The EUDAMED and UDI compliance checklist for a startup has eight stages, in this order: (1) actor registration and Single Registration Number (SRN) under MDR Article 31, (2) Basic UDI-DI selection and grouping under Article 27, (3) UDI-DI assignment through a designated issuing entity, (4) UDI-PI generation tied to your production records, (5) device registration in EUDAMED with the Annex VI Part A Section 2 and Part B data, (6) application of the UDI carrier on the label and packaging under Article 27(4), (7) record-keeping of UDIs under Article 27(9), and (8) sequencing all of this to complete before you place the device on the market. Every step traces to a specific MDR article and to Commission Implementing Regulation (EU) 2021/2078.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • Actor registration comes first: no SRN, no device registration, no legal placing on the market for a manufacturer, authorised representative, or importer under MDR Article 31.
  • Basic UDI-DI groups devices that share the same intended purpose, risk class, and essential design — it is the identifier used in EUDAMED, on your certificate, and in your technical documentation.
  • UDI-DI and UDI-PI come from a UDI issuing entity designated by the Commission; the choice of issuing entity is a commercial decision with permanent consequences.
  • Device registration in EUDAMED requires the full Annex VI Part A Section 2 and Part B data, submitted before first placement on the market and kept up to date thereafter.
  • The UDI carrier has to appear on the label, the packaging, and (for reusable devices under Article 27(4)) the device itself, using the AIDC and HRI format specified by the issuing entity.

The checklist exists because the order matters

Founders tend to discover EUDAMED and UDI the same way. Two months before planned launch, the Notified Body auditor asks for the SRN. The founder opens the EUDAMED information page, sees five buttons, does not know which one to click, realises the Basic UDI-DI they printed on the carton eight months ago may be grouped wrong, and asks whether any of this can be fixed in the afternoon before the audit closes. It usually cannot — not cleanly. The issuing entity contract takes weeks. The Competent Authority verification of actor data takes its own time. Labels that already carry a UDI carrier cannot be silently rewritten without a change record. The order of operations is what makes EUDAMED and UDI expensive when it is done late and cheap when it is done early.

This checklist is written for a small manufacturer who wants to do the work once, in the right sequence, without paying consultants to draw the same diagram twice. Every step is tied to a specific MDR article. Every step is something a founder can do themselves with a regulatory affairs colleague, a competent PRRC, and a few afternoons. The companion pillar for the whole cluster is What is EUDAMED?. Use this checklist alongside it.

Stage 1: Actor registration and the SRN

The first touchpoint is actor registration under MDR Article 31. Before you can place any device on the market, you must submit the economic operator information listed in Annex VI Part A Section 1 to the EUDAMED actor registration module. The Competent Authority of the Member State where your manufacturer, authorised representative, or importer is established verifies the submission. EUDAMED then issues the Single Registration Number.

Checklist items for Stage 1:

  • Confirm which entity is the "manufacturer" under MDR Article 2(30). Only one entity holds that role per device.
  • If your manufacturer is established outside the EU, appoint an authorised representative under Article 11 before attempting actor registration — the AR registers on behalf of the non-EU manufacturer.
  • Gather the Annex VI Part A Section 1 data: type of economic operator, legal name, trading name, address, contact details, VAT number where applicable, the data identifying the natural person responsible for submitting the information, and the details of the Person Responsible for Regulatory Compliance (PRRC) under Article 15.
  • Prepare a declaration on the accuracy of the data, which the Competent Authority will require before verification.
  • Identify the competent authority of your Member State that handles MDR actor registration verification. This is not always the same authority that handles clinical investigations.
  • Submit the actor registration request through the EUDAMED actor module.
  • Receive the SRN. Store it in a single place that your team can find in thirty seconds. It will be quoted in every future EUDAMED interaction, every Notified Body submission, and every Competent Authority correspondence.
  • Update the SRN across internal systems: QMS records, tech file cover pages, Notified Body portal, label master documents.

The SRN is permanent. A single company has exactly one SRN per role (one as manufacturer, one as AR, and so on). Treat it with the seriousness you would treat a VAT number. For the deep dive see what is the Single Registration Number (SRN) and how to register your startup as a manufacturer in EUDAMED.

Stage 2: Basic UDI-DI selection and grouping

The Basic UDI-DI is defined in MDR Article 27(6) and Annex VI Part C. It is the main key that identifies a device or group of devices for regulatory purposes. Grouping is the decision that founders underestimate. One Basic UDI-DI per device family sounds simple until you look at the criteria: devices grouped under one Basic UDI-DI must share the same intended purpose, the same risk class, the same essential design and manufacturing characteristics, and the same name and trade name. Diverge on any of these and you need a new Basic UDI-DI.

