First-in-Human Medical Device Trials in Italy

Italy ranks fifth worldwide in our count of early-stage device studies and has a large domestic device industry. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and how Italy 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 Italy, first posted between 1 January 2021 and 28 September 2026. That ranks Italy #5 worldwide on this measure. Of these, 42 used FIH, feasibility or pilot language in the title or summary, and 10 explicitly described a first-in-human or early feasibility study. 46 were run by sponsors headquartered outside Italy, 19 of them by US-headquartered companies, and 33 also listed sites in another country. Registrations went from 64 in 2021–2023 to 52 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 Italy

Italy applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745). The regulator for device investigations is the Ministry of Health (Ministero della Salute).

• Regulator: before a pre-market investigation starts, the sponsor applies to the Ministry of Health under Article 70 of the MDR. For invasive class IIa, IIb and III devices, the MDR allows 45 days from validation, plus 20 days for expert consultation, with the clock stopped during questions.
• Ethics: one ethics opinion is issued nationally and covers all participating sites, according to the Careggi ethics committee’s instructions.
• Language and paperwork: the Careggi committee asks for the synopsis, labels, instructions for use and insurance documents in Italian. A sponsor based outside the EU must declare its EU legal representative (Art. 62(2) MDR).

The Ministry’s own device-investigation page was not reachable when we checked, so confirm current forms with the Ministry before you submit.

Where Italy is strong

• A domestic manufacturing base: 67 of 116 early studies were sponsored by Italian-headquartered companies.
• Distinct areas of strength: Cardiovascular (26 studies), dermatology, aesthetic and wound care (21) and orthopedic and spine (16) led the mix. Dermatology, aesthetics and wound care rank unusually high compared with other countries.
• International use: 46 studies came from sponsors headquartered outside Italy, and 33 had sites in other countries.
• One ethics opinion for a multi-site national study.

Using data from Italy 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

Italy uses one national ethics opinion but still requires Italian-language documents, and Rome 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 Italy is the better fit: for dermatology, aesthetic, wound-care or orthopedic devices with Italian investigators, or when EU data under the MDR is needed early. For a first implant that needs close US engineering support, compare a Latin American site.

Frequently asked questions

Who authorizes device investigations in Italy?

The Ministry of Health, under Article 70 of the MDR. An ethics opinion is also required.

How long does review take in Italy?

The MDR allows 45 days from validation for invasive class IIa, IIb and III devices, plus 20 days for expert consultation, with clock stops for questions. We do not quote an Italian median because we found no official figure.

Which documents need to be in Italian?

The Careggi ethics committee’s instructions list the synopsis, labels, instructions for use and insurance documents in Italian.

Can data from an Italian 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 Italy 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

• AOU Careggi, Pre-market device clinical investigation (Comitato Etico Regione Toscana, updated 23 Apr 2026)
• AIFA, Evaluation of device clinical investigations by ethics committees under Regulation (EU) 2017/745 (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)