EUDAMED Day Zero: The Role-Specific Action Playbook for Manufacturers, Authorized Representatives, Importers, and Distributors (Final 50 Days Before May 28, 2026)

Day Zero Is May 28, 2026 — Not a Suggestion, a Legal Deadline

On November 27, 2025, the European Commission published Decision (EU) 2025/2371, formally declaring that the first four EUDAMED modules are fully functional. Under Regulation (EU) 2024/1860, this triggered a six-month transition period. On May 28, 2026, use of these four modules becomes legally mandatory — not voluntary, not best-effort, not optional.

The four modules going live on Day Zero are:

1. Actor Registration — registration of all economic operators (manufacturers, authorized representatives, importers, system/procedure pack producers)
2. UDI/Device Registration — registration of all medical devices and IVDs with Unique Device Identification data
3. Notified Bodies and Certificates — registration of notified bodies and their issued certificates
4. Market Surveillance — coordination of market surveillance actions between competent authorities

The Vigilance and Post-Market Surveillance module and the Clinical Investigations and Performance Studies module remain under development and will become mandatory following a separate Commission notice at a later date.

This guide is organized by economic operator role — Manufacturer, Authorized Representative, Importer, and Distributor — because each role has distinct registration obligations, different data requirements, and different timelines. For each role, we provide: (a) what must be entered by when, (b) which modules apply, (c) remaining national registry obligations, (d) a penalty matrix by member state, and (e) a day-by-day countdown checklist.

Key Dates at a Glance

Date	Milestone	What Happens
November 27, 2025	Commission Decision (EU) 2025/2371 published	Six-month countdown begins
May 28, 2026	Day Zero — mandatory use begins	All four modules become legally mandatory. All economic operators must be registered. New devices must be registered before market placement.
November 27, 2026	Transition deadline for legacy devices	Devices already on the market before May 28, 2026 must be registered in EUDAMED by this date. IVDs placed on market before May 28, 2026 also have this deadline.
May 28, 2027	Certificate upload deadline (medical devices and IVDs)	Notified bodies must upload all legacy MDR and IVDR certificates by this date (18 months from the Commission Decision publication date of November 27, 2025). Only the latest version of each certificate and the latest relevant NB decision need to be uploaded.

Role 1: Manufacturers

What Manufacturers Must Register and When

Obligation	Module	Deadline	Key Data Required
Actor Registration (obtain SRN)	Actors	Before May 28, 2026	Organization details, contact information, PRRC details, regulatory role (Manufacturer)
Register new devices placed on market after May 28, 2026	UDI/Devices	Before first market placement after May 28, 2026	Basic UDI-DI, UDI-DI, device description, risk class, intended purpose, labeling, PRRC confirmation
Register devices already on market before May 28, 2026	UDI/Devices	By November 27, 2026	Same device data as above, with legacy device status indicated
Verify certificate data uploaded by Notified Body	NB/Certificates	Ongoing — verify NB uploads match your records	Certificate number, scope, validity dates, device coverage
Respond to market surveillance requests	Market Surveillance	As requested by Competent Authorities	Device documentation, risk analysis, corrective action records

SRN — The Single Registration Number

The SRN is your digital identity in EUDAMED. Without it, you cannot register devices, upload UDI data, or conduct any regulatory activity in the system.

How to obtain your SRN:

1. Your Authorized Representative (EC REP) must first be registered and hold their own SRN.
2. You submit your Actor Registration through EUDAMED with your organization details and PRRC information.
3. Your national Competent Authority validates your submission.
4. Upon validation, your SRN is issued.

Critical bottleneck warning: If your Competent Authority faces a surge of registrations, SRN issuance may be delayed. A delayed SRN blocks device registration, which blocks market access for new products. Start now.

Manufacturer Countdown Checklist (50 Days Out — April 8 to May 28, 2026)

