First-in-Human Medical Device Trials in Germany

Germany is one of Europe’s busiest settings for early device studies, much of it for foreign sponsors. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and when a Latin American site is the better first step for a United States (US) company.

What the registry shows

Our query of ClinicalTrials.gov (CT.gov) found 107 early-stage, industry-sponsored device studies with at least one site in Germany, first posted between 1 January 2021 and 28 September 2026. That ranks Germany #9 worldwide on this measure. Of these, 46 used FIH, feasibility or pilot language in the title or summary, and 9 explicitly described a first-in-human or early feasibility study. 72 were run by sponsors headquartered outside Germany, 19 of them by US-headquartered companies, and 40 also listed sites in another country. Registrations went from 59 in 2021–2023 to 48 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 Germany

Germany applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) through the Medical Devices Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG). The steps run in sequence. The sponsor first submits to the competent ethics committee. Only after a favourable opinion does the same application go to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), through the German Medical Devices Information and Database System (DMIDS).

• Class I and non-invasive class IIa devices (Art. 70(7)(a) MDR with §31(1) MPDG) use a shorter procedure. The study may start once the ethics committee has given a favourable opinion and BfArM has raised no objection after validation.
• Invasive class IIa, class IIb and class III devices, which covers most FIH implants, need full authorization under Art. 70(7)(b) MDR and §31(2) MPDG. The MDR allows 45 days from validation, plus 20 days if experts are consulted, and the clock stops while the sponsor answers questions.
• Sponsors based outside the EU must name a legal representative in the EU (Art. 62(2) MDR).

Where Germany is strong

• International demand: 72 of 107 early studies (67%) were run by sponsors headquartered outside Germany, and 40 also had sites in other countries. A sign that sites are used to foreign sponsors.
• Clear rules: statutory MDR clocks and detailed BfArM guidance on DMIDS.
• A route to the EU market: a study authorized under the MDR can feed the clinical evaluation for CE (Conformité Européenne) marking.
• Therapeutic depth: Cardiovascular (26 studies), ear, nose and throat and hearing (15) and oncology (11) led the early-study mix.

Using data from Germany 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

Germany’s sequential model means ethics and regulator reviews add up rather than overlap, and Central European Time 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 Germany is the better fit: if the EU is your first market and you need MDR data early, or your key opinion leaders are German, starting there can save a second study. You can also do both: FIH in Latin America, then a European study once the design settles.

Frequently asked questions

How long does BfArM take to authorize a first-in-human device study?

For invasive class IIa, IIb and III devices, the MDR allows 45 days from validation, extendable by 20 days for expert consultation, with the clock stopped during questions. In Germany the ethics committee reviews first, so total time also depends on the ethics phase.

Does the ethics committee review run in parallel with BfArM in Germany?

No. Germany uses a sequential procedure: the application goes to the ethics committee first and is sent to BfArM through DMIDS only after a favourable opinion.

Does a US company need an EU representative to run a device study in Germany?

Yes. Under Article 62(2) of the MDR, a sponsor not established in the EU must have a legal representative in the EU.

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

It can, if the study meets 21 CFR 812.28: good clinical practice, independent ethics review, informed consent and the required supporting information, with data FDA can validate. That makes the data reviewable. It is not clearance or approval.

Next step

Weighing Germany 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

• BfArM, Request for authorisation of a clinical investigation
• BfArM, DMIDS guidance for sponsors (PDF)
• BfArM, DMIDS overview
• 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)