First-in-Human Medical Device Trials in Austria

Austria is a smaller early device market in our data, but most of its work comes from foreign sponsors and multinational programs. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and how Austria compares with Latin America for a United States (US) sponsor.

What the registry shows

Our query of ClinicalTrials.gov (CT.gov) found 33 early-stage, industry-sponsored device studies with at least one site in Austria, first posted between 1 January 2021 and 28 September 2026. That ranks Austria #21 worldwide on this measure. Of these, 18 used FIH, feasibility or pilot language in the title or summary, and 4 explicitly described a first-in-human or early feasibility study. 21 were run by sponsors headquartered outside Austria, 9 of them by US-headquartered companies, and 18 also listed sites in another country. Registrations went from 20 in 2021–2023 to 13 from January 2024 to September 2026.

Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

How authorization works in Austria

Austria applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) through the Medical Devices Act 2021 (Medizinproduktegesetz, MPG 2021). Applications go to the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG).

• Electronic submission only.
• Ethics first: the application must include a final, favourable ethics committee vote. BASG does not accept a preliminary vote, and an application without a final vote will be rejected.
• Validation: within 10 days, BASG confirms the application is valid or sends a deficiency letter. The sponsor has 10 days to respond, or 20 more on justified request, and BASG then completes validation within 5 days.
• Start: investigations under Art. 70(7)(a) MDR (class I and non-invasive class IIa/IIb) may start after BASG confirms validation. Investigations under Art. 70(7)(b), which covers most FIH devices, need a 45-day review, extendable by 20 days for experts.
• Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

Where Austria is strong

• Foreign and multinational use: 21 of 33 early studies came from sponsors headquartered outside Austria, and 18 had sites in other countries.
• Feasibility-oriented: 18 studies (55%) described themselves as FIH, feasibility or pilot studies.
• A clear procedure: BASG publishes step-by-step validation timelines and uses electronic submission only.
• Therapeutic focus: Cardiovascular (13 studies), neurology (5) and respiratory (5) led the mix.

Austria’s numbers are small, so the change between periods (20 to 13) should be read with caution.

Using data from Austria in a US submission

The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

How Latin America compares

Austria requires the final ethics vote before BASG review, and Vienna is six hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

• Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
• Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
• Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
• Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
• Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

When Austria is the better fit: as a site in a multinational European program, or when specific Austrian investigators are central to your device. For a standalone FIH study aimed at FDA, compare a Latin American site on time zone, enrollment and travel.

Frequently asked questions

Do I need ethics approval before applying to BASG?

Yes. The application must include a final, favourable ethics vote. BASG rejects applications with only a preliminary vote.

How long does BASG take?

BASG confirms validity or sends a deficiency letter within 10 days. Class I and non-invasive IIa/IIb investigations may start after validation, and other classes need a 45-day review, plus 20 days if experts are consulted.

Which law governs device investigations in Austria?

The EU MDR, together with the Austrian Medical Devices Act 2021 (MPG 2021).

Can data from an Austrian first-in-human study support an FDA submission?

Yes, if the study meets 21 CFR 812.28 and FDA can validate the data. That makes the data reviewable. It is not clearance or approval.

Next step

Weighing Austria against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

Sources

• BASG, Clinical investigations with medical devices
• BASG, Guidance for submission and conduct of a clinical investigation with medical devices (PDF)
• Regulation (EU) 2017/745 (MDR), Articles 62 and 70
• 21 CFR 812.28, Acceptance of data from clinical investigations conducted outside the United States (eCFR)
• FDA, Acceptance of Data from Clinical Investigations for Medical Devices
• FDA Recognized Consensus Standards database, ISO 14155:2020 (recognition no. 2-282)
• FDA, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• ClinicalTrials.gov API v2 (query run 28 Sep 2026; filter in Method note)