DMIDS — the Deutsches Medizinprodukteinformations- und Datenbanksystem — is Germany's national medical device information system, operated under the Medizinprodukterecht-Durchführungsgesetz (MPDG), the German law that implements MDR (EU) 2017/745 at national level. . For startups selling medical devices into Germany, the EU-level obligations under MDR Article 31 (economic operator registration) and Article 29 (device registration) run through EUDAMED. National German notification duties under the MPDG run through DMIDS in parallel, for as long as the relevant EUDAMED modules are not yet fully mandatory under MDR Article 34. Treat DMIDS as the German national layer that sits alongside — not instead of — your EUDAMED obligations.

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

TL;DR

  • DMIDS is the German national medical device information system administered under the MPDG, the German national law implementing the MDR. .
  • MDR Article 31 economic operator registration is an EU-level obligation and routes through EUDAMED, verified by the Competent Authority of the Member State of establishment — BfArM for manufacturers established in Germany.
  • German national notification duties under the MPDG continue to run through DMIDS in parallel with EUDAMED, for as long as the relevant EUDAMED modules are not yet fully mandatory under MDR Article 34.
  • A non-German manufacturer selling into Germany does not usually perform its Article 31 economic operator registration with BfArM, but still becomes a counterparty to BfArM for vigilance, market surveillance, and — where applicable — German-language labelling.
  • The Subtract to Ship rule: do the MDR Article 31 EUDAMED work cleanly, then verify the current DMIDS and MPDG notification position for your specific device class against BfArM's live guidance, not against a blog post.

A founder asks whether "registering with BfArM" is still a thing

One of the most common German-market questions we get from founders outside Germany sounds like this: "Our distributor says we need to register with BfArM. Our German-speaking lawyer said something about DMIDS. Our consultant said EUDAMED handles it. Who is right?"

The honest answer, like in France with ANSM, is that more than one of these can be right at the same time. Germany has an EU layer — the MDR, directly applicable, with registrations routed through EUDAMED — and a national layer — the Medizinprodukterecht-Durchführungsgesetz (MPDG) and the associated DMIDS database. The two layers were designed to interlock. What a founder actually owes depends on which layer each specific obligation sits on, and on how far the EUDAMED transition under MDR Article 34 has progressed on the date they act.

What DMIDS is, at general framing

DMIDS stands for Deutsches Medizinprodukteinformations- und Datenbanksystem — literally, the German Medical Device Information and Database System. . DMIDS is the national database Germany maintains for medical device–related information alongside the EU-level EUDAMED system.

It is important to understand what DMIDS is not. DMIDS is not a substitute for CE marking, not a substitute for conformity assessment, not a substitute for EUDAMED registration under MDR Article 31, and not a pre-market authorisation scheme. Germany, like every EU Member State, places medical devices on the market under the MDR — conformity assessment, CE marking, and EUDAMED registration. DMIDS exists to administer the specific national-layer duties that the MPDG places on economic operators for the German market in addition to the EU-level duties of the MDR.

Historically, Germany's national medical device database was operated under the DIMDI system (Deutsches Institut für Medizinische Dokumentation und Information). DIMDI's medical-devices functions were transferred to BfArM, the Bundesinstitut für Arzneimittel und Medizinprodukte, and BfArM is today the federal authority that operates Germany's medical device information system. .

The MPDG as the German national anchor

The German national law that implements the MDR is the Medizinprodukterecht-Durchführungsgesetz, usually abbreviated MPDG. The MPDG replaced the previous Medizinproduktegesetz (MPG) when the MDR became applicable. .

The MPDG is the national anchor that founders selling into Germany need to know exists, even if they never read the full text themselves. It is the law that:

  • Designates BfArM and the Länder authorities as the Competent Authorities for medical devices in Germany.
  • Establishes national offences and penalties for non-compliance with the MDR and the MPDG
  • Governs national notification duties that sit alongside EUDAMED, including duties currently routed through DMIDS
  • Governs clinical investigations in Germany in conjunction with MDR Articles 62-82

For a non-German founder, the takeaway is not "read the MPDG cover-to-cover." It is "accept that an MPDG layer exists, and check with a German-qualified regulatory contact or BfArM's published guidance which specific MPDG duties apply to your device on the German market, beyond MDR obligations."

