First-in-Human Medical Device Trials in Spain

Spain has one of Europe’s largest early device study counts and a strong home-grown device sector. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and how Spain lines up against Latin America for a United States (US) sponsor.

What the registry shows

Our query of ClinicalTrials.gov (CT.gov) found 116 early-stage, industry-sponsored device studies with at least one site in Spain, first posted between 1 January 2021 and 28 September 2026. That ranks Spain #6 worldwide on this measure. Of these, 48 used FIH, feasibility or pilot language in the title or summary, and 13 explicitly described a first-in-human or early feasibility study. 55 were run by sponsors headquartered outside Spain, 21 of them by US-headquartered companies, and 37 also listed sites in another country. Registrations went from 62 in 2021–2023 to 54 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 Spain

Spain applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) with Royal Decree 192/2023. According to the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS), each site needs three things before it can start:

1. AEMPS authorization. The application follows Annex XV of the MDR and is sent with proof that the fee was paid.
2. A single, binding favourable opinion from an accredited research ethics committee for medicines (Comité de Ética de la Investigación con medicamentos, CEIm).
3. Agreement from the site’s management (conformidad de la dirección del centro).

Timelines: AEMPS’s instructions (updated 29 December 2025) give 45 calendar days for most devices. For now, class I and non-invasive class IIa/IIb devices keep a one-month period under the older Royal Decree 1591/2009. AEMPS says the 45-day period will apply to every class once a new royal decree is published. The MDR allows 20 more days for expert consultation. The ethics review can run in parallel, but AEMPS needs the favourable CEIm opinion to authorize.

Language: AEMPS allows the protocol and investigator’s brochure in English if the CEIm agrees. Patient information, consent forms and labels must be in Spanish. Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

Where Spain is strong

• A deep domestic sector: 60 of 116 early studies were sponsored by Spanish-headquartered companies, and 13 were explicitly FIH or EFS.
• International use too: 55 studies came from sponsors headquartered elsewhere.
• Clinical range: Cardiovascular (27 studies), neurology (20) and oncology (13) led the mix, with neurology unusually strong.
• Spanish-language materials: consent forms and patient materials written for Spain are a useful starting point for Spanish-speaking Latin American sites, though each country’s ethics committee still reviews its own version.

Using data from Spain 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

Spain’s ethics and regulatory reviews can overlap, but the 45-day AEMPS clock still applies to most FIH devices, and Madrid 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 Spain is the better fit: if you want EU data under the MDR, your investigators are Spanish, or neurology is your area. A Spain-plus-Latin America plan also lets you reuse Spanish-language documents across both regions.

Frequently asked questions

How long does AEMPS take to authorize a device investigation?

AEMPS’s current instructions give 45 calendar days for most devices, and one month for class I and non-invasive class IIa/IIb devices until a new royal decree is published. The MDR adds 20 days if experts are consulted.

Can the CEIm ethics review run in parallel with AEMPS?

Yes, but AEMPS needs the CEIm’s favourable opinion in order to authorize. The CEIm issues a single, binding opinion.

Which documents must be in Spanish?

Patient information, consent forms and labels must be in Spanish. The protocol and investigator’s brochure may be in English if the CEIm agrees.

Can data from a Spanish 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 Spain 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

• AEMPS, Instructions for clinical investigations with medical devices in Spain (updated 29 Dec 2025)
• AEMPS, Clinical investigations with medical devices
• BOE, Royal Decree 192/2023
• 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)