Week	Action Items	Owner
Week 1 (Apr 8–14)	Confirm SRN obtained. If not, submit Actor Registration immediately. Verify EC REP SRN is active. Assign internal EUDAMED coordinator.	RA Manager
Week 2 (Apr 15–21)	Audit device portfolio: identify all devices currently on EU market. Flag devices planned for launch before and after May 28. Prepare Basic UDI-DI and UDI-DI data for all products.	RA/QA Team
Week 3 (Apr 22–28)	Begin UDI/Device data entry for highest-priority products. Verify data quality — over 120 fields per device entry. Confirm risk classifications match NB certificate scope.	RA Team
Week 4 (Apr 29–May 5)	Complete UDI data for all active devices. Cross-check device descriptions against NB certificates. Verify labeling data matches EUDAMED entries — misalignment creates misbranding risk.	RA/QA Team
Week 5 (May 6–12)	Test data integrity: review all entries for completeness. Verify BUDI-DI groupings are correct (devices grouped by same intended purpose, risk class, and essential design). Confirm all device registrations link to valid NB certificates.	RA Manager
Week 6 (May 13–19)	Complete data entry for any remaining products. Verify EC REP linkage is active and correct. Prepare internal SOP for ongoing EUDAMED maintenance (new product registrations, updates, corrections).	RA Manager
Week 7 (May 20–27)	Final review of all registrations. Confirm no pending actions. Brief sales and distribution teams on new market entry requirements (no registration = no market placement after May 28).	RA Director
May 28, 2026	Day Zero. All systems live. No new device can be placed on EU market without EUDAMED registration.	All

What Happens After Day Zero for Manufacturers

• New devices (first placed on market after May 28, 2026): Must be registered in EUDAMED before being placed on the market.
• Legacy devices (already on market before May 28, 2026): Must be registered by November 27, 2026.
• Devices with no remaining sales units from May 28, 2026 onward: Do not require registration, unless a post-market surveillance or vigilance action is initiated. If such action arises later (after the Vigilance module becomes mandatory), the device must be registered retroactively.

Role 2: Authorized Representatives (EC REP)

What EC REPs Must Register and When

Obligation	Module	Deadline	Key Data Required
Actor Registration (obtain SRN)	Actors	Before May 28, 2026	Organization details, contact information, PRRC details, regulatory role (Authorized Representative)
Validate manufacturer Actor Registration requests	Actors	Before manufacturer can obtain SRN	EC REP must be registered first to validate manufacturer requests
Verify UDI/Device data linkage	UDI/Devices	Ongoing	EC REP does NOT upload UDI data but must verify linkage to their SRN
Maintain mandate documentation	Actors	Ongoing — keep mandate current	Updated EC REP mandate agreements

The EC REP's Critical Role in the Registration Chain

The EC REP has a unique position in EUDAMED: they must be registered before the manufacturers they represent can obtain SRNs. This creates a dependency chain:

1. EC REP registers and obtains SRN.
2. Manufacturer registers and requests validation from their EC REP.
3. EC REP validates the manufacturer's registration.
4. Manufacturer SRN is issued after national CA validation.

If your EC REP is not registered, you cannot obtain your SRN. This is the single most common bottleneck reported in early registrations.

EC REP Countdown Checklist

Week	Action Items	Owner
Week 1–2 (Apr 8–21)	Confirm EC REP SRN obtained. If managing multiple mandates, ensure all manufacturer linkages are set up. Verify PRRC details are current.	EC REP Manager
Week 3–4 (Apr 22–May 5)	Validate all pending manufacturer Actor Registration requests. Confirm mandate documentation is complete and current for each manufacturer.	EC REP Compliance
Week 5–6 (May 6–19)	Verify all linked manufacturers have active SRNs. Assist manufacturers with any registration issues. Prepare for post-Day Zero maintenance workflow.	EC REP Manager
Week 7 (May 20–27)	Final confirmation: all mandates active, all manufacturer SRNs issued, all data linkages verified.	EC REP Director

EC REP Note: Termination Visibility

Under EUDAMED, termination of an EC REP's mandate becomes immediately visible in the system. If a manufacturer changes EC REP, the old mandate termination date and new mandate start date are both recorded. Plan transitions carefully — a gap between mandates means the manufacturer has no authorized representative in the EU and their devices cannot legally remain on the market.

Role 3: Importers

What Importers Must Register and When

Obligation	Module	Deadline	Key Data Required
Actor Registration (obtain SRN)	Actors	Before May 28, 2026	Organization details, contact information, regulatory role (Importer)
Verify device registration status	UDI/Devices	Before importing any device after May 28, 2026	Importers do NOT register devices but must verify devices are registered
Maintain import records	Internal	Ongoing	Per MDR Article 13, importers must keep records of devices imported, affixed importer details, and complaints

The Importer's Verification Obligation

Importers have a critical compliance role under EUDAMED: they must verify that devices they import are properly registered. This means:

• Before importing any device after May 28, 2026, the importer should confirm the device has a valid EUDAMED registration.
• Importers must verify that the manufacturer and EC REP are registered actors.
• Importers must verify UDI-DI data is present and matches the device being imported.

Practical implication: If a manufacturer has not registered a device in EUDAMED, the importer cannot legally place it on the EU market. Importers should build EUDAMED verification into their receiving and customs clearance processes.

