EUDAMED submissions – formal obligations

The EUDAMED system is the EU’s central IT platform for collecting, sharing and supervising data on medical devices and in-vitro diagnostics. It does not replace registration procedures as such – it is a structural element that must be synchronised with conformity assessment, the technical documentation file and CE marking.

A submission to EUDAMED includes information on the manufacturer, authorised representative, importer and the device itself. The platform is being rolled out in modules; the economic-operator, device and clinical-investigation modules are already live. Inactivity can block market access even when a valid CE certificate exists.

Even while some modules remain “voluntary”, several national authorities now require an EUDAMED entry before local notification. Integration with EUDAMED is therefore not only a legal obligation but an operational necessity that determines market availability.

Obligations before placing the product on the EU market

After completing the conformity assessment and affixing the CE mark, the manufacturer must still:

  • register all economic operators in EUDAMED,
  • enter product data in the device module (once fully operational),
  • prove that labels, IFU and translations comply with national rules,
  • identify the first country of placement, which drives distributor and importer notifications.

If the product is covered by a derogation, the national authority’s decision must be documented – failure to show that record may be challenged during inspection.

Registration via an EU authorised representative

For non-EU manufacturers the authorised representative (EC-REP) is responsible for submitting and maintaining all EUDAMED data. Any mismatch between label, CE certificate and EUDAMED entry can lead to suspension.

The EC-REP cannot be a mere “mailbox”: they must have access to the full technical file, understand the intended purpose and be able to present conformity-assessment and post-market surveillance data. The detailed duties are listed in the section on the authorised representative.

IVD registration specifics under the IVDR

The IVDR introduced a completely new registration landscape. Most IVDs now require a notified body, and analytical- / clinical-performance data obligations are far stricter.

Classes B, C and D must be filed by an EC-REP and, for class D, performance data are often sent to an EU reference laboratory. IFUs must appear in every language of the sales countries and must match the EUDAMED entry. An IVD is no longer a “lesser” device – under the IVDR its regulatory weight equals a class III medical device.

Linking registration to UDI and the identification system

Each device (MD or IVD) needs a unique UDI, which must be entered in EUDAMED and printed on the label. In the EU the UDI is both an identifier and a reporting tool that ties incidents, updates and changes to a specific product level.

The Basic UDI data used at registration must align with the certificate and technical file. More details are provided in UDI labelling.

Maintaining the registration status

EU registration is not a one-off event. Any significant change – for example a new contract manufacturer, updated IFU or a design change – has to be logged in EUDAMED. The manufacturer or EC-REP must update records within the prescribed window (usually 7–15 working days).

All EUDAMED data must match the information provided to distributors and importers; otherwise products can be blocked even when the CE certificate is still valid. Constant communication between RA, sales and distribution teams is essential – registration is a live process, not a static document.

How Pure Clinical supports EU MD & IVD registration

Successful EU registration demands insight into MDR/IVDR, national practices and the real-world status of systems such as EUDAMED. Pure Clinical guides manufacturers and representatives through preparation, submission and maintenance.

We assist with:

  • creating EUDAMED submissions – economic operators and devices alike,
  • cross-checking data against certificates and technical documentation,
  • co-ordinating filings via the EU authorised representative,
  • maintaining registration status – updates, significant changes, re-registrations,
  • integrating UDI data with labelling and documentation systems,
  • pre-registration actions, including the pre-registration audit.

Our experience spans all EU markets and all risk classes, from class I devices to class D IVDs.

FAQ

Can a product be sold in the EU without an active EUDAMED entry if it holds a CE certificate?

Formally yes, if the module isn’t yet mandatory. However, many EU countries (e.g., France, Spain) treat the absence of an EUDAMED record as a market barrier. Distributors may refuse to carry the product, and national inspectors may challenge its legal status if no system entry is available.

What risks do manufacturers face if EUDAMED data differs from label information?

Inconsistencies may lead to registration suspension and halted sales. Notified bodies and national authorities increasingly cross-check UDI, IFU, and certificates against EUDAMED entries. Discrepancies are treated as non-compliance with MDR/IVDR and may trigger corrective actions or penalties.

Can a manufacturer change its authorized representative without losing registration continuity in EUDAMED?

Yes, but the transition must be carefully managed. A formal transfer of responsibility between the old and new EC-REP is required, including timely updates in EUDAMED. If not synchronized, a registration gap may occur, disrupting market access and vigilance reporting.

Is the manufacturer liable for incorrect EUDAMED entries made by their EC-REP?

Yes – while the authorized representative handles the submission, the manufacturer remains responsible for data accuracy. Errors (e.g., in UDI codes or product descriptions) may result in entry rejection or compliance issues during audits or regulatory inspections.