Eu Mdr Medical Device Compliance Registration Service

Scope and evidence must be confirmed before any paid tests or filings.

EU MDR medical-device registration is not one universal approval application. Execution usually involves an EUDAMED actor record, an MDR device/UDI record and, when the conformity route calls for it, a separate notified-body assessment and certificate entry. This service concerns assembling, filing, reconciling and maintaining those records—not selling an official EU authorisation.

As of 28 May 2026, EUDAMED Actor, UDI/Devices and Notified Bodies & Certificates modules are mandatory; Market Surveillance is also mandatory for authorities. The vigilance and clinical-investigation modules are not yet mandatory. Establish the device route and the responsible legal entities before opening any filing.

What registration proves—and what it cannot prove

EUDAMED registration records identify actors and devices; they do not replace conformity assessment, clinical evaluation, technical documentation, the EU declaration of conformity or CE marking. An SRN identifies an economic operator; it is not a licence, a device certificate or permission to market a non-compliant product.

This page covers MDR medical devices under Regulation (EU) 2017/745. In-vitro diagnostic devices follow Regulation (EU) 2017/746; custom-made and investigational devices have distinct rules. Confirm whether an item is a medical device and its risk class before choosing a submission path.

Who files each record: responsibility matrix

Separate the legal filer from the person typing in the database. Delegated account access does not transfer the underlying MDR responsibilities.

Responsible party	Filing / validation role
EU manufacturer	Requests its own actor registration/SRN; assigns Basic UDI-DI and UDI-DI, verifies product data and submits applicable device entries.
Non-EU manufacturer	Appoints an EU authorised representative first; the registered representative verifies the manufacturer actor request before competent-authority validation. The manufacturer remains responsible for its device data.
EU authorised representative	Registers its own actor role, verifies the non-EU manufacturer during onboarding and performs obligations under its written mandate; it is not automatically the device manufacturer or notified body.
Importer	Registers its importer actor role and checks/adds the applicable importer information in the device record; it does not replace manufacturer registration.
System/procedure-pack producer	For Article 22(1)–(3) packs, registers as a separate SPPP actor (Actor ID, not an Article 31 SRN) and submits the applicable pack record. Under Article 22(4), the responsible person instead assumes manufacturer obligations and the pack is registered as a device. Check the CE status of component devices, intended-purpose compatibility, the applicable Article 22 statement and, for sterile packs, evidence of the sterilisation route before filing.
Distributor acting only as distributor	No EUDAMED actor registration solely for distribution; an importer or manufacturer role changes the answer. Check separate national distributor rules.
Notified body / competent authority	The competent authority validates relevant actor requests and issues SRNs via EUDAMED; the notified body handles its certificates and required device-data confirmation where applicable. Neither is a commercial registration agent.

Filing dossier: evidence and data to collect

Before data entry, assemble one controlled filing dataset per legal entity and device family. A consultant can prepare and transmit approved data, but the manufacturer must own its accuracy.

Actor file: exact legal name, registered address, role, contacts, PRRC details where required, competent jurisdiction, signed EUDAMED information-security declaration and authorised user access.
Non-EU file: active EU authorised representative, written mandate, mandate-summary upload, representative SRN and matched legal names before the manufacturer submits its actor request.
Device identity: intended purpose, MDR class and rule, device name/model, Basic UDI-DI grouping, UDI-DIs, issuing entity, packaging hierarchy and EMDN code.
Conformity cross-check: applicable Article 52 route, notified-body certificate identifiers if relevant, EU declaration of conformity and matching labels/UDI and technical-document references. Full technical documentation is generally maintained as compliance evidence, not uploaded as one blanket EUDAMED approval dossier.
Data-sheet reconciliation: Annex VI Part A/B fields, risk class, actor SRNs, member-state availability data where applicable and any special device characteristics; check every field against controlled source documents.
Submission controls: EU Login, manufacturer-linked EUDAMED access, preparer/proposer and confirmer privileges, four-eyes approval, submission log, record IDs and a correction owner.

