Germany's Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) is the federal Competent Authority for medical devices placed on the German market. Under MDR Article 31, economic operator registration routes through EUDAMED, and the Competent Authority of the Member State where the operator is established verifies that data. Alongside the EUDAMED path, Germany operates its own national medical device information system — DMIDS — administered under the Medizinprodukterecht-Durchführungsgesetz (MPDG), the German law implementing the MDR. Until the relevant EUDAMED modules are fully mandatory under MDR Article 34, German national duties run in parallel, and manufacturers selling into Germany should treat BfArM and DMIDS as an active regulatory layer, not as duplicates of EUDAMED.

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

TL;DR

  • BfArM is Germany's federal Competent Authority for medical devices and the German counterpart to ANSM in France or BASG in Austria.
  • MDR Article 31 is the legal anchor for economic operator registration; it runs through EUDAMED, with verification by the Competent Authority of establishment.
  • Germany maintains its own national information system, DMIDS (Deutsches Medizinprodukteinformations- und Datenbanksystem), administered under the MPDG — the national law implementing the MDR.
  • For a non-German manufacturer selling into Germany, BfArM is relevant through vigilance, market surveillance, and national-layer notifications that sit alongside the EUDAMED path under MDR Article 34.
  • The Subtract to Ship rule: do the MDR Article 31 EUDAMED work cleanly, then verify the current DMIDS and BfArM position for your specific device class rather than copying a peer company's setup.

A founder calls us the morning of the German hospital demo

A founder due to demo a Class IIa monitoring device in a German university hospital called us the day before. The hospital's procurement team had asked for "the German registration number" and the founder did not know what that meant. They had an SRN from EUDAMED, a CE certificate from a Notified Body, and a German-language IFU. Was that enough, or was there a separate BfArM step they had missed?

The short answer is that EUDAMED plus CE plus the PRRC under MDR Article 15 is the MDR foundation, but Germany also has a national layer administered through DMIDS under the MPDG, and what "German registration" means in a given conversation depends on which obligation the procurement team has in mind. This post walks through the layers so a founder can answer that question with confidence the first time a German hospital asks it.

The German registration framework at general level

Germany's medical device regulatory architecture is the same two-layer structure you find in every EU Member State, but the German layer has its own distinct shape.

The first layer is the EU-level MDR framework. Regulation (EU) 2017/745 is directly applicable in Germany. Economic operators register under MDR Article 31, devices register under MDR Article 29, and both registrations route through EUDAMED under MDR Article 33. The Competent Authority of the Member State where the operator is established verifies the actor data and issues the Single Registration Number. For a manufacturer established in Germany, that Competent Authority is BfArM at the federal level. For a non-German manufacturer placing a device on the German market, actor registration happens in the manufacturer's own Member State — or via an authorised representative established in the EU — and BfArM becomes relevant as the Competent Authority of the market where the device is sold.

The second layer is the German national framework. Germany implements the MDR through the Medizinprodukterecht-Durchführungsgesetz (MPDG), the national law that replaced the old Medizinproduktegesetz (MPG) when MDR became applicable. The MPDG sets out national duties that complement the MDR: competent authority structure, language requirements, vigilance routing, national notification obligations for specific activities, and enforcement powers. Alongside the MPDG, Germany operates DMIDS — the Deutsches Medizinprodukteinformations- und Datenbanksystem — as the national information and notification portal. The direction of travel under MDR Article 34 is toward EUDAMED as the single EU register, but national obligations under MPDG continue in parallel until the relevant EUDAMED modules are fully mandatory.

The practical rule for this post: the EU-level obligations under MDR Article 31 are fixed and can be stated with precision. The specific German national notifications under MPDG and DMIDS are a matter of German domestic law and change as the German ministry adjusts the national framework to the EUDAMED timeline. Founders should verify the current BfArM and DMIDS position for their specific activity and device class rather than rely on a static description.

What BfArM and DMIDS require beyond EUDAMED

Even when a manufacturer's EUDAMED actor and device registration is clean, BfArM remains an active regulatory counterpart for devices on the German market. Four areas matter most.

Vigilance and incident reporting. Under MDR Articles 87 to 92, manufacturers report serious incidents and field safety corrective actions to the Competent Authority of the Member State where the incident occurred. If a serious incident involving your device happens in a German hospital, the report goes to BfArM — regardless of where your company is registered in EUDAMED.

Market surveillance. BfArM and the German Länder market surveillance authorities can inspect manufacturers, authorised representatives, importers, and distributors active on the German market under MDR Articles 93 to 100. That includes requesting technical documentation, demanding samples, and taking enforcement action where non-compliance is found. German market surveillance is well-resourced and active — "I am registered in another Member State" is not a defence against a BfArM enforcement action on the German market.

