Austria's Bundesamt fuer Sicherheit im Gesundheitswesen (BASG), operated through the Austrian Agency for Health and Food Safety (AGES), is the Competent Authority for medical devices placed on the Austrian market. Under MDR Article 31, manufacturers, authorised representatives, and importers register as economic operators through EUDAMED, and the Competent Authority of the Member State where the operator is established — BASG for Austria — verifies that data and issues the Single Registration Number. Alongside the EUDAMED path, the Austrian Medizinproduktegesetz (MPG) implements national duties that BASG/AGES administers, including market surveillance and vigilance. Until the relevant EUDAMED modules are fully mandatory under MDR Article 34, Austrian national obligations continue in parallel, and Austrian-based founders should treat BASG as their primary regulatory counterpart, not just a database endpoint.

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

TL;DR

  • BASG is Austria's Competent Authority for medical devices; AGES is the agency that operationally hosts BASG's medical device work.
  • MDR Article 31 is the legal anchor for economic operator registration; it routes through EUDAMED, with verification by the Competent Authority of establishment — BASG for Austrian operators.
  • The Austrian Medizinproduktegesetz (MPG) is the national law that implements MDR duties and additional Austria-specific obligations.
  • For an Austrian-established manufacturer, BASG verifies your actor data and is your day-to-day regulatory counterpart on vigilance, market surveillance, and any residual national notification.
  • The Subtract to Ship rule: do the MDR Article 31 EUDAMED work cleanly, register with BASG through the Austrian e-government channel, and verify the current BASG position for your specific device class instead of importing a German or French playbook.

Why Austria is the natural starting point for Austrian founders

Austria is a small country that produces a disproportionate amount of MedTech. Graz alone — where this co-author is based — hosts a medical university, a technical university, and a cluster of device and digital-health startups that have collectively built several hundred million euros of enterprise value in the last decade. The practical question for every Austrian-founded MedTech company is the same: "We are here, we have a device, we want to register and start selling. Who do we talk to, and in what order?"

The short answer is BASG, through AGES, under the Austrian Medizinproduktegesetz and the directly applicable MDR. The longer answer is the rest of this post.

A founder I worked with in Graz last year put it exactly right when they asked: "Is BASG the same as AGES, or are they different?" They are not the same, and the distinction matters for any form, letter, or portal a founder is about to fill in.

BASG and AGES: what the two names actually mean

BASG — the Bundesamt fuer Sicherheit im Gesundheitswesen, or Federal Office for Safety in Health Care — is the legal Competent Authority. It is the body with regulatory decision-making power for medicinal products, medical devices, and related health products in Austria. When the MDR refers to "the Competent Authority of the Member State," for Austria that means BASG.

AGES — the Oesterreichische Agentur fuer Gesundheit und Ernaehrungssicherheit, or Austrian Agency for Health and Food Safety — is the agency that operationally hosts and runs BASG's work. In practice, the medical device team you deal with, the inspectors you meet, the case handlers who process your submissions, and the scientific staff who assess files are AGES employees carrying out BASG's statutory functions.

For a founder, the rule of thumb is: the legal decision is BASG's, the operational counterpart is AGES. Correspondence often arrives on AGES letterhead with BASG as the issuing authority. The e-government portal that handles device notifications is operated by AGES on behalf of BASG.

The Austrian registration framework at general level

Austria's medical device regulatory architecture, like every other Member State's, has two layers that a founder has to hold in their head simultaneously.

The first layer is the EU-level MDR framework. Regulation (EU) 2017/745 is directly applicable in Austria, as it is in every Member State. Economic operators register under MDR Article 31, devices under MDR Article 29, and both registrations route through EUDAMED under MDR Article 33. The Competent Authority of the Member State where the economic operator is established verifies the actor data and issues the Single Registration Number. For a manufacturer established in Austria, that Competent Authority is BASG.

The second layer is the Austrian national framework, anchored in the Medizinproduktegesetz. The original MPG dates back to the 1990s and implemented the old Medical Devices Directives in Austrian law. When the MDR became applicable in May 2021, Austria replaced the legacy MPG with a new national law — commonly referred to as the MPG 2021 — that implements the MDR into Austrian law, designates BASG as the Competent Authority, sets penalties for non-compliance, and handles topics the MDR leaves to Member State discretion such as language, reprocessing of single-use devices, and in-house manufacturing by health institutions.

The practical rule for this post: the EU-level obligations under MDR Article 31 are fixed and can be stated with precision. The specific Austrian national notification duties and their current format sit inside the MPG 2021 and implementing ordinances, which founders should verify against current BASG guidance before acting rather than rely on a static blog description.

