---
title: National Registration Requirements in EU Member States: What EUDAMED Does Not Replace
description: EUDAMED is not a one-stop register. National registration duties continue in France, Germany, Italy, Belgium and more. Here is what still applies.
authors: Tibor Zechmeister, Felix Lenhard
category: EUDAMED, UDI & Registration
primary_keyword: national medical device registration EU member states
canonical_url: https://zechmeister-solutions.com/en/blog/national-registration-eu-member-states
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# National Registration Requirements in EU Member States: What EUDAMED Does Not Replace

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

> **EUDAMED is the EU-level register for medical devices and economic operators under MDR Articles 29, 31 and 33, but it is not a single stop for placing a device on every national market. Under MDR Article 34, individual EUDAMED modules become mandatory only as the Commission declares them functional, and until that declaration national Member State duties continue in parallel. France, Germany, Italy, Belgium and several other Member States still maintain national notification, language, representative, or distributor-registration obligations that sit on top of the EUDAMED path. A manufacturer selling across multiple EU markets must therefore treat national registration as an active layer per country, not as a task that EUDAMED has already completed on its behalf.**

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

---

## TL;DR

- EUDAMED under MDR Article 33 is the EU-level database for economic operators, devices, certificates, clinical investigations, vigilance, and market surveillance.
- MDR Article 34 governs how and when each EUDAMED module becomes mandatory, and national duties continue in parallel where a module is not yet mandatory.
- Several Member States — including France, Germany, Italy, and Belgium — maintain national notification, distributor registration, language, or importer duties alongside EUDAMED.
- Economic operator registration under MDR Article 31 runs through EUDAMED and is verified by the Competent Authority of the Member State of establishment, but the market-of-sale Member State keeps its own surveillance and language obligations regardless.
- The Subtract to Ship rule: maintain one clean EU-level EUDAMED foundation, then keep a per-country register of the national duties that still apply — do not assume EUDAMED has already done the national layer's work.

---

## The founder who thought EUDAMED was the one-stop shop

A CEO cornered us at a conference and asked, with real confidence in his voice, whether his EUDAMED registration meant he could now sell across all 27 Member States without any further country-level registration paperwork. His regulatory consultant had told him EUDAMED was "the single European register." He had built his launch plan around that sentence.

The sentence is not wrong — EUDAMED is the single European register at EU level. It is also not the whole truth. EUDAMED is one layer. Underneath it, the national frameworks that existed before MDR became applicable have not all disappeared. Some have been harmonised against EUDAMED. Some are running in parallel while the relevant EUDAMED module is still transitioning under MDR Article 34. Some are specifically retained as national market surveillance or language duties that the MDR itself allows Member States to enforce. A founder who treats EUDAMED as a one-stop shop will walk into every national market with a gap they did not plan for.

This post is the general framing. The per-country deep dives — ANSM in France, BfArM in Germany, the Italian Ministry of Health, AEMPS in Spain, the Belgian FAMHP — live in their own posts and are linked at the bottom.

## What EUDAMED actually replaces

Under Regulation (EU) 2017/745, EUDAMED is the European database established by MDR Article 33. It is structured into six modules: actor registration, UDI and device registration, Notified Body and certificate information, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance. (Regulation (EU) 2017/745, Article 33, paragraph 2.)

Economic operators — manufacturers, authorised representatives, and importers — register through the actor module under MDR Article 31. Devices are registered under MDR Article 29 using the Basic UDI-DI as the core identifier, and system and procedure packs under MDR Article 30. Notified Body certificates are uploaded by the Notified Body itself. Vigilance reports and field safety corrective actions flow through the vigilance module once that module is mandatory. Market surveillance activities are coordinated through the surveillance module.

The point of EUDAMED is to replace the patchwork of national databases that existed under the old Directives 93/42/EEC and 90/385/EEC with a single EU-level register that every Competent Authority and the public can consult. Where EUDAMED is fully operational and mandatory, it is the primary register. A manufacturer who has a Single Registration Number, clean actor data, a Basic UDI-DI registration for each device, and current certificate information has done the EU-level register correctly.