Who has to do what with DMIDS

A clean way to hold the picture is to separate operators by establishment.

Manufacturers established in Germany. Your economic operator registration under MDR Article 31 is verified by BfArM as the Competent Authority of your Member State of establishment, and the data routes through EUDAMED. DMIDS comes in for any additional German national notification duties under the MPDG that apply to your device class or activity. .

Manufacturers established outside Germany, selling into Germany. Your Article 31 actor registration is done in your own Member State (or via an authorised representative established in the EU), not with BfArM. You still become relevant to BfArM and, where applicable, DMIDS, because:

  • Serious incidents that occur on the German market are reported to BfArM under MDR Articles 87-92
  • BfArM can exercise market surveillance over your device, your authorised representative, your importer, and your distributors on the German market under MDR Articles 93-100
  • Any specific German national notification duty that is tied to placing a device on the German market — rather than to the establishment of the operator — can apply regardless of where your company is registered in EUDAMED

German authorised representatives and importers. Where a non-EU manufacturer uses a German authorised representative or imports into Germany, those German-established operators have their own MDR Article 31 actor registration duties verified by BfArM, and their own MPDG duties that may route through DMIDS. .

Relationship to EUDAMED

DMIDS and EUDAMED coexist by design for the transition period. The direction of travel under MDR Article 34 is that EUDAMED becomes the single EU register for economic operators, devices, certificates, clinical investigations, vigilance, and market surveillance. As each EUDAMED module becomes fully functional and mandatory by Commission decision under Article 34, the corresponding national-layer duties either rationalise into EUDAMED or remain only as specifically German duties under the MPDG.

The rule a founder should carry is simple. EU-level MDR obligations always run through EUDAMED in the final state and already route through EUDAMED for modules that are live. German-specific MPDG obligations that have no EU equivalent remain in DMIDS regardless of EUDAMED progress. German obligations that do have an EU equivalent but where the corresponding EUDAMED module is not yet mandatory continue to run through DMIDS for now. .

The practical consequence: do not assume EUDAMED registration alone satisfies every German duty today, and do not assume a legacy DIMDI-era national notification procedure is still the correct channel either. Check the current BfArM guidance on DMIDS for your specific device class before acting.

A worked German launch

A Class IIa digital-health device from a startup established in Austria. The company did its MDR Article 31 economic operator registration through BASG (the Austrian Competent Authority), obtained an SRN, registered the device as a Basic UDI-DI under MDR Article 29, and carried the CE mark after conformity assessment by a Notified Body. First EU market was Austria, second was Germany.

For the German launch, the company did four things on top of its EU-level registration.

First, it confirmed — through its German-qualified regulatory contact — which MPDG-specific notification duties applied to its Class IIa digital-health device on the German market, and whether any of those duties routed through DMIDS. .

Second, it prepared German-language labelling and instructions for use. Under MDR Annex I Chapter III, the Member State of sale determines the required language for user-facing material, and Germany requires German for devices made available to users on the German market. .

Third, it set up a vigilance routing rule: any serious incident occurring on the German market goes to BfArM under MDR Articles 87-92, within the MDR timelines, in addition to being recorded in the company's internal vigilance system for later EUDAMED submission.

Fourth, it aligned its EUDAMED actor data with whatever DMIDS-visible data BfArM would see for the German-market activity, so that the company name, address, SRN, PRRC under MDR Article 15, and Basic UDI-DI matched across every register and every label.

Nothing in this list is heroic. It is a disciplined national-layer checklist, run once per new Member State.

The Subtract to Ship registration playbook for Germany

The subtract-to-ship rule for the German national layer is the same structural rule that applies to France, Italy, Spain, Austria, and every other Member State you will sell into. You do the fixed EU-level work cleanly and you do exactly the national-layer work that is actually required, and nothing else.

