Competent Authority
Contact Details
Clinical Investigation Authorisation / Registration / Notification
Submission Format
A Standard Application From for submission to the CA and the EC: "Wzór wniosku o wydanie pozwolenia na prowadzenie badania klinicznego"; available on the CA website (in Polish).
Language of Submission
Submission Fees
Fees for authorization:
1) Clinical investigation: 7000 PLN (approx. € 1700.- )
2) Amendments: 3000 PLN (approx. € 720.-)
Timelines Autorisation
Amendments/Substantial Amendments
Safety Reporting
"Form for medical incident notification"/ "Formularz zgłoszenia incydentu medycznego" (in en/pl).
Form available on the URPL website.
An annual safety report shall be submitted to the CA clinical investigations on MD (interventional and observational) and registries (MD CE-marked used within label are exempted from this obligation).
End of trial
Art 54 Medical Device Act 2010 (en)
Health Minister Order 15 Nov 2010 (related details on the final report)
In case of a multinational investigation, the relevant bodies of the Member States shall be notified of completing the clinical investigation.
Premature termination: The sponsor shall also notify the relevant bodies of the Member State and the European Commission if the investigation has been early terminated due to safety considerations.
Additional Information & Specifics
Summary of the description of the URPL Office related to medical devices:
President of the Office is a government administrative authority, competent for matters concerning marketing and use of medical devices – within the meaning and on the basis of the Act on Medical Devices of 20 May 2010 (O.J. No 107, item 679) and clinical trials within the scope determined by the Medical Devices Act of 20 May 2010.
The Office is a public administration body supporting the President of the Office in realization of the above matters.
The rules and the scope of responsibilities is determined by the Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Ethics Committee
Contact Details
Local RECs are established at academic institutions (e.g. medical universities), non-university medical research centres and health institutes or at the Regional Chambers of Physicians and Dentists.
List of ECs is provided on the website of the Regional Chamber of Physicians and Dentists in Warsaw (Okręgowa Izba Lekarska).
No central Ethics Committee.
Ethical Review - General
Single-Centre Studies - Ethical Review
The competent local Research Ethics Committee (“Bioethics Committee”) issues its reasonable opinion on the application of the clinical investigation.
Multi-Centre Studies - Ethical Review
The sponsor shall appoint a coordinator of clinical investigation from among all the clinical investigators involved in a multi-centre clinical investigation (Art 42 Medical Device Act 2010).
The sponsor or the designated coordinator shall submit the application to the EC (“Bioethics Committee”) where the coordinating investigator has his/her registered office.
This EC, acting as “lead” EC, shall inform all other ECs of the involved trial sites on the envisaged participation. They have 14 days to perform a site-specific assessment and submit reservations concerning the participation of the investigator or site in the clinical investigation.
The designated “lead” EC is authorized to issue a binding “single opinion” on the clinical investigation on behalf of the other involved ECs.
(Art 49 Medical Device Act 2010)
Submission of Application
The sponsor shall submit the request for approval of the clinical investigation to the local REC of the trial site. In case of a multi-centre investigation it shall be submitted to the EC where the coordinating clinical investigator has its registered office.
Submission Format
Form for submission of the clinical investigation to the CA and the EC (Wzór wniosku o wydanie pozwolenia na prowadzenie badania klinicznego) is available on the CA website (in Polish).
The application form is also provided in Annex 1 (Załącznik Nr.1) of Health Minister Order 15 Nov 2010.
The application documentation is specified in Art 44(3) (1-10) Medical Device Act 2010 (en)/ Dz.U. 2010 nr 107 poz. 679 (pl).
Language of Submission
Submission Fees
Depending on EC concerned: each regional Ethics Committee has its own payment criteria; eg Bioethics Commission Jagiellonian University:
Single center trial 1500 Euro
Multi-centre trial: 1500 Euro + 250 Euros for each subsequent examination center
Timelines Ethical Review
Amendments/Substantial Amendments
Depending on EC concerned: each regional Ethics Committee has its own payment criteria.
eg Bioethics Commission Jagiellonian University:
Single center trial 1500 Euro
Multi-centre trial: 1500 Euro + 250 Euros for each subsequent examination center
NB! A positive opinion of the competent EC is a prerequisite for application to the CA.
Safety Reporting
"Form for medical incident notification"/ "Formularz zgłoszenia incydentu medycznego" (in en/pl).
Available on URPL website in section: Wyroby Medyczne » Nadzor Rynku » Formularze.
End of trial
Premature termination of the clinical investigation: The sponsor shall also notify the relevant bodies of the Member State and the European Commission if the investigation has been early terminated due to safety considerations.
Study Specific Requirement
Sponsor
Definition of sponsor pursuant to Art 2 (28) Medical Device Act 2010:
“Any entity responsible for initiating and conducting a clinical investigation having the place of residence or the registered office in a Member State or acting solely through the agency of its legal representative having the place of residence or the registered office in a Member State”.
