What regulatory authority approves medical devices in Austria?

The Bundesamt für Sicherheit im Gesundheitswesen (BASG) — Federal Office for Safety in Health Care — is Austria's national competent authority for medical devices. BASG operates under AGES (Österreichische Agentur für Gesundheit und Ernährungssicherheit). As a full EU member state, Austria applies EU MDR (2017/745) completely. CE marking valid in the EU is valid in Austria without any separate Austrian registration — BASG receives vigilance reports and conducts market surveillance but does not issue separate national market approvals.

What is Bundesbeschaffung GmbH (BBG) and how does it affect medical device procurement?

Bundesbeschaffung GmbH (BBG) is Austria's Federal Procurement Agency, 100% owned by the Republic of Austria. BBG establishes framework agreements (Rahmenverträge) for federal entities, including federal hospitals. When a medical device category is covered by a BBG framework agreement, federal hospital buyers can purchase from framework suppliers without running their own open tenders — significantly accelerating procurement for buyers and providing guaranteed revenue for admitted suppliers. Being admitted to a BBG framework agreement for your device category is commercially significant for accessing federal procurement without competing in individual hospital tenders.

How do public hospital tenders work in Austria's federal structure?

Austria has a dual-level hospital procurement structure. Federal procurement is managed by BBG using framework agreements, with tender notices on Bieterportal.at. State-level (Länder) procurement is managed independently by each of Austria's nine state hospital networks — including Gesundheitsverbund Wien (Vienna), Kages (Styria), TILAK (Tyrol), SALK (Salzburg), and KUK (Upper Austria). Each state network runs its own procurement process, publishes tenders on Bieterportal.at or state-specific portals, and maintains its own framework agreements for commonly purchased device categories. There is no single national hospital framework equivalent to the UK NHS Supply Chain — state networks must be addressed individually.

What language is required for Austrian medical device tender submissions?

German is required for Austrian public tender submissions, including tender responses, technical documentation, IFU, and product labelling. This is consistent with German-market MDR documentation requirements — German-language compliance materials designed for the German (DE) market generally satisfy Austrian requirements. English-only submissions are typically rejected at the administrative compliance stage of Austrian public procurement. Bilingual German-English documentation is acceptable for most technical annexes.

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Medical Device Tenders in Austria: Manufacturer Bid Guide [2026]

2026年7月6日

Austria is a high-income EU member state with a well-funded public healthcare system and a medical device market estimated at €1.0–1.2 billion annually. As a full EU member, Austria applies EU MDR (2017/745) completely — CE-marked devices valid across the EU are valid in Austria without separate registration. What distinguishes Austrian procurement from other major EU markets is its dual structure: federal procurement managed by Bundesbeschaffung GmbH (BBG) through framework agreements, and state-level procurement by nine Länder (federal states), each with distinct hospital networks and independent procurement authorities. Understanding how BBG framework access interacts with state-level procurement is the key to building efficient Austrian market coverage.

Regulatory authority and approval pathway

The Bundesamt für Sicherheit im Gesundheitswesen (BASG) — Federal Office for Safety in Health Care — is Austria's national competent authority for medical devices. BASG operates under AGES (Österreichische Agentur für Gesundheit und Ernährungssicherheit), the Austrian Agency for Health and Food Safety (basg.gv.at).

Device classification: Austria applies EU MDR risk classification directly — Class I, Class IIa, Class IIb, and Class III. IVDR (2017/746) classification and timelines apply to in vitro diagnostic devices.
CE marking: EU CE marking under MDR (or valid MDD legacy certificates within applicable transition periods) is directly valid in Austria. BASG does not issue separate Austrian market approvals — it conducts market surveillance and receives vigilance reports. For suppliers already holding EU MDR conformity, Austrian market access is automatic.
EUDAMED: Austria participates fully in EUDAMED. Economic operators with devices placed on the Austrian market must complete EUDAMED actor, device, and UDI registration in line with EU MDR phase-in timelines. BASG is the Austrian competent authority in EUDAMED.
EU Authorised Representative: Foreign manufacturers without EU/EEA presence require an EU/EEA Authorised Representative under EU MDR. That representative's contact details must appear on device labelling and in EUDAMED — no additional Austrian-specific AR appointment is required beyond MDR requirements.
Notified Bodies: TÜV Austria GmbH and OFI (Österreichisches Forschungsinstitut) are the primary Austrian-based Notified Bodies designated under EU MDR. Certificates from any EU-designated Notified Body are valid in Austria — no Austrian NB certificate is specifically required.
German-language labelling: Austrian labelling and IFU must be in German (or German-English bilingual). German-language compliance materials prepared for the German (DE) market generally satisfy Austrian requirements, though the distributor's Austrian address should be reflected where applicable. German-language labelling is a legal requirement, not a preference.
Vigilance reporting: Serious incidents and field safety corrective actions affecting the Austrian market are reported to BASG, in parallel with EUDAMED reporting. BASG coordinates with EU competent authorities through EUDAMED and standard competent authority communication channels.