The playbook, in order:

  1. Complete MDR Article 31 economic operator registration through EUDAMED in your own Member State of establishment. Get your SRN. Name your PRRC under MDR Article 15.
  2. Complete MDR Article 29 device registration (Basic UDI-DI) in EUDAMED for every device you will place on the market, before you place it on the market.
  3. For Germany specifically, check BfArM's current published guidance on DMIDS and the MPDG for your device class. Identify any German national notification duty that applies to your device and your role (manufacturer, authorised representative, importer, distributor).
  4. Complete the German national notification through DMIDS, where applicable, before placing the device on the German market. .
  5. Prepare German-language labelling, IFU, and — where applicable — implant card text under MDR Annex I Chapter III plus the German national language application.
  6. Set up a vigilance routing rule that sends serious incidents occurring on the German market to BfArM within MDR Article 87 timelines.
  7. Align every register, label, and contract on a single source of truth for company name, address, SRN, PRRC, authorised representative, Basic UDI-DI, and device class.

Everything beyond this — bespoke "German quality dossiers" that duplicate EUDAMED data, speculative "DMIDS consultancy" disconnected from a specific MPDG obligation, German-language marketing copy passed off as required regulatory content — gets subtracted until a specific MDR article or a specific, verified MPDG provision justifies it. See the Subtract to Ship framework for MDR for the underlying methodology.

Reality Check — Where do you stand on DMIDS and the German layer?

  1. Do you know which Competent Authority verified your economic operator registration under MDR Article 31, and whether that authority is BfArM or another Member State's authority?
  2. Have you checked BfArM's current published guidance on DMIDS and the MPDG for your specific device class, rather than assuming EUDAMED alone is sufficient for Germany?
  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 occurring on the German market to BfArM within the MDR Article 87 timelines?
  5. Is your PRRC under MDR Article 15 correctly named on every data record that BfArM and DMIDS would see?
  6. If BfArM inspected your German distributor tomorrow, would the technical documentation, labels, and vigilance records match the EUDAMED record and any DMIDS entry?
  7. Do you have a named German-qualified regulatory contact — internal or external — who can verify the current MPDG position on the duties that apply to your device?

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 are planning to enter.

Frequently Asked Questions

What is DMIDS? DMIDS is the Deutsches Medizinprodukteinformations- und Datenbanksystem, Germany's national medical device information and database system, operated under the Medizinprodukterecht-Durchführungsgesetz (MPDG) as the national layer that runs alongside the EU-level EUDAMED system. .

Do I need to register with DMIDS if I already registered in EUDAMED? MDR Article 31 economic operator registration routes through EUDAMED and is verified by the Competent Authority of your Member State of establishment. Whether an additional German national notification applies to your device on the German market depends on the current MPDG position and on which EUDAMED modules are mandatory under MDR Article 34. Check BfArM's current DMIDS guidance for your device class before launching in Germany.

Is BfArM the same thing as DMIDS? No. BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is the German federal authority. DMIDS is the database system BfArM operates for medical device–related national information under the MPDG. BfArM is the authority; DMIDS is one of the tools BfArM uses. .

Is German translation of the label and IFU mandatory for the German market? For devices made available to users 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 language rule under the MPDG and general German consumer-health law. Plan German translation before German launch, not after. .

Does BfArM pre-authorise my device before I can sell it in Germany? No. Under the MDR, 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 corresponding MPDG provisions. .

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 the MDR at national level, and the legal basis for DMIDS and for BfArM's role as German Competent Authority. . Readers should consult BfArM's current published guidance directly for the live status of DMIDS notification obligations, the MPDG position for their specific device class, and the current German-language labelling requirements before acting. The German national framework is evolving alongside the EUDAMED transition under MDR Article 34 and the current-terms position should be verified case by case.
  4. BfArM — Bundesinstitut für Arzneimittel und Medizinprodukte, official guidance on medical devices and the German medical device information system. Consult BfArM's current published materials directly for the live DMIDS and MPDG position.

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 MPDG position for any given device class should be verified against current BfArM guidance before launch.