Eu IVDR Compliance Registration Service For Medical Device

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

An EU IVDR registration service is an execution assignment, not a standalone marketing authorisation. For an in vitro diagnostic medical device (IVD), the filing normally involves registering the legal actors, the device identifiers and data, and—where applicable—coordinating the notified body’s separate certificate entry. The manufacturer remains responsible for the truth of its filings.

As of 28 May 2026, EUDAMED’s Actor, UDI/Device, Notified Bodies & Certificates, and Market Surveillance modules are mandatory for the relevant users. The last module is operated by authorities, not a manufacturer application portal. Registration is not a substitute for conformity assessment, CE marking or performance-study authorisation.

Confirm that the IVDR filing route applies

Determine the intended purpose and market status before opening a filing. The product name “medical device” alone does not establish that IVDR applies.

Product situation	Registration decision
IVDR-compliant IVD placed on the EU market	Confirm IVDR scope and class, conformity route, manufacturer/representative roles and UDI. Prepare the Actor and UDI/Device records.
IVDD legacy IVD still placed on the market under a valid transition	Verify Article 110 transition eligibility and continued placements. Use the legacy-device route, not a fictitious IVDR certificate or automatically a new Basic UDI-DI.
Non-IVD medical device or wearable with no in-vitro diagnostic intended purpose	Do not file it as IVDR merely because it is medical. Assess the MDR/product route instead.
Research-use-only article with no IVD intended purpose, or device solely for a performance study	Check the actual intended purpose and the applicable exclusion/special procedure. A routine commercial UDI/Device entry may be inappropriate.

IVDR classification, conformity assessment and general product-law scoping require their own analysis; this page concerns execution once the route is established.

Who files which EUDAMED record?

There is no single “EU IVDR registration certificate” issued by EUDAMED. Map each required entry to the organisation legally responsible for it.

Record / filing	Responsible actor	Authority or system response
Actor / SRN	Manufacturer, EU authorised representative (where required), and importer each register under their respective roles; a service provider can prepare data and request access.	The relevant national competent authority validates the Actor request and issues the SRN via EUDAMED.
UDI/Device	Manufacturer submits the device-level registration; its UDI-DI, Basic UDI-DI (for regulation devices), intended purpose, EMDN and Annex VI data must match the controlled product records.	EUDAMED records the submitted data; this is not a regulatory approval of performance or safety.
Notified-body certificate	Where an IVDR notified body is required, the manufacturer supplies correct references and the notified body enters and updates its own certificate record.	Certificate content/status is maintained by the notified body; a consultancy cannot issue or upload it in the body’s place.
Importer checks / remaining modules	Importer checks required entries and adds its details. National processes still matter where applicable for vigilance and performance studies while their EUDAMED modules are not mandatory.	Market Surveillance is used by competent authorities; national obligations must be checked separately.

A distributor acting solely as a distributor is not required to obtain an Article 28 EUDAMED SRN for that role. Article 27(2) permits national distributor-registration requirements; first confirm that the business is not actually acting as an importer or manufacturer.

Prepare the registration data pack

Build one controlled source-of-truth spreadsheet or dossier index before data entry. These are practical preparation inputs; they are not a claim that the entire technical file must be uploaded to the UDI module.

Actor identity: Legal name, registered address, role, national authority, authorised users and signed EUDAMED information-security declaration.
Non-EU mandate: Signed written EU authorised-representative mandate and the mandate summary required for non-EU manufacturer Actor registration; confirm the representative’s active registration.
Regulatory status: IVDR or verified IVDD legacy basis, intended purpose, Annex VIII risk class, relevant dates and evidence supporting the selected route.
Device master data: Basic UDI-DI and associated UDI-DI(s) for IVDR regulation devices; corresponding EUDAMED identifiers for legacy devices; issuing-entity identifiers, EMDN, names and variants.
Evidence reconciliation: EU declaration of conformity, applicable notified-body certificate and its scope, labels/IFU, and Annex II/III technical-document references. Keep the underlying evidence under manufacturer control.
Public/linked information: For class C or D IVDR devices, identify the summary of safety and performance and notified-body validation/upload responsibility; cross-check public-facing identifiers.
Submission governance: Approved field owner, evidence version, role-based access, submission log, export/confirmation screenshots and a named owner for updates.