National notifications through DMIDS. Germany historically operated national notifications for certain events and activities — clinical investigations, certain device categories, changes to operators, and specific vigilance communications. Under the MPDG and DMIDS, some of these notifications continue in a form adapted to the EUDAMED transition.

Clinical investigations in Germany. Clinical investigations of medical devices in Germany are authorised under MDR Articles 62 to 82, with German implementation via the MPDG and coordination between BfArM and the relevant ethics committees.

Notification versus authorisation — the German version

Founders new to German regulatory work sometimes conflate registration, notification, and authorisation. The MPDG keeps the same distinction as the MDR, and it matters for any German interaction.

Registration puts the operator and the device on a register — EUDAMED at EU level, DMIDS at German national level where still applicable. Registration does not grant permission to sell. CE marking under MDR and, where required, a valid Notified Body certificate are what actually permit market placement.

Notification is a communication to the Competent Authority that a specific event or state has occurred — a device placed on the market, a clinical investigation starting, a serious incident reported, an authorised representative changed. Notifications are generally informational, not permission-granting, and in Germany they are often the kind of obligation that runs through DMIDS.

Authorisation is a formal regulatory permission granted by the authority before an activity can take place. For general medical device placement under MDR, Germany does not require pre-market authorisation — conformity assessment plus CE marking plus EUDAMED registration is the route. Clinical investigations are a separate track under MDR Articles 70 to 82 and the MPDG implementing framework, with their own authorisation regime involving BfArM and ethics committees.

Language requirements for the German market

The rule that trips up more founders than any other when entering Germany is language. MDR Annex I Chapter III requires that information supplied with the device — label, instructions for use, safety information, implant card content where applicable — is in a language that can be easily understood by the intended user and, where relevant, in a language determined by the Member State where the device is made available.

Germany requires German. For devices placed on the German market, the label, the IFU, the implant card text where applicable, and safety-relevant information must be available in German. The founder's move is to plan German translation and review by a qualified translator before German launch, not after. A late German translation typically means a relabelling project, stock rework, and a distributor relationship that opens with a corrective action instead of a sale.

Walking through the registration steps for a German-market launch

For a Class IIa or IIb device with a CE certificate in hand and a plan to place the device on the German market, the sequence looks like this at general framing.

First, confirm where the economic operator registration under MDR Article 31 lives. If the manufacturer is established in Germany, the actor registration is verified by BfArM and the SRN is issued in the German EUDAMED context. If the manufacturer is established elsewhere, actor registration is verified by the home Member State's Competent Authority, and the authorised representative (if applicable) is registered in its own Member State. The SRN is a single EU-level number, not a German-specific one.

Second, confirm device registration under MDR Article 29 in EUDAMED, including the Basic UDI-DI and Annex VI Part A data elements. This is an EU-level act, not a German national one, but BfArM as the German Competent Authority sees the German market relevance of the device through the EUDAMED record.

Third, check the current DMIDS position for your specific activity. This is the step that changes over time. Founders should consult BfArM's current DMIDS guidance for their device class and activity type and confirm which national notifications — if any — apply on top of EUDAMED.

Fourth, set up the vigilance routing. Incidents on the German market go to BfArM under MDR Article 87. The internal process should route incident reports automatically based on where the incident occurred, not by ad-hoc decision per case.

Fifth, confirm the language deliverables. German label, German IFU, German implant card text where applicable, and any German-language safety communication material required by distributor or hospital customers. Plan this before the first German shipment.

The Subtract to Ship approach

The Subtract to Ship rule for BfArM and DMIDS is the same rule that applies to every national Competent Authority layer. Do the MDR Article 31 EUDAMED work cleanly — actor registration, PRRC under MDR Article 15, authorised representative where applicable, SRN issued and current, Article 29 device registration complete. That is the fixed EU-level foundation. Then, for Germany specifically, check the current BfArM and DMIDS position for your device class, confirm German language obligations on label and IFU, and set up vigilance routing so incidents on the German market reach BfArM within MDR Article 87 timelines.

Everything else — speculative "German registration consultancy" sold as a separate engagement, elaborate DMIDS dossiers that duplicate EUDAMED data without a specific MPDG basis, bespoke German-specific quality documentation that is not required by MDR or by current BfArM guidance — gets subtracted until a specific MDR article or a current, verified MPDG provision justifies it. See the DMIDS portal and the German medical device information system for the deeper walkthrough of DMIDS itself and national registration requirements alongside EUDAMED for the cross-Member-State framing.