That is what EUDAMED replaces. What it does not replace is everything a Member State is still entitled to require under its own national framework or under the parts of MDR that explicitly hand duties back to the Member State.

## What MDR Article 34 actually says about the transition

MDR Article 34 governs the functionality of EUDAMED. The original MDR text set a single go-live date tied to the Commission's confirmation that EUDAMED was fully functional. That single-switch model has been replaced in practice by a module-by-module rollout: each EUDAMED module becomes mandatory only once the Commission has declared it functional and the corresponding notice has been published in the Official Journal. Until then, the pre-MDR obligations applicable to the corresponding area — including national notification and reporting routes — continue to apply.

The practical consequence for a founder is that "EUDAMED" is not a single status. On any given day, some modules are mandatory, some are voluntary, and some are still in transition. A module that is mandatory for actor registration does not mean the vigilance module is mandatory. A fully mandatory device registration module does not mean national market surveillance notification has disappeared.

Any founder planning a multi-country launch needs to know the current status of each EUDAMED module at the time of launch, not the status at the time they read a blog post six months earlier. The module status changes. The MDR article anchors do not. This post cites the anchors; the live module status belongs on the Commission's EUDAMED information page and should be checked at launch time.

## What still lives at national level — the country-by-country picture

Below is the general framing for the Member States founders most commonly ask about. Each of these has its own dedicated post; this section is the shape of the problem, not the details per country.

**France.** ANSM is the French Competent Authority. France has historically maintained national notification obligations for certain device categories on top of EUDAMED, and it imposes French-language requirements on label and IFU under the French application of MDR Annex I Chapter III. ANSM also remains the receiving authority for vigilance reports involving serious incidents on the French market under MDR Articles 87 to 92. See [the ANSM France post](/blog/ansm-registration-france) for the detailed framing.

**Germany.** BfArM is the German federal Competent Authority and BfArM has historically operated the DMIDS national database for medical devices placed on the German market. Germany also requires German-language labelling and IFU and has specific rules on distributor and importer duties at national level. See [the BfArM Germany post](/blog/bfarm-registration-germany) for detail.

**Italy.** The Italian Ministry of Health has historically operated a national medical device register — the Repertorio — that runs on top of EUDAMED and that procurement bodies in the Italian public health service reference directly. For practical access to the Italian market, inclusion in the Repertorio is often the de facto gate even where EUDAMED registration is complete. Italian-language requirements apply.

**Belgium.** The Federal Agency for Medicines and Health Products (FAMHP) is the Belgian Competent Authority and Belgium retains specific distributor-notification obligations at national level. Belgium has multiple official languages, which affects the language layer differently than France or Germany.

**Spain.** AEMPS is the Spanish Competent Authority and Spain has historically operated national communication and registration duties on certain categories of device at the Autonomous Community level as well as at the national level. Spanish-language requirements apply.

**Smaller and newer Member States.** Almost every EU Member State retains some layer of national duty — language requirements are the most common, followed by distributor notification, importer duties, and specific device-category registers. The density of those duties varies widely.

The general rule: assume every Member State has some national layer. Verify it per country before launch. Do not assume EUDAMED has already cleared it.

## Test: a multi-country launch scenario

Imagine a Class IIa software-as-a-medical-device startup, incorporated in Austria, with CE certification in hand and a Basic UDI-DI registered in EUDAMED. They are about to launch simultaneously in Austria, Germany, France, Italy, and Belgium. What does the national layer actually look like across those five markets?

At EU level, one thing has happened: the Austrian Competent Authority (BASG) has verified the actor registration under MDR Article 31 and issued the SRN. The device is registered under MDR Article 29 with its Basic UDI-DI. The Notified Body certificate is in EUDAMED. That is the EU-level foundation, and it applies identically across all five markets.

