Basic legal and ethical standards
- Act of July 7, 2023 on the Professions of Doctor and Dentist (Journal of Laws of 2023, item 1516) READ MORE >>>
- Regulation of the European Parliament and of the Council (EU) No. 536/2014 of April 16, 2014 on clinical trials of medicinal products used in people and the repeal of Directive 2001/20/EC (Official Journal EU L 158 of 27/05/2014, p. 1, as amended p. 13) READ MORE>>>
- Act of March 9, 2023 on clinical trials of medicinal products used in humans (Journal of Laws item 605) READ MORE>>>
- Regulation of the European Parliament and of the EU Council no. 2017/745 of April 5, 2017 on medical devices, amendments to Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No. 1223/2009 and repeal Council Directives 90/385/EEC and 93/42/EEC, the so-called MDR – Medical Device Regulation READ MORE>>>
- MDCG (Medical Device Coordination Group) guidelines READ MORE>>>
- Act of April 7, 2022 on medical devices. (Journal of Laws of 2022, item 974) READ MORE>>>
- ISO 14155 Clinical testing of medical devices for humans – Good clinical practice, purchased at the Polish Committee for Standardization
- Clinical investigation of medical devices for human subjects – Good Clinical Practices
- Regulation 2017/746 of the European Parliament and of the EU Council of April 5, 2017 on in vitro diagnostic medical devices and repeal Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR) READ MORE>>>
- ICH E6 (R2) GCP Good Clinical Practice – Scientific guideline READ MORE>>>