EUDAMED 2026 – legacy products, UDI & registration 28 November | Word/PDF/Excel

Does your medical device company have models that were already on the EU market before 28 May 2026 – and are you continuing to place new specimens on the market? If so, registration in EUDAMED’s UDI/Device module may need to be completed by 28 November 2026 at the latest. This Swedish specialist package helps manufacturers, importers, and authorised representatives document the correct actor role, identify affected product models, manage legacy IDs, and verify actual registration receipts.

Legal scope: The specific deadline of 28 November does not apply to all products. Models that are placed on the EU market for the first time from 28 May 2026 onwards must normally be registered before being placed on the market. Models that were placed on the market earlier and continue to be placed on the market may be subject to the 28 November deadline. Certain old devices, in-house products, study products, products equivalent to already registered MDR/IVDR products, and specific master UDI categories must be assessed separately. Current guidance from the Swedish Medical Products Agency.

Five operational templates – from the correct role to receipt

1. A01 – Actor role assessment and 28 November: identify which company must register what; distinguish between manufacturers, importers, authorised representatives, healthcare set assemblers, and standard distributors. Document the product model, MDR/IVDR, actual first EU market release, and continued release of new specimens.
2. A02 – Actor registration, SRN, and PRRC: collect actual company details, contact information, the person responsible for regulatory compliance, and the authorised user. Separate multiple actor roles and archive actually assigned SRNs. A standard distributor must not be incorrectly classified as a registration-obliged actor.
3. A03 – Legacy product identifier: check whether the legacy product already has a UDI-DI; document the correct EUDAMED DI and, where applicable, EUDAMED ID. Codes must come from actually assigned data and the EUDAMED procedure, not improvised template values.
4. A04 – UDI, EMDN, CE, and receipt: match the manufacturer/SRN, Basic UDI-DI, UDI-DI, EMDN code, relevant CE basis, and certificate from the notified body. Distinguish between submitted registration documentation and an actually confirmed registration entry.
5. A05 – Gaps, actions, and final sign-off: capture missing receipts, incorrect model classification, or identifiers, and document the responsible person, final internal check, any manual hold on continued market release, and signed decision.

Excel register with nine tabs

Overview, Actors, Products, Legacy IDs, Deadlines, Chain of Evidence, Non-conformances, Decisions, and Sources. The workbook uses formulas to summarise actual product models and flag, among others, MISSING REGISTRATION RECEIPT, MISSING ACTOR/CE EVIDENCE, MISSING ROLE/DATE, and MISSING SIGNATURE. A registered ID or a signed internal check is never automatically counted as EUDAMED approval.

Example decision: An MDR product model that was first placed on the market in March 2026 and whose new specimens continue to be placed on the market after 28 May may have a control deadline of 28 November 2026. A new model that is not due to be placed on the market until December 2026 must normally be registered before its first release. An old model whose specimens are no longer being placed on the market receives a separate exemption assessment. Excel does not make the legal decision.

What applies in EUDAMED from May and November 2026?

The European Commission explains that four modules became mandatory on 28 May 2026: actor registration, UDI/product, notified bodies and certificates, and market surveillance. The background is MDR (EU) 2017/745, IVDR (EU) 2017/746, amending Regulation (EU) 2024/1860, and the Commission’s publication (EU) 2025/2371. The modules for safety monitoring/vigilance and clinical investigations are not yet mandatory on the same basis and have a separate timeline.

According to the European Commission’s guidance on product registration, the manufacturer must register the product. Importers and authorised representatives normally need to register their actor roles; this does not mean that every importer must register the manufacturer’s products under their own name. A pure distributor should normally not be registered as an actor. An SRN is an actual register ID, not a value that can be generated in Excel.

Legacy, old devices, and special identifiers

A legacy product is not the same as an old device. For a relevant legacy product, EUDAMED DI and EUDAMED ID may be required even if a Basic UDI-DI is not mandatory for this product under the new rules. If a UDI-DI has already been assigned, the EUDAMED DI can be created from this; otherwise, the system’s specific procedure applies. Official Legacy Device User Guide.

Special cases: The Swedish Medical Products Agency states that contact lenses with a master UDI-DI must be registered by 28 November 2026 at the latest, while certain eyeglass lenses, eyeglass frames, and reading glasses are subject to a special later deadline of 1 November 2028. This register is a control template and does not replace product classification, the CE process, or official registration.

Who is the package for?

Swedish medical device manufacturers, IVD manufacturers, smaller importers, authorised representatives, healthcare set assemblers, and companies with remaining products under older directive certificates. Particularly useful for QA/RA managers who need to clear a registration backlog before 28 November.

Frequently asked questions

Must all medical devices be registered by 28 November 2026 at the latest?

No. The deadline primarily applies to certain models already placed on the market that are still to be placed on the market in new specimens. For models that start being placed on the market after 28 May 2026, registration before the first market release normally applies.

Must a standard distributor obtain an SRN?

Not solely because it distributes products. However, an importer, manufacturer, or authorised representative may be subject to actor registration. Actual roles and multiple business activities must be assessed separately.

What is the difference between UDI-DI and EUDAMED ID for legacy products?

A UDI-DI is an actual product identifier from the applicable identification system. EUDAMED ID is used for legacy products when a UDI-DI is not available and is generated according to EUDAMED’s system. The template does not issue new identities.

Can we mark it as “complete” once the information has been submitted?

Not without verification. Excel distinguishes between internal documentation, the actual registration reference, and the authorised manual final sign-off. The receipt must be checked in the actual EU portal.

Are completed certificates, SRNs, and regulatory approvals included?

No. The package includes blank work templates and administrative registration checks, not CE certificates, medical device product approvals, or regulatory submissions.

What formats and languages are delivered?

Five Swedish work templates, one Swedish guide, and a separate English User Guide. All seven are in Word and searchable PDF, plus a Swedish Excel workbook with nine tabs. The PDFs are not interactive fillable forms.

Legal sources, version, and limitations

Version 1.0. AI-assisted internal legal source check 10 November 2026. Primary sources: European Commission: EUDAMED, Swedish Medical Products Agency, MDR/IVDR, and the EU regulations mentioned above. Check for subsequent regulatory updates and the product’s actual application.

No external independent legal review, regulatory specialist certification, CE assessment, EUDAMED submission, SRN, or UDI generation has been performed. The documents are work aids, not official EU forms or a guarantee of lawful sale. The digital ZIP file is not linked to Digital Products until the store owner separately decides to activate it.