---
title: How to Register Your Startup as a Manufacturer in EUDAMED
description: Manufacturer registration in EUDAMED under MDR Article 31 produces your SRN. Here is the step-by-step process and the data you need ready.
authors: Tibor Zechmeister, Felix Lenhard
category: EUDAMED, UDI & Registration
primary_keyword: register manufacturer EUDAMED
canonical_url: https://zechmeister-solutions.com/en/blog/register-startup-manufacturer-eudamed
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# How to Register Your Startup as a Manufacturer in EUDAMED

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **To register your startup as a manufacturer in EUDAMED, you submit the Annex VI Part A, Section 1 data set through the EUDAMED actor registration module under MDR Article 31. The Competent Authority of the Member State where you are established verifies the submission and issues your Single Registration Number (SRN). The process has five steps: gather the Annex VI Part A data, access the EUDAMED actor registration module, submit the application, await Competent Authority verification and SRN issuance, and maintain the record as your company details change. You must be registered before placing a device on the Union market.**

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

---

## TL;DR

- MDR Article 31 requires manufacturers, authorised representatives and importers to register in the EUDAMED actor registration system before placing a device on the market, by submitting the information specified in Annex VI Part A, Section 1.
- MDR Article 30 establishes the electronic system on registration of economic operators that the actor registration module implements, and (EU) 2021/2078 sets out the detailed functioning rules.
- The Competent Authority of the Member State where the economic operator is established verifies the data and EUDAMED then issues the Single Registration Number (SRN).
- The data set is finite and known in advance. Preparing it cleanly before you open the submission form is the difference between a half-hour filing and a three-week ping-pong with the Competent Authority.
- Registration is not a one-off event. Annex VI Part A requires the information to be kept up to date, and any material change to the entity (address, PRRC, legal form) triggers an update obligation.

---

## The founder who opened the form before reading Annex VI

The most common failure mode in actor registration is not technical. It is that the founder opens the EUDAMED actor registration screen, sees a form, and starts typing. Without having read Annex VI Part A first. Halfway through they hit a field they cannot answer without going back to their articles of incorporation, another one that needs the appointed PRRC's full details, and a third one that asks for information their authorised representative never sent them. They save a draft, promise to come back to it, and three weeks later the submission is still half-finished.

The fix is unglamorous. Before you touch the form, read Annex VI Part A, Section 1 of Regulation (EU) 2017/745. Prepare every field on paper (or in a spreadsheet). Then open EUDAMED and enter the data once, cleanly, in a single sitting. This post walks that process step by step, in the order it actually has to happen.

## What the Regulation requires

MDR Article 31 is the substantive obligation. It requires manufacturers, authorised representatives, and importers. Before placing a device on the market (or, for authorised representatives and importers, before making a device available). To submit to the actor registration system the information referred to in Annex VI, Part A, Section 1, provided that this information has not already been submitted. Article 31 also makes clear that the Competent Authority of the Member State verifies the data and confirms it, after which EUDAMED assigns the Single Registration Number. The SRN is then used by the economic operator when applying to a Notified Body for conformity assessment and for accessing EUDAMED to fulfil subsequent obligations under Article 29.

MDR Article 30 is the enabling provision. It establishes the electronic system on registration of economic operators, which the Commission sets up and manages, and requires Member States to use it to collate and process the information necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative and the importer.

The detailed functioning rules. Registration procedures, access rights, data ownership, security, and the technical operation of the module. Are laid down in Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021.

The data set itself is in Annex VI, Part A. That is the operative list you have to prepare.

## Step 1. Gather the Annex VI Part A data

Annex VI, Part A, Section 1 specifies the information to be submitted for registration of manufacturers, authorised representatives, and importers. The fields include the type of economic operator, the name, the address of the registered place of business, the contact details of the entity, and the name and contact details of the person(s) responsible for regulatory compliance referred to in Article 15 (the PRRC). Section 1.2 covers additional identification information used to confirm the identity of the economic operator. Read the Annex directly for the exact field list that applies on the day you file, because the module implements Annex VI as it stands.

Translated into a practical preparation checklist, you need the following ready before you touch the form.

**Legal entity identification.** The full legal name of the company exactly as it appears on the register of commerce or equivalent, the legal form (GmbH, Ltd, SAS, etc.), the registered office address, the registration number from the relevant national business register, and a VAT identification number where applicable.

**Economic operator type.** Whether you are registering as a manufacturer, an authorised representative, or an importer. A startup that is the legal manufacturer of its own device registers as "manufacturer." If the startup is established outside the Union, the authorised representative registers on the manufacturer's behalf. See [authorised representatives under MDR](/blog/authorized-representatives).