Key procurement platforms and channels

Bieterportal.at: Austria's central national public procurement portal, operated by BBG. All public tenders above EU thresholds (approximately €140,000 for goods and services for central government authorities; €215,000 for other public authorities) must be published on TED (Tenders Electronic Daily) and typically also on Bieterportal. Many state and municipal tenders are also published on Bieterportal regardless of value. Bieterportal is the starting point for systematic Austrian tender monitoring.
Bundesbeschaffung GmbH (BBG): The Federal Procurement Agency, 100% owned by the Republic of Austria. BBG establishes multi-year framework agreements (Rahmenverträge) for federal entities — including federal ministries, federal hospitals, and other central government bodies — covering commonly procured goods and services. BBG framework tenders are competitive and published on Bieterportal. Once admitted, framework suppliers can receive orders from any entitled federal buyer without further competitive tendering. For medical devices procured by federal entities, BBG framework access is the primary commercial channel.
State hospital networks (Länder): Austria's nine Länder each operate their own hospital networks with independent procurement authorities. Major networks include:
- Gesundheitsverbund Wien (Vienna Health Association, formerly KAV) — the largest, operating approximately 20 hospitals with over 10,000 beds across Vienna
- Kages (Steiermärkische Krankenanstaltengesellschaft) — Styria's hospital network, including the LKH Graz University Hospital
- TILAK (Tiroler Landeskrankenanstalten GmbH) — Tyrol's network, including the Medical University of Innsbruck hospital
- SALK (Salzburger Landeskliniken) — Salzburg's network, including the Uniklinikum Salzburg
- KUK (Kepler Universitätsklinikum) — the major academic hospital in Linz, Upper Austria
- NÖ Landesgesundheitsagentur (Lower Austria), Gespag (Upper Austria regional hospitals), and Krankenanstaltenverbund Burgenland
Each network runs its own procurement processes, publishes tenders on Bieterportal or state-specific e-procurement portals, and maintains its own framework agreements for device categories.
University hospitals: AKH Wien (Allgemeines Krankenhaus Wien, affiliated with MedUni Wien), the university hospitals in Graz (LKH-Univ. Klinikum Graz), Innsbruck (Universitätsklinikum Innsbruck), and Salzburg conduct their own procurement for research equipment, advanced medical technology, and specialised devices. University hospital procurement follows the standard Austrian public procurement law but often includes additional evaluation criteria reflecting clinical research and teaching requirements.
Outpatient and reimbursement channel: Österreichische Gesundheitskasse (ÖGK) — the unified social health insurance fund — manages the Erstattungskodex (EKO) reimbursement list for outpatient medical devices. For devices used in ambulatory, home care, or pharmacy-dispensed contexts (wound care, incontinence aids, orthoses, CPAP, blood glucose monitoring), ÖGK EKO listing is the commercial gateway, separate from hospital tender processes.