Checklist items for Stage 2:

  • List every device model, variant, accessory, and package configuration you intend to place on the market.
  • For each, document the intended purpose, risk class (under Annex VIII), essential design characteristics, and manufacturing process.
  • Cluster the list by items that share all four criteria. Each cluster is one Basic UDI-DI.
  • Verify that accessories with their own intended medical purpose are treated as devices in their own right and get their own Basic UDI-DI.
  • Confirm that configurations which differ only in packaging or labelling still share a Basic UDI-DI, while configurations that differ in essential design do not.
  • Record the Basic UDI-DI grouping decision in your technical documentation. The same Basic UDI-DI must appear on the EU Declaration of Conformity, in the technical file, on the Notified Body certificate (where applicable), in the clinical evaluation, and in EUDAMED.
  • If you discover mid-way through certification that the grouping is wrong, fix it before the certificate is issued. Changing a Basic UDI-DI after issuance is a change record every auditor will look at.

For the full concept explanation see what is a Basic UDI-DI.

Stage 3: UDI-DI assignment through an issuing entity

The UDI-DI is defined in Article 27(1)(a). It is the numeric or alphanumeric code that uniquely identifies a device model. The Commission designates issuing entities under Article 27(2); at the time of writing these include GS1, HIBCC, ICCBBA, and IFA. Your UDI-DI must come from one of these entities.

Checklist items for Stage 3:

  • Choose an issuing entity. The decision is commercial and operational: different entities have different fee structures, different existing adoption in your target markets, and different tooling. Once chosen, it is effectively permanent for a product line.
  • Set up the contractual relationship with the chosen issuing entity. Allow weeks, not days.
  • Assign a UDI-DI to each device variant that needs one. A new UDI-DI is required whenever a change to the device affects identification under the rules of the issuing entity.
  • Record every UDI-DI against the corresponding Basic UDI-DI in your internal master data.
  • Confirm that your UDI-DI assignment rule is documented in the QMS. Auditors want to see the procedure, not just the output.

Stage 4: UDI-PI generation

The UDI-PI is the production identifier defined in Article 27(1)(b). It identifies the unit of device production — lot number, serial number, manufacturing date, expiry date, or software version as applicable. Unlike the UDI-DI, the UDI-PI changes with every production lot.

Checklist items for Stage 4:

  • Decide which PI elements apply to your device: lot, serial, manufacturing date, expiry date, software version. The choice depends on device type and is often dictated by risk class and traceability needs.
  • Connect the UDI-PI generation to your production records and device history record so that every physical unit can be traced back to batch-level manufacturing data.
  • For software as a medical device, tie the UDI-PI to the software version control system so each released version carries the correct PI.
  • Confirm that your labelling system can print or encode the UDI-PI alongside the UDI-DI on every unit, package, and higher-level carton.

Stage 5: Device registration in EUDAMED

Device registration under MDR Article 29 requires the manufacturer, before placing a device other than a custom-made device on the market, to assign a Basic UDI-DI and to submit the Basic UDI-DI together with the information referred to in Annex VI Part A Section 2 to EUDAMED. The data must be kept current.

Checklist items for Stage 5:

  • Confirm the device is not in scope of the custom-made device exemption under Article 29(2).
  • Assemble the Annex VI Part A Section 2 data: Basic UDI-DI, device name, risk class, type of device (implantable, reusable, software, etc.), the presence of substances of specific concern, the presence of CMR or endocrine-disrupting substances above thresholds, and the other data elements listed in Annex VI.
  • Assemble the Annex VI Part B data that applies to UDI-DI level: quantity per package, clinical size, critical warnings, URL for additional information, and the other Part B elements.
  • For implantable and Class III devices (other than custom-made or investigational), prepare the Summary of Safety and Clinical Performance under Article 32 — it is published through EUDAMED after Notified Body validation.
  • Submit the registration in the EUDAMED UDI and device registration module.
  • Establish a recurring review cadence to keep the Annex VI data current. Every change to the device that affects any registered data point triggers a EUDAMED update.

For the workflow in detail see device registration in EUDAMED.

Stage 6: UDI carrier on the label and packaging

Article 27(4) requires the UDI carrier — the representation of the UDI in AIDC (Automatic Identification and Data Capture) format and, where space allows, in HRI (Human Readable Interpretation) format — to be placed on the label of the device and on all higher levels of packaging. For reusable devices, Article 27(4) also requires the UDI carrier to be applied directly to the device itself so that traceability is preserved across reprocessing.