At national level, five separate things still need to be checked:

1. **Austria.** BASG is both the registering Competent Authority and the market Competent Authority — so the national layer here is simpler, but German language requirements apply and Austrian national surveillance duties continue.
2. **Germany.** BfArM is the market surveillance authority. Any DMIDS or national notification duties applicable to the device class need to be checked. German language applies to label and IFU.
3. **France.** ANSM is the market surveillance authority. Current ANSM guidance on national notification for the device class must be verified. French language applies to label and IFU.
4. **Italy.** The Ministry of Health is the market surveillance authority. The Repertorio status needs to be checked — for many device categories, Repertorio inclusion is in practice required for public procurement access. Italian language applies.
5. **Belgium.** The FAMHP is the market surveillance authority. Belgian distributor notification duties need to be checked. Language requirements depend on region.

Five markets. One EU-level foundation. Five different national layers. A founder who launches without that national layer mapped is launching with open flanks.

## Ship: the national registration tracker playbook

The operational tool for keeping the national layer under control is a simple tracker. Build it once, maintain it quarterly, and never launch into a new Member State without updating it first.

The tracker is a single table with one row per Member State you sell or plan to sell into. The columns are:

- **Country.**
- **Competent Authority (name, URL, contact point).**
- **EUDAMED SRN verification authority** — the Member State of establishment that verified the SRN under MDR Article 31.
- **National notification or database status** — what national duty, if any, applies for your device class (and the date you last verified it).
- **Language requirement for label and IFU.**
- **Authorised representative requirement** — whether an EU-authorised representative is needed (for non-EU manufacturers) and who it is.
- **Importer and distributor duties at national level.**
- **Vigilance reporting contact** — the authority to which serious incidents occurring in that country must be reported under MDR Article 87.
- **Market surveillance authority** — usually the same as the Competent Authority, with the reference to MDR Article 93.
- **Last verified date** — the date you checked national guidance, not the date the row was first filled.

The tracker lives in one file, in one place, with one owner. It is updated before every new-country launch. It is reviewed quarterly as part of the QMS management review. It is the single internal source of truth for "what does country X require of us that EUDAMED has not already handled."

This is not a consulting deliverable. It is a founder's working document. The act of maintaining it forces the regulatory posture that a real multi-market presence demands.

## Common mistakes

- Treating EUDAMED as a one-stop shop and skipping national registration verification entirely.
- Assuming that because the actor module is mandatory under MDR Article 31, every other national duty has disappeared.
- Copying another startup's country list without checking that their device class, risk class, and business model match yours.
- Maintaining the national layer knowledge in one regulatory person's head rather than in a shared tracker — the day that person leaves is the day the gaps surface.
- Discovering the French or Italian language requirement after stock is already on the shelf.
- Forgetting that vigilance reporting under MDR Article 87 routes to the Competent Authority of the Member State where the incident occurred, not the Member State where the SRN was issued.

## The Subtract to Ship approach

The Subtract to Ship rule for national registration is: keep one clean EU-level foundation, keep one national tracker, and cut everything else. The EU-level foundation is MDR Article 31 actor registration, MDR Article 29 device registration, current SRN, current PRRC under MDR Article 15, current authorised representative (where applicable), current Notified Body certificate. That is fixed and cannot be subtracted.

The national tracker is the minimum operational overlay. It is one file, one owner, one quarterly review. It is not a consulting dossier, a bespoke national QMS add-on, or a separate regulatory project per country. Everything beyond the EUDAMED foundation and the tracker needs a specific MDR article, a specific Member State legal basis, or a specific verified current national guidance reference to justify it. No article, no basis, no reference — it gets subtracted.

## Reality Check — Where do you stand on national registration?

1. Can you name, for every Member State you sell into, the Competent Authority and the current status of national notification duties for your device class?
2. Is your label, IFU, and (where applicable) implant card text available in the required language(s) for every Member State on your launch list?
3. Do you have a single internal tracker that shows the national layer per country, with a "last verified" date under six months old?
4. If a serious incident happened in Italy tomorrow, do you know which authority the report goes to and within what MDR Article 87 timeline?
5. Have you distinguished between "EUDAMED module is mandatory" and "national obligation has ceased" rather than assuming the two are the same?
6. Is your authorised representative under MDR Article 11 (where applicable) correctly named and current across EUDAMED and every national register that still requires the information?
7. Can you defend each Member State entry in your tracker against a Competent Authority inspection using the actual current national guidance, not a blog post or a consultant's memory?