What BASG requires beyond EUDAMED

Even when a manufacturer's EUDAMED actor and device registration is clean, BASG remains an active regulatory counterpart for devices on the Austrian market. Three 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 an Austrian hospital, the report goes to BASG — regardless of where your company is registered in EUDAMED. BASG operates a dedicated medical device vigilance function staffed by AGES personnel, and it is one of the more accessible national authorities in the EU for Austrian-based founders: the case handlers will take a phone call and walk a first-time reporter through the process. That accessibility is worth something.

Market surveillance. Under MDR Articles 93 to 100, BASG can inspect manufacturers, authorised representatives, importers, and distributors active on the Austrian market. That includes requesting technical documentation, demanding samples, and taking enforcement action where non-compliance is found. Austrian startups often meet BASG for the first time not through a registration process but through a targeted market surveillance inquiry — a fact the Subtract to Ship approach takes seriously.

Residual national notification duties. The MPG 2021 carries forward certain national notification obligations that sit alongside EUDAMED while specific EUDAMED modules remain in transition under MDR Article 34. The general framing founders should carry is: "There may be an Austrian-specific notification on top of EUDAMED for my device class — I will check the current BASG guidance before I place the device on the Austrian market."

The Austrian PRRC and the MPG language rule

Two specific Austrian touches deserve their own paragraphs because they show up in almost every file BASG handles.

The PRRC under MDR Article 15. Every manufacturer must have a Person Responsible for Regulatory Compliance. For a micro-enterprise the PRRC may be a contracted external, and for Austrian startups this is often how the early-stage setup works. BASG and AGES case handlers know the Austrian regulatory affairs market well and will notice if the named PRRC on your EUDAMED actor record is someone who is also the PRRC for twelve other companies on incompatible timelines. Name a PRRC who can actually do the job.

Language. MDR Annex I Chapter III requires that information supplied with the device is in a language determined by the Member State where the device is made available. Austria requires German for user-facing material placed on the Austrian market — label, IFU, patient-facing safety information, implant card text where applicable. German-language IFU is non-negotiable for consumer or patient-facing devices. Professional-use device IFUs in some contexts allow English in specific sections, but the default assumption for an Austrian launch is German.

Austrian-based founders often get an unexpected advantage here: their team already speaks German, and the original device documentation was often drafted in German before being translated to English for the EU-wide technical documentation. Use that. Do not pay twice for translation of your own language.

A worked Austrian launch

A Graz-based digital-health startup I worked with last year went through the BASG registration path more or less cleanly, and the sequence is worth writing down because it maps to what most Austrian founders will do.

Step one was the conformity assessment path under MDR — in their case, Class IIa software under Annex VIII Rule 11, Notified Body route, technical documentation review. That work is not Austrian-specific; it is MDR work that would be the same in any Member State.

Step two was setting up the economic operator actor record under MDR Article 31 and submitting it through the Austrian channel for BASG verification. BASG issued the Single Registration Number and the company was then a properly registered economic operator visible in EUDAMED.

Step three was the device-level UDI-DI and Basic UDI-DI registration under MDR Article 29, again routed through EUDAMED.

Step four was the Austrian layer: they confirmed the current BASG position on any residual national notification for their device class, checked the German-language IFU and label with an Austrian-based reviewer (not just a German national one — the vocabulary differs in places), named their PRRC cleanly, and put a vigilance routing process in place so any serious incident occurring in Austria would be reported to BASG within MDR Article 87 timelines.

The whole Austrian-specific part of the launch — the work that would not have been required if they were selling only outside Austria — was maybe two weeks of elapsed time and a modest invoice from their regulatory consultant. It was not the expensive part of the MDR journey. The expensive part was steps one through three, which are EU-level MDR work.

That ratio is the Subtract to Ship lesson in a single paragraph: the national layer is real, but it is small relative to the MDR core. Treat it accordingly.

The Austrian founder's checklist

When an Austrian founder asks "what do I actually have to do for BASG," this is the list.

  1. Confirm your device is a medical device under MDR Article 2(1) and classify it under MDR Annex VIII.
  2. Complete conformity assessment on the correct MDR route for your class. This is the large work; BASG does not substitute for it.
  3. Establish a compliant QMS under MDR Article 10(9) and EN ISO 13485:2016+A11:2021.
  4. Name a PRRC under MDR Article 15 and confirm the PRRC is real, available, and qualified.
  5. Register as an economic operator under MDR Article 31 via the Austrian channel so BASG verifies your actor data and issues your SRN.
  6. Register your devices under MDR Article 29 with Basic UDI-DI and UDI-DI data.
  7. Check the current BASG guidance on any residual Austrian national notification for your specific device class.
  8. Produce German-language label, IFU, and implant card content (where applicable) before placing the device on the Austrian market.
  9. Put a vigilance routing process in place so serious incidents occurring in Austria reach BASG within MDR Article 87 timelines.
  10. Put a calendar reminder to re-check BASG guidance and your EUDAMED actor data quarterly — both evolve.