Checklist items for Stage 6:

  • Generate the AIDC representation using the encoding rules of your chosen issuing entity.
  • Generate the HRI representation alongside the AIDC code where space permits.
  • Apply the UDI carrier to the unit label, the inner packaging, and the outer shipping carton, following the hierarchy defined by the issuing entity's rules.
  • For reusable devices, apply a permanent UDI carrier directly on the device — laser marking, etching, moulding, or other method that survives the reprocessing cycle.
  • Validate the readability of the UDI carrier after sterilisation, transport, and (for reusables) multiple reprocessing cycles. A UDI carrier that fails to scan after the first autoclave run is a finding.
  • Update the label master documents in the QMS and run a label change control before releasing the first batch.

Stage 7: Record-keeping of UDIs

Article 27(9) requires manufacturers to keep a list of all UDIs they have assigned and to keep this list updated. Distributors and importers have their own record-keeping obligations under Article 27(8) for Class III implantable devices supplied to healthcare institutions. Healthcare institutions have corresponding obligations under Article 27(8).

Checklist items for Stage 7:

  • Maintain a master UDI register inside the QMS that lists every Basic UDI-DI, every UDI-DI underneath it, and the period during which each was active.
  • Keep the register aligned with EUDAMED at all times. A mismatch between your internal register and EUDAMED is one of the fastest-to-spot audit findings.
  • Define the retention period for the register in line with MDR technical documentation retention rules (ten years after the last device placed on the market, fifteen for implantables).
  • Ensure the register survives company-level changes — QMS software migrations, acquisitions, or internal reorganisations must not lose the UDI history.

Stage 8: Sequencing — doing it in the right order

Even with every checklist item clear, startups get the sequencing wrong. Here is the dependency chain.

  1. SRN first. Without an SRN, you cannot submit anything else to EUDAMED and, under Article 31, you cannot legally place a device on the market as a manufacturer, AR, or importer.
  2. Basic UDI-DI grouping second. The grouping decision is upstream of every other identifier. Get it wrong and every label, every file reference, every EUDAMED entry has to be rebuilt.
  3. Issuing entity contract third. You cannot assign UDI-DIs without a contract in place. This is the longest-lead item.
  4. UDI-DI and UDI-PI assignment fourth. Once you have the issuing entity, the mechanical assignment is fast.
  5. Label carriers fifth. Labels are where the UDI becomes physical. Do not print production labels before the UDI assignment is confirmed.
  6. EUDAMED device registration sixth. Happens before first placing on the market and after the Notified Body has reviewed the relevant technical documentation for classes that require it.
  7. Record-keeping throughout. The internal UDI register runs in parallel from the moment the first UDI-DI is assigned.
  8. Place on the market. Only after all of the above.

Compress the sequence and you create rework. Rework at this stage of the project is the most expensive rework in the whole MDR path, because it touches labels, cartons, master data, EUDAMED entries, and the technical file simultaneously.

Common mistakes startups make

  • Treating Basic UDI-DI as a clerical step. It is a design-level decision. Wrong grouping forces a full label and file rebuild downstream.
  • Printing production labels before the issuing entity contract is signed. The label carrier has to match the issuing entity's encoding rules, so labels printed under assumptions are worthless.
  • Forgetting the PRRC on actor registration. Article 15 requires a PRRC for manufacturers and the PRRC data is part of Annex VI Part A Section 1. Missing PRRC data fails Competent Authority verification.
  • Mixing up the authorised representative's SRN and the manufacturer's SRN. Each has its own SRN. Both are required for non-EU manufacturers. Quoting the wrong one on a device registration is traceable and visible.
  • Assuming EUDAMED replaces national registration. It does not — not until the Commission declares a given module functional under Article 34 and the transitional period closes. Until then, the national obligations continue in parallel.
  • Treating the UDI register as a spreadsheet on one person's laptop. The register is a QMS record subject to the MDR retention rules. Treat it accordingly.

The Subtract to Ship angle

Every item on this checklist traces to a specific MDR article or to Commission Implementing Regulation (EU) 2021/2078. Nothing else belongs on the plan. When a consultant, a vendor, or an internal stakeholder adds a step, ask which article it serves. If the answer is not specific, the step is scope creep and should come off the plan.

