First-in-Human Device Trials in the Netherlands

The Netherlands has a smaller early device study count than its neighbors, but a high share of feasibility-style work and heavy use by foreign sponsors. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is submitted there, what the registry shows, and how Latin America compares for a United States (US) sponsor.

What the registry shows

Our query of ClinicalTrials.gov (CT.gov) found 58 early-stage, industry-sponsored device studies with at least one site in the Netherlands, first posted between 1 January 2021 and 28 September 2026. That ranks the Netherlands #13 worldwide on this measure. Of these, 32 used FIH, feasibility or pilot language in the title or summary, and 6 explicitly described a first-in-human or early feasibility study. 44 were run by sponsors headquartered outside the Netherlands, 19 of them by US-headquartered companies, and 29 also listed sites in another country. Registrations went from 33 in 2021–2023 to 25 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 submission works in the Netherlands

The Netherlands applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745). The Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek, CCMO) runs the process through its Research Portal.

• Investigations for conformity assessment (MDR Articles 62 and 74(2), which covers most FIH studies): CCMO validates the research file first. It then passes the file to the review committee the sponsor chose, either an accredited medical research ethics committee (MREC) or the CCMO itself.
• Other investigations (Articles 74(1) and 82) go straight to the chosen MREC.
• Required files: CCMO’s standard research file for devices lists what to submit, including an EUDAMED (European Database on Medical Devices) form and the investigational device dossier.
• Timelines: investigations under Article 62 follow the MDR’s Article 70 clocks (validation, then 45 days for invasive class IIa, IIb and III devices, plus 20 days for experts). Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

Where the Netherlands is strong

• Feasibility-heavy: 32 of 58 early studies (55%) described themselves as FIH, feasibility or pilot studies, one of the highest shares in our data.
• Foreign sponsors: 44 studies came from sponsors headquartered outside the country, including 19 US-headquartered companies, and 29 had sites in other countries.
• One portal: CCMO’s Research Portal handles validation and routing.
• Therapeutic depth: Cardiovascular (13 studies), orthopedic and spine (8) and respiratory (7) led the mix.

Using data from the Netherlands 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

The Dutch process routes studies through one portal and one chosen committee, and Amsterdam 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 the Netherlands is the better fit: for feasibility studies that need EU data under the MDR, with sites used to foreign sponsors. For the very first implant, compare a Latin American option on time zone and on how easily the US team can attend.

Frequently asked questions

Who reviews device investigations in the Netherlands?

For investigations under MDR Articles 62 and 74(2), CCMO validates the file and passes it to the review committee the sponsor chose: an accredited MREC or the CCMO. Other investigations go directly to an MREC.

How do I submit a device study in the Netherlands?

Through CCMO’s Research Portal, using CCMO’s standard research file for medical devices, which includes an EUDAMED form.

How long does review take?

Investigations under Article 62 follow the MDR’s Article 70 clocks: validation, then 45 days for invasive class IIa, IIb and III devices, plus 20 days for experts. We do not quote a Dutch median.

Can data from a Dutch 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 the Netherlands 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

• CCMO, How to submit (medical device investigations)
• CCMO, Validation by CCMO of clinical investigations for conformity purposes
• CCMO, Standard research file medical devices
• 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)