**Contact details.** A general contact email, a telephone number, and a website. These are not decorative fields. The Competent Authority uses them to reach you during verification. Use a monitored inbox, not a founder's personal email that will be orphaned when the founder leaves.

**PRRC information.** The name and full contact details of the Person Responsible for Regulatory Compliance under MDR Article 15. For startups that qualify for the micro- and small-enterprise derogation under Article 15(2), the PRRC can be available on a permanent and continuous basis rather than internal to the organisation. But you still need the named person, their qualifications on file (Article 15(1) sets the qualification requirements), and their contact details. See [PRRC options for startups](/blog/prrc-options-startups) if this is the first time you are thinking about it.

**Natural or legal person making the submission.** The person who actually files. Typically the PRRC or a designated regulatory lead. Needs their own identity data and a valid EU Login account to access EUDAMED.

**Authorised representative details (non-EU manufacturers only).** If your manufacturing entity is established outside the Union, you must have an authorised representative appointed under MDR Article 11 before you submit, and their details are part of the filing.

**Importer details, where relevant.** Importers register separately under their own Article 31 obligation, but if your commercial setup involves importers you will want their registration status clear so the downstream device registration is coherent.

Write this list onto one document before you open EUDAMED. When a Competent Authority rejects a submission, it is almost always because one of these fields was wrong, missing, or inconsistent with the public business register.

## Step 2. Access the EUDAMED actor registration module

EUDAMED is accessed through the European Commission's EUDAMED information page. The actor registration module is the entry point for economic operators and is separate from the public front end that allows the general public to browse registered entities and devices.

To file, the person submitting needs an EU Login account (the Commission's authentication service). If you or your PRRC do not already have one, create it first. It takes a few minutes and is free. With the EU Login in hand, you access the EUDAMED actor registration module through the Commission's EUDAMED portal, select "Register as a new actor" (or the equivalent current wording), and select the type of economic operator from the drop-down.

A detail worth naming: the actor registration module has been available on a voluntary basis for an extended period, and the current mandatory status of the module is determined by Commission notices under MDR Article 34. Before you file, check the companion post [EUDAMED status in 2026](/blog/eudamed-status-2026) and the Commission's EUDAMED information page for the live status. If the module is already mandatory for your situation, the filing is compulsory and discharges your Article 31 obligation. If it is still voluntary, the filing is permitted and sensible but does not replace any parallel national obligation still in force. You must continue to meet that national obligation until the Commission declares the module mandatory and the transitional period runs.

## Step 3. Submit the actor registration application

With Annex VI Part A data prepared and the form open, enter the information in a single sitting. A few operational rules make this step survivable.

**Type every field from your prepared document, not from memory.** The single largest cause of Competent Authority corrections is a transcription error between the company's business register and the EUDAMED submission. The legal name, address, and registration number must match the public register exactly.

**Name one natural person as the single point of contact for the Competent Authority.** This is the person the authority will call if something is unclear. It should be the PRRC or the regulatory lead. Not the CEO, not a generic inbox.

**Attach the supporting documents the module asks for.** Depending on the Member State and the current module version, supporting documents may include proof of the legal entity (extract from the business register), the appointment of the PRRC, and (for non-EU manufacturers) the authorised representative mandate. Have these ready as PDFs before you start, named clearly.

**Double-check the economic operator type and the Member State of establishment.** Selecting the wrong Member State routes the verification to the wrong Competent Authority and delays the process. Your Member State of establishment is where your registered office sits, which is also the Member State whose business register you appear on.

**Submit.** The system gives you a confirmation of submission with a reference number. Record this reference in your quality records. It is the first piece of evidence that your Article 31 obligation is in progress.

If the module's current version supports draft-saving, still try to complete the submission in one sitting. Drafts are where forms go to die.

## Step 4. Await SRN issuance by the Competent Authority

Once you submit, the application is routed to the Competent Authority of the Member State where your organisation is established. The Competent Authority verifies the data against the business register and against the supporting documents you attached. If the data is consistent, the authority confirms the submission and EUDAMED issues your Single Registration Number.

Timelines vary by Member State. Some authorities turn around submissions in a few working days, others take weeks, and the variation depends on the authority's internal workload and how clean your submission was. Chase-ups by the founder rarely help and sometimes backfire. The verification is a legal act and proceeds at the authority's cadence.

What you can do while you wait.

**Monitor the contact inbox you gave in Step 1.** The authority contacts that address directly if anything is unclear. A missed email is the most common cause of avoidable delay.