Submission mechanics: seven execution steps

Route check. Verify MDR rather than IVDR, intended purpose, classification, conformity route, custom-made or legacy status and whether national requirements need checking.
Actor onboarding. Register each relevant economic operator under its correct role; for non-EU manufacturers complete authorised-representative verification and authority validation to obtain an active SRN.
Enable user access. Assign EU Login users to the validated actor. A Proposer may prepare drafts; a Confirmer is needed to submit/confirm device entries.
Build device hierarchy. Allocate Basic UDI-DI, associate each UDI-DI and packaging configuration and select the EMDN term; verify identifiers against labelling and controlled master data.
Reconcile certificates. Where a notified body is required, align Basic UDI-DI, certification scope and actor IDs with the notified-body process. The notified body, not the consultant, registers its certificates.
Submit and validate. Enter the MDR device dataset in UDI/Devices, resolve system errors, confirm the submission, capture evidence of status and review any required notified-body confirmation.
Hand over. Deliver record identifiers, an export/checklist of accepted data, unresolved exceptions and ownership for later correction, renewal or change.

Do not apply the new MDR device identifier checklist unchanged to legacy MDD/AIMDD devices: the relevant EUDAMED DI and EUDAMED ID (or an existing UDI-DI, where applicable) replace the ordinary Basic UDI-DI/UDI-DI route. For systems and procedure packs under MDR Article 22, check the distinct system/procedure-pack producer and registration route. Custom-made devices are not entered as ordinary UDI/Device records; an Actor ID and limited data for relevant future reporting may still be required.

Which filing is due, and when?

Use the actual placing-on-the-market history—not only today’s product status—to determine the relevant registration deadline. Dates below address the MDR EUDAMED rollout, not notified-body certification deadlines.

Case	Who acts / requirement	Timing
New MDR device being placed on the market after module go-live	Manufacturer completes applicable actor and device registration before placing the device on the market; certificate route remains separate.	Since 28 May 2026
MDR device whose first unit was placed before 28 May 2026, with further units of the same UDI-DI placed afterward	Manufacturer enters required device data for devices covered by MDR Article 123(3)(e), as amended.	No later than 28 November 2026
Eligible legacy MDD/AIMDD device: first unit placed before 28 May 2026 and further units continue afterward	Manufacturer checks MDR Article 120 status and registers the relevant legacy-device data unless the corresponding MDR-assessed device is already registered.	No later than 28 November 2026, if Article 123(3)(e) conditions apply
Custom-made / investigational MDR device; or an IVD	Do not force the ordinary MDR regulation-device UDI workflow. Assess the applicable exception or IVDR process before filing.	Route-dependent; not a blanket MDR UDI/Device deadline
Device with no further units placed on the EU market after 28 May 2026	Ordinary UDI/Device backfill does not apply merely because units were sold earlier. Evaluate separate post-market surveillance/vigilance reporting triggers.	No routine 28 November 2026 device backfill if the condition is met
MDR/IVDR notified-body certificate issued before 28 May 2026	The notified body—not the manufacturer or filing consultant—checks whether the older Regulation certificate requires an EUDAMED entry; subsequent decisions after 28 May 2026 have separate entry duties.	Relevant older certificates: 28 May 2027 (conditional 18-month backfill)

A cessation of placements affects actor filings too: according to the Commission’s gradual-rollout Q&A, a manufacturer, its authorised representative, an importer or an SPPP placing no further units/packs on the market after 28 May 2026 need not register as an actor solely because of earlier placements. Reassess if a post-market surveillance/vigilance action arises. The EUDAMED vigilance module is not yet mandatory; required vigilance reports currently follow the applicable national channels rather than a routine UDI/Device registration.

The 28 November 2026 transition concerns qualifying existing and legacy device entries; it does not create a general right to put a new non-compliant device on the market without completing its mandatory pre-market steps. Separate catch-up rules govern older notified-body certificates.

For an MDR-compliant device first placed on the market before 28 May 2026, this catch-up date applies only where further units of the same device identifier continue to be placed on the market on or after that date. It is not a grace period for the first sale of a new device. The European Commission timeline shows 28 November 2026; as a prudent operational target, complete submissions by 27 November and check competent-authority instructions in the relevant Member State.