Common mistakes

  • Assuming EUDAMED replaces all German national obligations today. MDR Article 34 governs the transition module by module; MPDG duties continue in parallel where the corresponding EUDAMED module is not yet mandatory.
  • Treating BfArM as an optional database endpoint rather than as an active federal Competent Authority with vigilance, surveillance, and enforcement authority over your device on the German market.
  • Launching in Germany without German-language labelling and IFU, then discovering the gap when a German hospital procurement team asks for the German documentation.
  • Skipping the DMIDS step because a peer company "does not use it" — DMIDS obligations are activity- and device-specific under MPDG and peer anecdotes are not a compliance defence.
  • Confusing the BfArM role for medical devices with its parallel role for medicinal products. BfArM handles both, but the processes, legal bases, and portals are different.

Reality Check — Where do you stand on BfArM registration?

  1. Do you know which Competent Authority verified or will verify your economic operator registration under MDR Article 31, and whether that Competent Authority is BfArM or another Member State's authority?
  2. Have you checked the current BfArM and DMIDS position on national notification for your specific device class and activity, rather than assuming EUDAMED is sufficient?
  3. Is your label, IFU, and (where applicable) implant card text available in German before you place the device on the German market?
  4. Do you have a vigilance routing process that sends serious incidents on the German market to BfArM within the MDR Article 87 timelines?
  5. Is your PRRC under MDR Article 15 correctly named on the data that BfArM will see through EUDAMED and DMIDS?
  6. If BfArM or a Länder market surveillance authority inspected your German distributor tomorrow, would the technical documentation, labels, and vigilance records match the EUDAMED record?
  7. If a German hospital procurement team asked you "what is your German registration number," could you answer the question clearly and show the underlying EUDAMED SRN and any applicable DMIDS record?

If more than two of these are unanswered, Germany is not yet a market you are ready to place a device on — it is a market you have a plan to enter.

Frequently Asked Questions

What is BfArM? BfArM is the Bundesinstitut für Arzneimittel und Medizinprodukte, Germany's federal higher authority for medicinal products and medical devices. For medical devices under MDR and the German MPDG, BfArM handles vigilance, market surveillance at federal level, national notifications through DMIDS, and coordinates with the Länder market surveillance authorities and ethics committees on clinical investigations.

Do I need to register with BfArM if I already registered in EUDAMED? Economic operator registration under MDR Article 31 routes through EUDAMED and is verified by the Competent Authority of the Member State where the operator is established. Whether an additional German national notification through DMIDS applies depends on your specific activity and device class under the MPDG. Check the current BfArM guidance for your device class before launching in Germany.

What is DMIDS and is it the same as EUDAMED? DMIDS is the Deutsches Medizinprodukteinformations- und Datenbanksystem — the German national medical device information system administered under the MPDG. It is not the same as EUDAMED. EUDAMED is the EU-level database under MDR Article 33, while DMIDS is the German national layer that continues to operate alongside EUDAMED until the relevant EUDAMED modules are fully mandatory under MDR Article 34.

Is German translation of the label and IFU mandatory? For devices placed on the German market, user-facing material — label, IFU, patient-facing safety information, implant card content where applicable — must be available in German. This follows from MDR Annex I Chapter III and the German application of that requirement under the MPDG. Plan German translation before German launch, not after.

Does BfArM authorise my device before I can sell it in Germany? No. Under MDR and MPDG, the route to the German market is conformity assessment, CE marking, and EUDAMED registration — not pre-market authorisation by BfArM. Clinical investigations are a separate track with their own authorisation regime under MDR Articles 70 to 82 and the MPDG implementing framework.

Where do I report a serious incident that happens in Germany? To BfArM, as the federal Competent Authority of the Member State where the incident occurred, under MDR Articles 87 to 92 and the MPDG vigilance provisions. Once the EUDAMED vigilance module is fully mandatory, reports flow through that module, but BfArM remains the receiving authority for the German market.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10 (general obligations of manufacturers), Article 15 (Person Responsible for Regulatory Compliance), 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), Articles 87-92 (vigilance), Articles 93-100 (market surveillance), Annex I Chapter III (labelling and instructions for use, including 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. Medizinprodukterecht-Durchführungsgesetz (MPDG) — the German federal law implementing Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Readers should consult the current consolidated version published by the German Federal Ministry of Justice for the live text of national notification, language, vigilance, and enforcement provisions applicable to their specific device class and activity.
  4. BfArM — Bundesinstitut für Arzneimittel und Medizinprodukte, official guidance on medical devices placed on the German market and on the DMIDS portal. Readers should consult BfArM's current published guidance directly for the live status of German national notification obligations, DMIDS user procedures, language requirements, and vigilance contact procedures for their specific device class before acting. The German national framework evolves alongside the EUDAMED transition under MDR Article 34 and the current-terms position should be verified case by case.

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 German national framework is the kind of topic that ages quickly — the MDR article anchors are stable, but the specific DMIDS and BfArM position for any given device class and activity should be verified against current BfArM and MPDG guidance before launch.