**Prepare the downstream work.** Your SRN is the key to device registration under MDR Article 29, to the UDI assignments on your labels, to the certificate data your Notified Body will enter, and to the EUDAMED modules that depend on a registered actor. Use the waiting time to finish the Annex VI Part B data for devices, to finalise your UDI issuing-entity choice, and to lock down your Basic UDI-DI grouping. See [device registration in EUDAMED](/blog/device-registration-eudamed) and [the Basic UDI-DI explained](/blog/basic-udi-di-explained).

**Do not place a device on the market yet.** Article 31(1) conditions market placement on the registration being submitted, and downstream steps (Article 29 device registration, SSCP publication for Article 32 devices, Notified Body certificate entry) all expect a valid SRN. Wait.

When the SRN is issued, the module sends you a notification. Record the SRN in your quality records, write it into the header of your technical documentation cover sheet, and make sure every downstream regulatory artefact (Notified Body application, device labels where the SRN is referenced, authorised representative file) reflects it.

For a deeper look at what the SRN is, what it controls, and what its permanence implies, see [what is the Single Registration Number (SRN)](/blog/single-registration-number-srn).

## Step 5. Maintain the registration

The Article 31 obligation is continuous, not a one-time filing. Annex VI Part A requires the information to be kept up to date. Any change that would make your registered data inaccurate is an update obligation.

The practical rule is that the following changes trigger an update, without exception. A change of registered office address. A change of legal form or corporate restructuring. A change in the PRRC. Either the person or their contact details. A change in the authorised representative (for non-EU manufacturers). A change in the name of the legal entity. A change in the contact details the authority uses to reach you. A withdrawal or winding up of the entity.

Update promptly. Do not batch updates for convenience. The Competent Authority re-verifies the changed data and the updated record is what every downstream module uses, including Notified Body access for surveillance audits. Inconsistency between EUDAMED and your real-world legal state is a finding waiting to happen.

A written internal procedure for "when to update EUDAMED" is something your Notified Body will expect to see during a QMS audit. Keep it short, keep it specific, and name the triggers above explicitly.

## Common mistakes

- **Opening the form before reading Annex VI Part A.** The submission fails because the founder hits unfamiliar fields mid-form.
- **Using a personal email as the contact address.** The founder leaves, the address is orphaned, and the Competent Authority's follow-up never reaches anyone.
- **Typos between the business register and the submission.** A one-character difference in the legal name or registration number is enough to bounce the application.
- **Filing as the wrong type of economic operator.** A manufacturer that also imports another company's device is not an "importer" for its own device. Registering under the wrong type corrupts every downstream filing.
- **Selecting the wrong Member State of establishment.** Routes the verification to the wrong authority and wastes weeks.
- **Forgetting to name the PRRC.** Article 15 requires the manufacturer to have a PRRC available; Annex VI Part A requires the PRRC to be in the registration data. Missing either blocks the submission.
- **Treating the registration as one-off.** The record is never updated, and a later audit finds the EUDAMED entry disagrees with the current corporate reality.
- **Starting downstream work without the SRN.** Device registration under Article 29 and Notified Body applications both depend on a valid SRN. Pre-launching them without it creates rework.

## The Subtract to Ship angle

Actor registration is a finite, well-specified task. MDR Article 31 plus Annex VI Part A tells you exactly what to do. The work that should survive in your plan is the work that traces to those two provisions: gather the data, submit it, wait for the SRN, maintain it. Everything else. The "EUDAMED readiness assessment," the "actor registration workshop," the external consultant who wants to charge three days of work for a one-hour filing. Does not belong in a resource-constrained plan.

The single exception is when your structure is genuinely unusual: a non-EU manufacturer with a complex distribution chain, a legal entity mid-restructuring, a PRRC arrangement that straddles the Article 15(2) derogation and an external provider. Those cases benefit from a one-hour conversation with someone who has done the filing dozens of times. But the one-hour conversation is the scope, not a three-month engagement.

See [the Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr) for the methodology this applies.

## Reality Check. Where do you stand on actor registration?

1. Have you read Annex VI, Part A, Section 1 in the current consolidated MDR text, or are you working from a summary somebody gave you?
2. Is your legal entity data (name, registered office, business register number, legal form) prepared exactly as it appears on your national business register?
3. Do you have a named PRRC under Article 15, with contact details and qualification evidence on file, ready to be listed in the submission?
4. Is the contact email you will give the Competent Authority a monitored, role-based inbox rather than a personal address?
5. If you are established outside the Union, do you have an authorised representative appointed under Article 11 with a signed mandate?
6. Have you checked the current Commission notices on EUDAMED actor registration module status, so you know whether the filing is mandatory for you today or still parallel to a national obligation?
7. Do you have an internal procedure that names the events that will trigger an update to your EUDAMED actor registration record?