Five causes of rejection or delay

Stop point	Practical corrective action
Actor request does not validate	Reconcile legal registration data, role and competent authority; upload the signed security declaration. For a non-EU manufacturer, verify the active representative and mandate summary first.
The wrong person tries to submit	Check that the actor’s SRN is active and the user has the required Confirmer privileges, rather than only draft/Proposer access.
Basic UDI-DI conflicts with certificate or UDI-DI	Lock one device-identity master and compare EUDAMED fields with issuing-entity data, labels, declaration of conformity and notified-body records.
Wrong status or device family	Distinguish MDR regulation device, eligible legacy device, custom-made device and IVDR product; never invent an MDR certificate for a self-certified route.
Application submitted but record is not complete	Inspect the actual transaction/status and any required notified-body confirmation; archive the response and close corrections instead of equating draft creation with filing.

Maintaining registrations after filing

Registration is a continuing data-governance obligation, not a one-off receipt. The named economic operator retains the legal responsibility even when a service provider operates the interface.

Keep actor contact and role information accurate; verify and update the actor data as required by MDR Article 31, including its periodic accuracy checks.
Control changes to legal names, authorised representatives, importer links, device models, UDI identifiers, risk class and certificate status; test whether the change needs a correction, new record or regulatory review.
Keep manufacturer-held technical and clinical evidence, the conformity route, the declaration of conformity and post-market records up to date outside the registration screen.
Check applicable Member State notifications and national operational requirements separately; EUDAMED is not a promise that every local filing disappears.

For actor data, MDR Article 31(4) requires updates within one week of a change. Under Article 31(5), accuracy is to be confirmed no later than one year after initial submission and every second year thereafter. These are actor-record duties; do not confuse them with device-registration timing.

Service outputs, limits and the next action

A properly scoped registration execution engagement can produce auditable operational deliverables:

Actor and device filing matrix with nominated legal filer, authorised platform users, dependency gates and submission priority.
Field-level Annex VI/UDI data workbook mapped to source evidence; missing-data and classification exceptions listed before submission.
Actor and device submission support, status reconciliation, authority/representative/notified-body query tracker and submission proof.
Post-filing register with record owners, correction log, change triggers and periodic verification dates.

A filing service cannot issue an SRN itself, certify a device, grant a notified-body certificate, guarantee regulator acceptance or replace the manufacturer’s legal duties. For strategic classification and gap assessment, see MDR compliance advisory; for non-EU representation and mandates, see EU authorised-representative service. Country-specific execution is addressed separately for filing in Italy, filing in France and filing in Spain.

Start with the manufacturer’s jurisdiction, exact legal entities, intended purpose, MDR class, current conformity status, existing SRNs, list of Basic UDI-DIs/UDI-DIs and first/last placing-on-market dates. Without these facts, neither the submission path nor any transitional deadline can be confirmed.

Filing-specific questions

Does obtaining an SRN mean our medical device is authorised for sale?

No. The SRN identifies an operator. The manufacturer must still complete the applicable MDR conformity route, maintain required evidence, execute the EU declaration of conformity and apply CE marking when justified.

Can a US or UK manufacturer register without an EU authorised representative?

An MDR manufacturer established outside the EU needs an appropriately appointed EU authorised representative for this route. The representative must be registered to verify the non-EU manufacturer’s EUDAMED actor request before authority validation.

We already sell a device in the EU. Is 28 May 2026 or 28 November 2026 our deadline?

28 May 2026 is the start of mandatory module use. The Article 123(3)(e) catch-up obligation for qualifying existing/legacy device records runs to 28 November 2026. Verify market history, MDR/legacy status and any separate submission trigger before relying on this date.

Can we upload one PDF technical file instead of structuring Basic UDI-DI and UDI-DI entries?

No. The EUDAMED UDI/Devices module requires structured product data and identifiers under Annex VI; the manufacturer maintains broader technical documentation under the MDR. One generic PDF does not substitute for the device records.

Does every Class I device need a notified-body certificate for registration?

No. A manufacturer may self-assess ordinary Class I devices where the MDR permits it; a notified body is required for specified features or higher-risk routes. Classification and conformity assessment must be checked independently from EUDAMED data entry.

Who fixes incorrect information or a later change in the registered device?

The legally responsible operator must ensure information remains correct, using appropriately authorised users to amend records and coordinating with a notified body where its certificate information is affected. Keep an auditable correction log.