That is the list. It is not short, but it is finite and every item traces back to a specific MDR article or a specific current Austrian requirement.

Common mistakes

  • Confusing BASG and AGES and misaddressing correspondence. The legal authority is BASG; AGES is the agency that operationally runs the work.
  • Assuming EUDAMED replaces all MPG obligations today. MDR Article 34 governs the transition module by module; Austrian national duties continue in parallel where the corresponding EUDAMED module is not yet mandatory.
  • Using a German IFU written for the German market without checking Austrian-specific terminology, regulatory references, and any MPG-specific obligations.
  • Naming a PRRC who cannot realistically perform the role — a contracted external stretched across too many clients is a BASG red flag in practice.
  • Registering once and never updating. EUDAMED data and any Austrian national data must be kept current; stale records generate findings.

The Subtract to Ship approach

The Subtract to Ship rule for BASG is the same rule that applies to every national Competent Authority touchpoint. Do the MDR Article 31 EUDAMED work cleanly and completely — actor registration, PRRC under MDR Article 15, authorised representative where applicable, SRN issued and current. That is the fixed EU-level foundation. Then, for Austria specifically, check the current BASG position on national notification under the MPG 2021, confirm German-language obligations on label and IFU, and set up vigilance routing so incidents on the Austrian market reach BASG within MDR Article 87 timelines.

Everything else — speculative "Austrian registration dossiers" sold as a separate engagement, elaborate national files that duplicate EUDAMED data, bespoke MPG-specific quality documentation that is not required by the MDR or by current BASG guidance — gets subtracted until a specific MDR article or a current, verified Austrian national requirement justifies it.

Reality Check — Where do you stand on BASG registration?

  1. Do you know whether BASG is the Competent Authority that will verify your economic operator registration under MDR Article 31 — i.e., is your manufacturer or authorised representative established in Austria?
  2. Have you checked the current BASG position on any residual Austrian national notification for your specific device class under the MPG 2021, 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 Austrian market?
  4. Do you have a vigilance routing process that sends serious incidents on the Austrian market to BASG within the MDR Article 87 timelines?
  5. Is your PRRC under MDR Article 15 correctly named, actually qualified, and not stretched across incompatible client loads?
  6. If BASG/AGES inspected your operations tomorrow, would your technical documentation, German-language user material, and vigilance records match your EUDAMED record exactly?
  7. Do you know the difference between BASG and AGES well enough to address a formal letter to the right addressee?

If more than two of these are unanswered, the Austrian market 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 BASG? BASG is the Bundesamt fuer Sicherheit im Gesundheitswesen, Austria's Federal Office for Safety in Health Care. It is the Competent Authority for medical devices in Austria under the MDR and the Austrian Medizinproduktegesetz. BASG's medical device work is operationally carried out by staff of AGES, the Austrian Agency for Health and Food Safety.

What is the difference between BASG and AGES? BASG is the legal authority with regulatory decision-making power. AGES is the agency that operationally hosts and runs BASG's work. Correspondence and inspections are carried out by AGES personnel acting on behalf of BASG. For a founder, the practical counterpart is AGES; the formal legal authority is BASG.

Do I need to register with BASG if I already registered in EUDAMED? If your company is established in Austria, BASG is the Competent Authority that verifies your MDR Article 31 actor data and issues your Single Registration Number. Whether additional Austrian national notification applies to your specific device class depends on the current MPG 2021 framework and implementing ordinances, which should be checked directly with BASG before launch.

Is a German-language IFU mandatory for the Austrian market? For user-facing material on devices placed on the Austrian market — label, IFU, patient-facing safety information, implant card text where applicable — German is the default language requirement under MDR Annex I Chapter III as applied through the Austrian Medizinproduktegesetz. Professional-use devices may allow English in specific sections, but the default assumption should be German.

Where do I report a serious incident that happens in Austria? To BASG, as the Competent Authority of the Member State where the incident occurred, under MDR Articles 87 to 92. BASG's medical device vigilance function is operated by AGES and is accessible to first-time reporters by phone and email.

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 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), Annex VIII (classification rules). 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. Austrian Medizinproduktegesetz 2021 (MPG 2021), the Austrian national law implementing the MDR and designating BASG as the Competent Authority for medical devices.
  4. BASG/AGES — Bundesamt fuer Sicherheit im Gesundheitswesen, operated through the Austrian Agency for Health and Food Safety (AGES), official published guidance on medical devices placed on the Austrian market. Readers should consult BASG's current published guidance directly for the live status of Austrian national notification obligations, language requirements, and vigilance contact procedures for their specific device class before acting. The Austrian national framework is evolving 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, who is based in Graz and has worked with BASG and AGES across dozens of Austrian MedTech certifications. The Austrian national framework is the kind of topic that ages quickly — the MDR article anchors are stable, but the specific BASG/MPG position for any given device class should be verified against current BASG guidance before launch.