If you cannot answer five or more of these cleanly, do not open the form yet. Prepare first.

## Frequently Asked Questions

**Who must register as a manufacturer in EUDAMED?**
Under MDR Article 31, every manufacturer placing a device on the Union market must be registered before the device is placed on the market. Unless the information has already been submitted. The obligation runs with the legal manufacturer of the device, not with distributors. For non-EU manufacturers, the authorised representative performs the registration on the manufacturer's behalf as part of its role under Article 11.

**What data do you need to prepare for the actor registration?**
The data set is specified in Annex VI, Part A, Section 1. It includes the type of economic operator, legal entity name, registered address and contact details, identification data (including business register entries), and the name and contact details of the PRRC under Article 15. Prepare every field from source documents before you open the form.

**How long does it take to get an SRN?**
Timelines vary by Member State because the Competent Authority of the Member State where you are established is the verifier, and authorities have different internal workloads. A clean submission from a startup with straightforward data typically moves faster than one with inconsistencies or missing supporting documents. The Regulation does not set a fixed statutory deadline for verification in Article 31.

**Can you register before having a PRRC?**
No. The PRRC information is part of the Annex VI Part A data set. Manufacturers must have a PRRC in place (Article 15) before they can submit a complete actor registration. For startups that qualify, the Article 15(2) derogation allows the PRRC to be available on a permanent and continuous basis rather than internal. But you still need the named person and their contact details.

**Does voluntary registration replace your national obligations?**
No. If the EUDAMED actor registration module is still voluntary for your situation (because the Commission has not yet declared it mandatory under Article 34 for your obligation), any parallel national actor registration or notification obligation remains in force. Registering voluntarily in EUDAMED is sensible for data-discipline reasons, but it is additive, not substitutive. See [EUDAMED status in 2026](/blog/eudamed-status-2026).

**What happens if your company data changes after registration?**
Annex VI Part A requires the data to be kept up to date. Material changes. Address, legal form, PRRC, authorised representative, entity name. Must be reflected in the EUDAMED record through an update. The updated data is re-verified by the Competent Authority and becomes the current record for every downstream module.

**Where do you find the EUDAMED actor registration module?**
Through the European Commission's EUDAMED information page. You need an EU Login account to access the module. The Commission page also links to the user guides and the current status notices under Article 34.

## Related reading

- [What is EUDAMED? The European Database on Medical Devices explained](/blog/what-is-eudamed-european-database-medical-devices) – the pillar post for the EUDAMED cluster.
- [EUDAMED status in 2026](/blog/eudamed-status-2026) – the live view of which modules are mandatory and which are voluntary.
- [What is the Single Registration Number (SRN)?](/blog/single-registration-number-srn) – the identifier the actor registration produces.
- [Device registration in EUDAMED](/blog/device-registration-eudamed) – the next step after you have an SRN.
- [Updating your EUDAMED actor registration](/blog/updating-eudamed-actor-registration) – the maintenance process for existing records.
- [EUDAMED and UDI compliance checklist](/blog/eudamed-udi-compliance-checklist) – the consolidated readiness list for the whole cluster.
- [Authorised representatives under MDR](/blog/authorized-representatives) – the role that files the actor registration for non-EU manufacturers.
- [MDR importers and distributors](/blog/mdr-importers-distributors) – the other economic-operator registrations that touch the same module.
- [The Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr) – the methodology for cutting registration work down to what Article 31 actually requires.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 30 (electronic system on registration of economic operators), Article 31 (registration of manufacturers, authorised representatives and importers), Article 15 (Person Responsible for Regulatory Compliance), Article 11 (authorised representative), and Annex VI Part A, Section 1 (information to be submitted for registration of economic operators). 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 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed). OJ L 426, 29.11.2021.
3. European Commission, EUDAMED information page. Actor registration module access, user guides, EU Login account setup, and current Commission notices on functional declarations under MDR Article 34. Readers should consult this page directly for the live operational status of the module on the day they file.

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*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. Actor registration is a finite task with a specified data set; the value of doing it well is that every downstream EUDAMED activity depends on a clean SRN record, and a clean record costs no more to produce than a sloppy one.*

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*This post is part of the [EUDAMED, UDI & Registration](https://zechmeister-solutions.com/en/blog/category/eudamed-udi) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*