Compliance requirements for public tenders

Valid CE marking under MDR: The fundamental eligibility requirement. Certificates must be current and correspond to the exact device models in the tender submission. EUDAMED registration confirmation is increasingly requested in Austrian public procurement qualification envelopes, particularly for Gesundheitsverbund Wien and Kages tenders.
ISO 13485:2016: QMS certification is expected across all device classes above Class I in Austrian hospital tenders. TÜV Austria-issued certificates carry particular recognition with Austrian procurement teams, though certificates from any accredited certification body are accepted.
German-language tender submissions: Austrian public procurement law (Bundesvergabegesetz 2018 — BVergG 2018) and standard Austrian tender conditions require German-language submissions. Technical annexes (IFU, specifications) in German-English bilingual format are generally acceptable; English-only submissions are typically rejected at the administrative compliance check.
BVergG 2018 exclusion grounds: Bidders must confirm they are not excluded under §68 BVergG 2018 — grounds include insolvency, criminal convictions for specific offences, serious professional misconduct, tax and social contribution irregularities, and breaches of environmental or social law. Foreign companies provide equivalent documentation from their home country (court clearance certificate, tax compliance declaration).
Austrian organisational number: Companies trading in Austria for VAT purposes require an Austrian UID number (Umsatzsteuer-Identifikationsnummer) from Finanz Austria. This is a practical prerequisite for invoicing Austrian hospital procurement organisations.
Reference installations: Austrian hospital tenders routinely request documented reference installations at comparable hospitals, with named contact persons for verification. Austrian or German-speaking country references (Germany, Switzerland) carry the most weight. Academic hospital references (AKH Wien, LKH Graz) are particularly valued for clinical device categories.
Service capacity: Austrian public tenders require evidence of service infrastructure within Austria or with demonstrated next-day access from a German or Swiss service base. Response time SLAs for critical equipment (typically 4–8 hours for clinical critical devices) are standard in hospital tender requirements. Austrian-based or German-speaking service engineers are expected.
BBG framework terms compliance: Admission to a BBG framework agreement brings ongoing compliance obligations — maximum pricing, delivery timelines, reporting requirements, and framework-level auditing. BBG framework compliance is monitored and non-compliant suppliers can be removed from active frameworks.

Market structure and opportunity

Public hospital dominance: Approximately 70–75% of Austrian hospital beds are in publicly funded hospitals (state-owned or social insurance hospitals). The nine Länder networks are the primary buyers in the Austrian medical device market. Understanding each network's procurement calendar and decision-making structure is essential for systematic coverage.
Private hospitals: Private hospital chains — Vinzenz Gruppe, Premiqamed, Vamed, and Oberösterreichische Gesundheitsholding — operate alongside state networks. Private hospital procurement follows internal company purchasing procedures, without BVergG public procurement obligations, and typically moves faster than public procurement with more discretionary buyer authority. Private hospitals are often good first reference sites for new technologies.
ELGA integration: Austria's electronic health record system (ELGA — Elektronische Gesundheitsakte) is an increasingly relevant procurement consideration. Devices that integrate with ELGA data exchange standards are preferred in digital procurement specifications. Suppliers should understand ELGA HL7 CDA standards and their device's ELGA integration capability.
Aging population demographics: Austria's aging population is driving growth in geriatric care equipment, orthopaedic implants, cardiology devices, home monitoring, and minimally invasive surgery. Municipal-funded geriatric care procurement is a growing secondary market alongside hospital procurement.
Medical tourism and private clinic segment: Austria is a significant medical tourism destination (particularly for dental, orthopaedic, and cosmetic procedures), supporting a premium private clinic segment that procures advanced diagnostic and therapeutic equipment outside the state procurement system.

Common challenges for foreign suppliers

Fragmented state procurement: Nine Länder hospital networks, each with its own procurement authority, tender calendar, and evaluation culture, require significant monitoring and relationship-building effort across multiple organisations simultaneously. Unlike the UK NHS Supply Chain or Norway's Sykehusinnkjøp HF, there is no single national hospital procurement framework covering all Austrian public hospitals — only BBG for the federal subset. Suppliers must maintain parallel relationships with each major state network.
BBG framework admission complexity: BBG framework tenders are competitive multi-round processes. Admission to a BBG framework for your device category is commercially significant but requires investment in bid preparation, compliance documentation, and framework management. Framework tenders can be extensive, and unsuccessful applications mean waiting for the next renewal cycle.
German-language documentation burden: Austrian tenders require full German-language submissions. For companies whose primary MDR documentation and product literature is in English, German translation of IFU, technical specifications, and tender responses adds cost and lead time — particularly when maintaining consistency with CE marking documentation.
Local service SLA requirements: Austrian hospitals expect local service infrastructure. German-based service operations can often satisfy Austrian response time SLAs, but more distant service centres create competitive disadvantage. Companies without German-speaking service networks face qualification risk on service requirements in state hospital tenders.

Tips for foreign suppliers