If more than two of these are unanswered, EUDAMED is giving you a false sense of completeness. The national layer is where the real exposure is.

## Frequently Asked Questions

**Does EUDAMED replace all national medical device registration in the EU?**
No. EUDAMED is the EU-level register under MDR Article 33, but MDR Article 34 governs when each module becomes mandatory, and until then national duties continue in parallel. Several Member States also retain national notification, language, and distributor duties on top of EUDAMED regardless of module status.

**Which EU countries still require national medical device registration on top of EUDAMED?**
The specific duties vary by Member State and by device class. France, Germany, Italy, Belgium, and Spain are among the Member States that most commonly require a national-layer action alongside EUDAMED — whether that is a national notification, a national database entry, a language-specific label, or a distributor-registration duty. The per-country deep-dive posts cover the details.

**If I register in EUDAMED, do I still need a national Single Registration Number per country?**
No. The Single Registration Number under MDR Article 31 is issued once, by the Competent Authority of the Member State where the economic operator is established. It is recognised across the EU. National registration duties that may still apply are separate from the SRN and do not change that principle.

**Who verifies my economic operator registration under MDR Article 31?**
The Competent Authority of the Member State where the economic operator is established. For a manufacturer based in Germany, that is BfArM. For a manufacturer based in France, ANSM. For a non-EU manufacturer, the verification happens through the Member State where the authorised representative under MDR Article 11 is established.

**Where do I report a serious incident if my device is sold across several EU countries?**
To the Competent Authority of the Member State where the incident occurred, under MDR Articles 87 to 92. Your internal vigilance process must route incidents based on the country of occurrence, not the country where the SRN was issued.

**How often should I update my national registration tracker?**
Quarterly at minimum, and always before entering a new Member State. National frameworks are evolving alongside the EUDAMED transition under MDR Article 34, and a six-month-old position may already be out of date.

## Related reading

- [What is EUDAMED? The European Database on Medical Devices explained for startups](/blog/what-is-eudamed-european-database-medical-devices) — the EUDAMED pillar this post links up to.
- [ANSM registration: the French national layer](/blog/ansm-registration-france) — the French Competent Authority and its national duties alongside EUDAMED.
- [Single Registration Number (SRN) under MDR Article 31](/blog/single-registration-number-srn) — the EU-level actor identifier and how it is issued.
- [BfArM registration: the German national layer](/blog/bfarm-registration-germany) — the German counterpart to ANSM.
- [Market surveillance and Competent Authorities under MDR](/blog/market-surveillance-competent-authorities) — how national authorities exercise MDR Article 93 powers.
- [The Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr) — the underlying methodology for cutting national-layer work to what actually applies.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, 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 (functionality of Eudamed), Articles 87-92 (vigilance), Article 93 (market surveillance), Annex VI Part A (information to be submitted on actor registration), Annex I Chapter III (labelling and IFU language). 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). OJ L 426, 29.11.2021.
3. European Commission — EUDAMED information page and module status notices. Readers should consult the current status of each EUDAMED module directly before relying on a specific transitional assumption.
4. National Competent Authority published guidance — ANSM (France), BfArM (Germany), Italian Ministry of Health, AEMPS (Spain), FAMHP (Belgium), BASG (Austria). The live status of each Member State's national notification, language, and distributor duties should be verified against the current published guidance of the Competent Authority in question before launch.

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*This post sits in the EUDAMED, UDI and Registration cluster of the Subtract to Ship: MDR blog and links up to the EUDAMED pillar. Authored by Felix Lenhard and Tibor Zechmeister. The specific per-country national registration positions age quickly as Member States adjust their frameworks to the EUDAMED transition under MDR Article 34; the MDR article anchors in this post are stable, but the national-layer specifics should be verified against current Competent Authority guidance at launch time.*

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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).*