The Subtract to Ship approach applied to EUDAMED and UDI produces a short, defensible sequence: one SRN, one clean Basic UDI-DI grouping, one issuing entity contract, one set of UDI-DIs and UDI-PIs tied to production records, one set of compliant label carriers, one accurate EUDAMED entry, one internal register. A small team can execute this. The complexity is not in the list; it is in getting the order right and keeping the data consistent across the QMS, the tech file, the label, and EUDAMED. For the underlying methodology see the Subtract to Ship framework for MDR.

Reality Check — Where do you stand?

  1. Do you have an SRN, and is it the same SRN quoted on every Notified Body document, every Competent Authority submission, and every internal record?
  2. Can you produce your Basic UDI-DI grouping rationale in writing, mapped to intended purpose, risk class, essential design, and manufacturing characteristics?
  3. Have you signed the contract with your UDI issuing entity, or is this still open?
  4. Is your UDI-PI generation tied to your batch records, so every physical unit traces back to a production lot?
  5. Is every data point in your planned EUDAMED device registration consistent with the same data in your technical file, your label, and your Declaration of Conformity?
  6. For a reusable device, does the UDI carrier applied to the device itself survive your full reprocessing cycle without degradation?
  7. Does your internal UDI register live inside the QMS with a defined owner, retention period, and change control?
  8. Can you describe the order in which you will execute the eight stages above, with a realistic timeline for each?

Four or fewer clean answers means EUDAMED and UDI work is an unresolved risk on your MDR plan.

Frequently Asked Questions

Do I need an SRN before I can register a device in EUDAMED? Yes. Device registration under MDR Article 29 is tied to the manufacturer's SRN. Without an SRN from the EUDAMED actor registration module under Article 31, there is no legal entity to attach the device record to. Actor registration is always the first step.

How many Basic UDI-DIs does a small startup typically need? It depends on how many distinct device families you place on the market. One Basic UDI-DI per family of devices that share intended purpose, risk class, essential design, and manufacturing characteristics. A startup with a single product usually has one; a startup with a platform product sold in multiple configurations may still have one if all configurations share those four criteria, or several if they do not.

Can I change my UDI issuing entity later? In practice, the choice is effectively permanent for a given product line. Changing issuing entity means reassigning UDI-DIs, reprinting labels, updating EUDAMED entries, and running a change control that will be visible to auditors. Choose once, carefully.

When does the UDI carrier need to be applied to the device itself versus just the label? MDR Article 27(4) requires direct marking on the device itself for reusable devices where the label carrier would not survive reprocessing. For single-use devices, the carrier on the label and higher-level packaging is sufficient under Article 27(4).

Is EUDAMED device registration mandatory today? It depends on the current functional status of the UDI and device registration module under MDR Article 34. Until the Commission declares the module functional and the transitional period ends, using it is possible on a voluntary basis while the corresponding national obligations remain in force. For the current status see EUDAMED status in 2026.

What happens if I place a device on the market without completing actor registration? Actor registration under Article 31 is a precondition for placing a device on the market as a manufacturer, authorised representative, or importer. Skipping it is a non-compliance that Competent Authorities treat as a serious market surveillance finding under Articles 93-100, and it exposes the company to enforcement action.

Do custom-made devices need EUDAMED device registration? Custom-made devices are outside the scope of the Article 29 device registration obligation. The manufacturer still needs actor registration under Article 31 and still falls under the UDI record-keeping logic where applicable, but the device registration submission itself does not apply in the same way. Confirm the scope carefully against Article 29(2) before relying on this.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 27 (UDI system), Article 28 (UDI database), Article 29 (registration of devices), Article 30 (electronic system on registration of economic operators), Article 31 (registration of manufacturers, authorised representatives and importers), Article 33 (European database on medical devices — Eudamed), Article 34 (functioning of Eudamed), Annex VI Parts A, B, and C (information to be submitted for registration of devices and economic operators, and Basic UDI-DI data elements). Official Journal L 117, 5.5.2017.
  2. Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 as regards the European Database on Medical Devices (Eudamed). Official Journal L 426, 29.11.2021.
  3. European Commission, EUDAMED information page — current module status, user guides, and Commission notices on functional declarations. Readers should consult the Commission page directly for the live mandatory/voluntary status of each module before acting.

This post is part of the EUDAMED, UDI and Registration category in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. The pillar post for this cluster is What is EUDAMED? and every item on this checklist traces back to a specific MDR article or to Commission Implementing Regulation (EU) 2021/2078. If the status of a specific module has changed since the last updated date on this post, the companion post on EUDAMED status is maintained as a living document and supersedes any time-sensitive statements here.