First-in-Human Medical Device Trials in Poland

Poland is one of the few European countries where early device study registrations grew between 2021–2023 and 2024–2026, and almost all of that work comes from foreign sponsors. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized 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 59 early-stage, industry-sponsored device studies with at least one site in Poland, first posted between 1 January 2021 and 28 September 2026. That ranks Poland #12 worldwide on this measure. Of these, 27 used FIH, feasibility or pilot language in the title or summary, and 10 explicitly described a first-in-human or early feasibility study. 49 were run by sponsors headquartered outside Poland, 18 of them by US-headquartered companies, and 27 also listed sites in another country. Registrations went from 28 in 2021–2023 to 31 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 Poland

Poland applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) through the Act of 7 April 2022 on medical devices. Applications go to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, URPL).

• Ethics first: the application must include a positive opinion from a bioethics committee, so the ethics step comes before the regulator’s review.
• Timelines: URPL follows Article 70 of the MDR. Validation comes first. For invasive class IIa, IIb and III devices there are 45 days from validation, plus 20 days for expert consultation, with the clock stopped during questions.
• Language: the application form may be in Polish or English. Patient information and consent forms must be in Polish.
• Other items: proof of insurance and a fee set by the Minister of Health are required. Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

Where Poland is strong

• Built for foreign sponsors: 49 of 59 early studies (83%) came from sponsors headquartered outside Poland, the highest share among the countries we profiled.
• Growth: registrations went from 28 to 31 across the two periods, even though the second period is shorter.
• Cardiovascular focus: Cardiovascular (30 studies), oncology (6) and orthopedic and spine (5) led the mix. Cardiovascular made up about half of all early studies.
• FIH work: 10 studies were explicitly FIH or EFS.

Using data from Poland 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

Poland requires the bioethics opinion before it reviews the application, and Warsaw 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 Poland is the better fit: for cardiovascular programs that need EU data under the MDR and sites used to foreign sponsors. For a very first implant where the US engineering team wants to attend, compare a Latin American option on time zone and travel.

Frequently asked questions

How long does URPL take to authorize a device investigation?

URPL follows the MDR’s Article 70 timelines: validation, then 45 days for invasive class IIa, IIb and III devices, plus 20 days for experts, with clock stops for questions. The bioethics opinion must be in hand first.

Is a bioethics committee opinion needed before applying to URPL?

Yes. URPL requires a positive bioethics committee opinion to accompany the application.

Which documents must be in Polish?

Patient information and consent forms must be in Polish. The application form itself may be in Polish or English.

Can data from a Polish 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 Poland 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

• URPL, Clinical investigations of medical devices (gov.pl)
• URPL, Application for permission to conduct a clinical investigation (gov.pl)
• 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)