Where Article 26(2) IVDR applies to an assessment involving a notified body, assign the Basic UDI-DI before submitting the conformity-assessment application. Assigning that identifier is a separate milestone from completing the EUDAMED UDI/Device entry.

Submission sequence: from actor request to verified device record

Use a staged release rather than submitting unverified fields in parallel.

Lock classification and record owner. Sign off whether each identifier relates to a regulation IVD or a legacy IVD. Record the manufacturer and relevant EU representative/importer.
Register actors. Create EU Login access, submit each required Actor request with signed security declaration; for a non-EU manufacturer include mandate summary and follow the authorised-representative verification step.
Obtain validated SRN and access. Track national competent authority validation, respond to requests for correction, and approve organisational user access. An application receipt is not an issued SRN.
Prepare and submit device data. Use the manufacturer’s actor profile, register the Basic UDI-DI with linked UDI-DI(s) or the correct legacy identifiers, complete IVDR Annex VI fields and EMDN, and check the published record.
Reconcile certificate linkage. If a notified body is involved, verify that its certificate record can match the manufacturer, applicable representative and device identifiers; follow up with the body for its own upload.
Close and hand over the filing. Preserve submitted values, timestamps, supporting documents, open authority questions and a maintenance owner; ask the importer to conduct its statutory verification.

Registration deadlines and legacy-device gate

The operative date depends on the first individual unit under the relevant device identifier and whether the device is genuinely covered by transitional provisions.

Situation	Working filing gate
Relevant economic operator placing IVDs on the market from 28 May 2026	Actor registration/SRN must be in place as required by Article 28 IVDR; where a notified body is needed, register the actor before the notified-body application.
First unit of an IVDR-compliant device identifier placed on the EU market on/after 28 May 2026	Register the regulation device in UDI/Device before that first placement.
Same identifier first placed before 28 May 2026; more units placed after	The transition permits UDI/Device registration within 12 months of the 27 November 2025 notice (Commission timeline: 28 November 2026). Confirm the actual last submission day with the relevant authority and do not plan for the final day.
Sales ended before 28 May 2026 / qualifying legacy-to-regulation match	A routine UDI/Device record may not be required; the Commission Q&A identifies exceptions, including later vigilance actions and legacy records that are not the same device.
IVDR certificate issued before 28 May 2026 and related to a regulation device that is, or must be, registered	The notified body—not the manufacturer or filing agent—has the 18-month transitional registration period (Commission timeline: 28 May 2027). The Q&A limits this catch-up to the latest certificate version and, where applicable, latest related decision. New certificates and decisions after 28 May 2026 follow the mandatory-module rules. Some national notices specify 27 May 2027; confirm the authority’s operational cut-off and do not wait for the final day.

For the legacy-to-regulation “same device” exception, compare documented characteristics and identification, not appearance alone. The Commission Q&A cites matching identifiers such as UDI-DI (if assigned), catalogue/reference number or trade name reflecting shared characteristics. A change that would require a new UDI-DI for the regulation device defeats the same-device exception. Retain the comparison evidence and assess any later legacy-specific vigilance action separately.

A class-based IVDR transition deadline is not the same as a device-registration deadline. Neither makes an ineligible legacy device compliant. National distributor registration and other national requirements may remain relevant.

If no more units are placed on the market after 28 May 2026, routine Actor and UDI/Device entries may not be needed; a later reportable post-market-surveillance/vigilance action can trigger registration. For continuing eligible IVDD legacy devices, apply the 12-month identifier rule where its conditions are met; do not automatically apply the new IVDR-device first-placement rule to every legacy case.

Filing blockers: evidence, identifiers and authority queries

Treat the following as pre-submission QA flags, not as a claim that every authority applies the same automatic rejection code.

