First-in-Human Medical Device Trials in Belgium

Belgium is small, but it runs an unusually high share of true first-in-human work. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and where Latin America fits for United States (US) sponsors.

What the registry shows

Our query of ClinicalTrials.gov (CT.gov) found 77 early-stage, industry-sponsored device studies with at least one site in Belgium, first posted between 1 January 2021 and 28 September 2026. That ranks Belgium #11 worldwide on this measure. Of these, 37 used FIH, feasibility or pilot language in the title or summary, and 12 explicitly described a first-in-human or early feasibility study. 52 were run by sponsors headquartered outside Belgium, 14 of them by US-headquartered companies, and 42 also listed sites in another country. Registrations went from 44 in 2021–2023 to 33 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 Belgium

Belgium applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) through the Law of 22 December 2020 and the Royal Decree of 18 May 2021. The Federal Agency for Medicines and Health Products (FAMHP) runs a single-submission model:

• One dossier, one decision: the sponsor submits once through the Common European Submission Portal (CESP). FAMHP and an ethics committee assess it together and issue one consolidated decision.
• Timeline: FAMHP validates within 10 days, and the acknowledgement of receipt marks day T0. Questions arrive by T28. There is one round of questions, with a clock stop of up to 20 days. The decision comes by T45, or T65 if experts are consulted.
• Every class is assessed: Belgium does not use the shorter notification route the MDR allows for lower-risk devices, so each investigation gets a full assessment.
• Sponsors based outside the EU need a legal representative in the EU (Art. 62(2) MDR).

Where Belgium is strong

• FIH focus: 12 of 77 early studies (16%) were explicitly FIH or EFS, one of the highest shares in Europe in our data.
• Multinational use: 42 studies also had sites in other countries, and 52 came from sponsors headquartered outside Belgium.
• A predictable process: a single portal, a joint ethics and regulatory review, and published day targets (T0, T28, T45).
• Therapeutic depth: Cardiovascular (23 studies), ear, nose and throat and hearing (11) and orthopedic and spine (9) led the mix.

Using data from Belgium 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

Belgium’s joint review is one of the most streamlined in the EU, and Brussels 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 Belgium is the better fit: if you want a single consolidated EU decision with published day targets, and European data is part of your plan. For a first implant where the US team wants to be present in person, a Latin American site in a nearby time zone is worth comparing.

Frequently asked questions

How long does FAMHP take to decide on a device investigation?

FAMHP validates within 10 days (T0), sends questions by T28 with up to a 20-day clock stop, and decides by T45, or T65 if experts are consulted.

Do ethics and FAMHP review separately in Belgium?

No. One dossier goes through CESP, and FAMHP and an ethics committee assess it together to issue one consolidated decision.

Are low-risk devices exempt from full assessment in Belgium?

No. FAMHP’s guideline says Belgium fully assesses investigations of every device class.

Can data from a Belgian 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 Belgium 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

• FAMHP, Guideline: Submission processes of clinical investigations according to MDR in Belgium, v12 (PDF)
• FAMHP, Medical devices and active implantable medical devices (clinical evaluation)
• 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)