SRN application^[1] — manufacturers, authorized representatives, importers, and distributors must register as actors^[1]
• SRN support: Helping obtain your Single Registration Number (SRN)^[1] — the SRN is issued by the competent authority and is required before any other EUDAMED activities^[1]
• UDI registration: Supporting UDI assignment and device registration^[1] — UDI must be assigned to devices and registered in EUDAMED^[1]
• Device registration: Assisting with device registration workflows^[1] — devices must be registered in EUDAMED before being placed on the market^[1]
• Certificate management: Supporting certificate uploads and management^[1] — certificates must be registered in EUDAMED^[1]
• Clinical investigation registration: Supporting clinical investigation notifications and registrations^[1] — clinical investigations must be registered in EUDAMED^[1]
• Vigilance module support: Assisting with incident reporting and field safety corrective actions^[1] — serious incidents must be reported through EUDAMED^[1]
• Training and enablement: Some providers offer training so you can manage EUDAMED yourself — training can help reduce long-term costs
• Ongoing maintenance: Support for updates, changes, and ongoing compliance — EUDAMED requires ongoing maintenance as devices change^[1]

Important: EUDAMED registration is mandatory under MDR/IVDR^[1][2], and devices cannot be placed on the market without proper EUDAMED registration^[1].

EUDAMED registration support pricing (also called EUDAMED support cost or EUDAMED registration fees) varies based on several factors:

• Modules needed: Actor/SRN registration, UDI registration, device registration, certificate management, clinical investigation registration, vigilance reporting^[1] — more modules typically cost more
• Portfolio size: Number of devices and device families — larger portfolios require more registration work and typically cost more^[1]
• Service scope: One-time setup vs. ongoing managed services — managed services typically cost more but provide ongoing support^[1]
• Training included: Whether training and enablement are included — training can help you manage EUDAMED yourself but may add to initial costs
• Data complexity: Complexity of UDI data and device information — complex UDI data requires more preparation and validation^[1]
• Actor type: Manufacturer, authorized representative, importer, or distributor — different actor types have different registration requirements^[1]
• Contract terms: One-time fees vs. ongoing retainer — retainer models are common for ongoing EUDAMED maintenance^[1]

Pricing models: Most providers offer one-time setup fees for initial registration plus ongoing retainer fees for maintenance and updates^[1]. Some providers charge per device or per module.

When selecting an EUDAMED registration support provider (also called EUDAMED support provider or EUDAMED registration service), consider these factors:

1. EUDAMED experience: Verify experience with EUDAMED and successful registrations^[1] — EUDAMED is complex and requires specialized knowledge^[1]. Ask about number of successful registrations and years of experience.
2. Module coverage: Confirm support for all modules you need^[1] — actor/SRN registration, UDI, device registration, certificates, clinical investigations, vigilance^[1]. Some providers specialize in specific modules.
3. Actor type experience: Verify experience with your role (manufacturer, authorized representative, importer, distributor)^[1] — different actor types have different registration requirements^[1].
4. Data management: Assess their data handling and accuracy processes^[1] — EUDAMED requires accurate data, and errors can delay registration^[1]. Verify data validation and quality processes.
5. Training options: Check if they offer training for self-management — training can help reduce long-term costs and give you control over EUDAMED.
6. Ongoing support: Evaluate maintenance and update support options^[1] — EUDAMED requires ongoing maintenance as devices change and regulations update^[1].
7. Technology: Assess online portals, data import/export, integration capabilities — good technology can streamline the registration process and reduce errors.
8. Response times: Verify SLA for registration activities — EUDAMED registration is time-sensitive, especially for market entry^[1].

Recommendation: Request references from providers, ask about their largest clients and most complex portfolios, and verify their understanding of EUDAMED's evolving requirements^[1]. EUDAMED registration is mandatory^[1], so choose a provider with proven experience.