Failure mode	Corrective action before release
Manufacturer, importer and representative conflated into one Actor role	Validate each legal entity and role; request the relevant SRN separately.
Non-EU manufacturer lacks an accepted EU representative mandate	Resolve representative appointment and the required mandate summary before Actor submission.
IVDR regulation record created for an IVDD legacy product	Reassess transition status and choose the legacy identifier/data set where legally appropriate.
Basic UDI-DI, UDI-DI, trade name, EMDN or class mismatches	Reconcile the controlled identifier table, labels, declaration and certificates before sending data.
Certificate cannot be linked or has the wrong notified-body scope	Contact the actual notified body; resolve manufacturer/Basic UDI-DI references and the certification status.
Actor request or later amendment awaits competent-authority verification	Track the authority query, retain correspondence and do not describe the pending entry as validated.
A correctly submitted device entry is not yet visible to the public	For certain devices EUDAMED publication depends on the notified body registering the linked product certificate. Inspect the submitted record and certificate status before treating non-visibility as a rejected filing.

Maintain IVDR actor, device and certificate registrations

Registration is a maintained record, not a one-off approval. Use an event-trigger register for legal, product and supply-chain changes.

Actor changes: Update the Article 28 information within one week of a change; confirm accuracy within one year of submission and every second year thereafter.
Device data: Keep Article 26/Annex VI fields accurate, assess when a change needs a new UDI-DI and reconcile labels, declarations and certificates.
Importer duties: Check the manufacturer’s/representative’s actor information within two weeks of placement under Article 27(3), verify device registration under Article 13 and add importer information to the relevant entries.
Certificates and incidents: Coordinate certificate changes with the notified body. Follow the applicable national vigilance/performance-study channels until their EUDAMED modules become mandatory; do not assume the Market Surveillance module is a manufacturer submission portal.

Deliverables of an IVDR actor and device registration engagement

A filing-execution engagement should identify the legal applicant and precisely what is being prepared and handed over. Typical deliverables are:

Registration route sheet: Evidence-based IVDR/legacy gate, actor map, first-placement dates and list of dependencies.
Submission-ready data pack: Annex VI field mapping, Basic UDI-DI/UDI-DI or legacy crosswalk, EMDN and inconsistency log.
Filing support and query handling: Actor request coordination, controlled device entry, validation checks and a tracked list of unresolved authority/notified-body actions.
Handover and maintenance register: Submitted record identifiers, confirmation evidence, responsibility matrix and next change/confirmation triggers.

The client/manufacturer approves product claims and supplies authentic evidence. A provider does not replace the authorised representative, notified body or competent authority merely by assisting with filings. Scope, professional fees, any national charges and timing must be agreed after the product list, countries, roles and dossier status are reviewed. For wider compliance work see full IVDR compliance process; for the representative’s appointment and duties see EU authorised-representative obligations; for a non-IVD medical product route see MDR route for non-IVD devices.

Registration-specific questions

Can class A IVDs be registered without a notified-body certificate?

For an IVDR class A device other than one placed on the market in sterile condition, the usual conformity-assessment route does not require notified-body involvement. Class A sterile devices require notified-body involvement for sterility aspects. The appropriate EUDAMED registration still applies.

Can a US or other non-EU manufacturer obtain an SRN without an EU authorised representative?

No where Article 11 IVDR requires the non-EU manufacturer to designate an EU authorised representative. The manufacturer’s Actor request also requires a mandate summary; the representative’s involvement does not transfer the manufacturer’s device-data responsibility.

Can an importer submit the manufacturer’s UDI/Device record instead?

The IVDR assigns device registration to the manufacturer. The importer has its own registration and verification/add-details obligations; technical assistance or authorised access does not rewrite statutory responsibility.

Must every IVDD legacy IVD receive a second record once the IVDR version is registered?

Not necessarily. Commission guidance allows an exemption where the same device is already registered as a regulation device, but changed identifiers or an incident concerning the legacy version can alter the answer. Verify the actual identity and event.

Does an EUDAMED number authorise sale or a performance study?

No. An SRN identifies an actor, a UDI/Device record identifies device data, and a notified-body certificate is handled separately. Applicable conformity, CE-marking and performance-study requirements must be met independently.

Official regulatory sources

The IVDR is binding law; the Q&A hosted on the Commission website expressly states that it has not been formally endorsed and is non-binding explanatory material. Check current module guidance and national requirements before filing.