Definition of Authorised representative: see Art 2 (2) Medical Device Act 2010.
Investigator
The investigator may be a doctor or another person with professional qualifications necessary to perform a clinical investigation of a MD (pursuant to Art 40 Medical Device Act 2010)
In the case of clinical investigation of Active implantable MD, the clinical investigator may only be a doctor.
In terms of qualification, the clinical trials directive and guidlines (Volume 10), ICH E6 apply (qualified by training and experience).
Study participants - informed consent
Prior to the commencement of a clinical investigation with MD, informed consent must be obtained from study subjects according to the provisions specified in the national law.
Art 40 (4) and 56 Medical Device Act 2010 (en)
Art 37b (2) and Art. 37f Pharmaceutical Law 2001 (en)
Art 25 (1) Physician’s Profession Act 1996 (Dz.U. 1997 nr 28 poz.152)
Special provisions apply to vulnerable populations such as minors, incapacitated adults and subjects in emergency situations (Art 40 (4,10,11,13) Medical Device Act 2010).
Study participants - vulnerable population
Clinical investigations with MD on minors are possible under special provisions.
Clinical trials on minors include trials on: preterm newborns, full-term newborns (0-27 days), infants and small children (28 days-23 months), children (24 months-11 years) and teenagers (12-18 years).
A specific regulation issued by the Minister of Health covers in detail the provisions for the conduct of clinical trials on minors: Order of the Minister of Health 30 April 2004 (Dz.U. 2004 nr 104 poz. 1108)
Art 40 (10) Medical Device Act 2010 (en)
Order of the Minister of Health 30 April 2004 (Dz.U. 2004 nr 104 poz. 1108)
Art 40 (11-13) Medical Device Act 2010 (en)
Art 26 (2&3) of Act of 5 December 1996 on the professions of a physician and a dentist
Art 40 (11-13) Medical Device Act 2010 (en)
Art 26(1&2) Physician’s Profession Act 1996 (Dz.U. 1997 nr 28 poz. 152)
Not explicitly mentioned in Medical Device Act 2010.
Study participants - compensation & reimbursement
No incentives or financial inducements shall be given to study subjects, except compensation for any expenses incurred (pursuant to Art 40 (9) Medical Device Act 2010). Payment may be made to healthy volunteers of age taking part in bioavailability studies, or Phase I studies conducted in Poland.
Data protection
Notification of clinical investigations to GIODO is required for all clinical investigations of MD.
The right for the subject to personal data protection shall be safeguarded according to Art 40 (4.3) and 55 Medical Device Act 2010 and the Act on Patients’ Rights and the Spokesman for the Patients’ Rights 6 November 2008 (Dz.U. 2009 nr 52 poz. 417:
Before obtaining consent, the investigator shall inform the participant, that source documents will be available for monitoring purposes, internal and external audits. The sponsor must archive the documentation of a study for 5 years starting from the beginning of the year after the study was completed unless a contract between the sponsor and the investigator defines a different time period (Art. 37ra. par. 1).
Archiving & data management
National Legislations
General Information
ISAP (Internetowy System Aktów Prawnych, ang. The Internet System of Legal Acts), Online Database system of legal acts containing bibliographic and legal texts published in official publications (the Journal of Laws and the Polish Monitor) issued by the Prime Minister - https://isap.sejm.gov.pl/
Investigations on Medical Devices
Act of 7 April 2022 on medical devices (Dz.U. 2022 poz. 974 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20220000974/U/D20220974Lj.pdf)
- Act of 6 September 2001 on Pharmaceutical Law (Dz.U. 2001 nr 126 poz. 1381 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20011261381/U/D20011381Lj.pdf)
- Act of 5 December 1996 on proffesion's of physician and dentis, Article 25 (Dz.U. 1997 nr 28 poz. 152 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU19970280152/U/D19970152Lj.pdf )
- Order of the Minister of Health of 5 November 2010 for classification of Medical Devices (Dz. U. 2010 nr 215 poz. 1416 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20102151416/O/D20101416.pdf)
- Regulation of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Dz.U 2016 poz. 211 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20160000211/O/D20160211.pdf)
Combination studies (IMP/MD)
Radiation & Radiotherapy
Special requirement apply for the use of MD emitting radiation, as specified in:
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Regulation of the Minister of Health of 25 August 2005 on the conditions for the safe use of ionizing radiation exposure for all types of medical research
• Act of 29 November 2000 on Nuclear Law
Biobanking
CA operations/ Fees
Additional Information & Specifics
Definitions
MD/MD Investigation
Definition is in line with the provisions of the Regulation 2017/745:
"medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Definition is in line with the provisions of the Regulation 2017/745:
"clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;"