Importer Countdown Checklist

Week	Action Items	Owner
Week 1–2 (Apr 8–21)	Obtain SRN via Actor Registration. Compile list of all manufacturers and devices imported.	Regulatory/Compliance
Week 3–4 (Apr 22–May 5)	Contact all manufacturers to confirm their EUDAMED registration status. Flag any manufacturers without SRNs.	Supply Chain/RA
Week 5–6 (May 6–19)	Build EUDAMED verification into receiving inspection procedures. Train warehouse and logistics teams.	QA/Operations
Week 7 (May 20–27)	Final confirmation: all key manufacturers are registered. Update import SOPs with EUDAMED verification step.	QA Director

Role 4: Distributors

What Distributors Must Register and When

Obligation	Module	Deadline	Key Data Required
Actor Registration	Actors	Distributors are NOT required to register as EUDAMED actors	N/A
Verify device compliance	Internal	Ongoing — per MDR Article 14	Verify device has CE mark, IFU available, UDI present, importer identified

The Distributor's Position in EUDAMED

Distributors have the lightest EUDAMED obligations of the four economic operator types. Under MDR Article 14, distributors must verify:

• The device bears the required CE marking
• The EU Declaration of Conformity and IFU are available
• The device has UDI assigned
• The device is accompanied by information required by MDR
• The importer and manufacturer are identified on the device or its packaging

Distributors do not need to register in EUDAMED's Actor module, obtain an SRN, or upload any device data. However, they must ensure that their suppliers (importers and manufacturers) are EUDAMED-compliant, as they cannot legally sell non-compliant devices.

Distributor Countdown Checklist

Week	Action Items	Owner
Week 1–2	Contact suppliers and verify their EUDAMED registration plans. Request confirmation of SRN status.	Procurement
Week 3–4	Update supply agreements to require EUDAMED compliance from manufacturers and importers.	Legal/Procurement
Week 5–6	Build EUDAMED compliance check into inventory receiving process. Train sales team on new verification requirements.	QA/Sales
Week 7	Confirm all key suppliers are ready for Day Zero. Prepare contingency for any supplier gaps.	Operations Director

Penalty Matrix: Member State Enforcement After Day Zero

Enforcement of EUDAMED obligations falls to individual EU member states' Competent Authorities. The MDR does not prescribe uniform EU-wide penalties — each member state sets its own enforcement framework. Below is a summary of enforcement mechanisms by major market based on published regulatory guidance and national implementing legislation.

Member State	Competent Authority	Enforcement Mechanisms	Key Penalties
Germany	BfArM / Paul-Ehrlich-Institut (PEI)	Market surveillance actions, product withdrawal, establishment inspections	Devices without EUDAMED registration can be prohibited from market placement. BfArM can issue non-compliance notices requiring immediate corrective action. Fines under the German Medical Device Implementation Act (MPDG) up to €50,000 for administrative violations. Criminal penalties for intentional non-compliance.
France	ANSM	Product suspension, market withdrawal, import bans, establishment inspections	ANSM can suspend marketing of non-compliant devices. Financial penalties under the French Public Health Code. ANSM can order recall of devices without valid EUDAMED registration. Potential criminal liability for responsible individuals.
Italy	Ministry of Health / Regions	Product seizure, market withdrawal, distribution bans	Italian implementing legislation provides for administrative sanctions. Devices without proper registration can be seized by health authorities. Fines proportional to the commercial value of non-compliant products.
Spain	AEMPS	Market withdrawal, import restrictions, establishment sanctions	AEMPS can prohibit continued marketing of non-registered devices. Administrative fines under Spanish pharmaceutical legislation. Suspension of distribution authorization for repeat offenders.
Netherlands	CIBG / IGJ	Market surveillance actions, product withdrawal, enforcement orders	Dutch Health and Youth Care Inspectorate (IGJ) can issue binding instructions to comply. Devices found non-compliant can be withdrawn from the Dutch market. Administrative fines up to €870,000 (or 10% of annual revenue, whichever is higher) under the Dutch Medical Devices Act.
Belgium	FAMHP	Product withdrawal, import prohibition, establishment sanctions	FAMHP has published detailed guidance on EUDAMED obligations. Non-compliant devices face market withdrawal. Administrative penalties and potential product seizure.

Common Enforcement Actions Across All Member States

Regardless of the specific member state, the following enforcement actions are universally available to Competent Authorities under MDR:

1. Market access restriction — Competent authorities can prohibit placement of non-compliant devices on the EU market through enforcement actions and sales suspensions.
2. Certificate processing delays — Notified bodies may refuse new certificate applications or renewals for manufacturers without completed actor registrations.
3. Increased regulatory scrutiny — Non-compliant manufacturers face heightened oversight, more frequent inspections, and stricter review of future submissions.
4. Supply chain disruption — Distributors and importers require proof of EUDAMED compliance, creating operational bottlenecks when registration requirements are not met.

National Registry Transition Status

Several member states operated national device registration databases before EUDAMED. The transition from national systems to EUDAMED varies by country:

Country	National System	Transition Status
Germany	DMIDS (Deutsches Medizinprodukte-Informations- und Datenbanksystem)	BfArM has confirmed that DMIDS remains mandatory until May 28, 2026. After Day Zero, EUDAMED replaces DMIDS for actor and device registration.
France	FSVI / ANSM portal	ANSM guidance indicates parallel operation during transition period. National requirements for clinical investigation notifications remain until EUDAMED Clinical Investigations module goes live.
Italy	Repertorio dei Dispositivi Medici	Ministry of Health is transitioning. National requirements for certain device categories may continue alongside EUDAMED.
Belgium	FAMHP platform	FAMHP published detailed transition guidance. Belgian operators should register in both national system and EUDAMED during transition.

Key point: National registration obligations remain in force until EUDAMED fully replaces them. Do NOT stop complying with national registration requirements during the transition period.

Swissdamed: Switzerland's Parallel System

Medical device companies operating in Switzerland must be aware of a separate, parallel registration requirement:

• SWISSMEDIC's Swissdamed system becomes mandatory on July 1, 2026, with a transition period until December 31, 2026.
• Swissdamed registration is separate from EUDAMED — a CH REP (Swiss Authorized Representative) is required.
• Companies selling in both EU and Switzerland must maintain compliance with both systems simultaneously.

What About Legacy and Directive Devices?

Legacy devices — those CE marked under the old MDD/AIMDD but still legally placed on the market during the MDR transition period — must also be registered in EUDAMED:

• Legacy devices must be registered by November 27, 2026.
• The manufacturer and EC REP for legacy devices must be registered in the Actor module.
• Legacy certificates must be uploaded by Notified Bodies by May 28, 2027 (18 months from the Commission Decision, covering both medical device and IVD certificates).

Practical Tips for the Final 50 Days

1. Prioritize Actor Registration first. Without SRNs, nothing else can proceed. Register your EC REP and then your manufacturing entity immediately.
2. Start with your top-selling devices. If you have a large portfolio, register your highest-revenue or highest-risk devices first. Work through the portfolio systematically.
3. Data quality is critical. EUDAMED has over 120 fields per device entry. Incomplete or inconsistent data will cause validation failures. Invest time in data cleansing before entry. For organizations with large device portfolios, consolidating these fields requires a level of data cleansing that most internal IT departments are not prepared to execute alone. Plan for data validation as a dedicated workstream, not an afterthought.
4. Marketing claims must match EUDAMED entries. The public-facing EUDAMED database will display device descriptions, intended purposes, and warnings. If your marketing materials conflict with your EUDAMED data, you face misbranding risk. Cross-reference marketing claims against EUDAMED entries before final submission.
5. Build EUDAMED into your product launch process. After May 28, 2026, EUDAMED registration is a prerequisite for market placement. Add it to your regulatory approval checklist.
6. Budget for ongoing maintenance. EUDAMED is not a one-time registration. Device updates, new variants, certificate renewals, and corrections all require ongoing data management.
7. Prepare for SRN issuance bottlenecks. National Competent Authorities validate Actor Registration submissions. A surge in registrations before Day Zero may create backlogs. Delayed SRN issuance blocks device registration and market access. Non-EU manufacturers need verification from their EC REP before the CA processes the application — ensure this digital linkage is active.

Key References

• Commission Decision (EU) 2025/2371 — Notice regarding functionality of EUDAMED modules (November 27, 2025)
• Regulation (EU) 2024/1860 — Transitional provisions for EUDAMED gradual roll-out
• Regulation (EU) 2017/745 (MDR) — Articles 27–34 (UDI), Article 92 (EUDAMED), Articles 123–125 (Transitional provisions)
• Regulation (EU) 2017/746 (IVDR) — Articles 24–27 (UDI), Article 101 (EUDAMED), Articles 110–113 (Transitional provisions)
• MDCG guidance documents on EUDAMED actor registration and UDI/Device module
• BfArM — Registrierung von Medizinprodukten: Übergang von DMIDS zu EUDAMED
• FAMHP — EUDAMED: details of obligations from 28 May 2026
• European Commission Q&A on practical aspects related to the gradual roll-out of EUDAMED