UST-41 version 1

Provision of Promotional Samples of Medical Devices and in Vitro Diagnostic Medical Devices

This Guideline supersedes Guideline UST-41 as of 31 October 2023.

The Guideline is based upon legislative conditions stipulated by:

UST-41_version1_Provision of Promotional Samples of Medical Devices and in Vitro Diagnostic Medical Devices.pdf, file type pdf, (386.37 kB)

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter referred to as the “MDR”)
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (hereinafter referred to as the “IVDR”)
• Act No 40/1995 Coll., on Advertising Regulation and on Amendments to Act No 468/1991 Coll., on the Operation of Radio and Television Broadcasting, as amended (hereinafter referred to as “Act No 40/1995 Coll., on Advertising Regulation”)
• Act No 375/2022 Coll., on Medical Devices and in Vitro Diagnostic Medical Devices (hereinafter referred to as “Act No 375/2022 Coll.”)
• Act No 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended (hereinafter referred to as “Act No 48/1997 Coll., on Public Health Insurance”)
• Act No 95/2004 Coll., on Requirements for Acquisition and Recognition of Expert Competence and Specialised Competence to Practise the Profession of a Physician, Dentist and Pharmacist, as amended (hereinafter referred to as “Act No 95/2004 Coll.”)
• Act No 96/2004 Coll., on Requirements for Acquisition and Recognition of Competence for Pursuing Non-Medical Healthcare Professions and Activities Associated with the Provision of Health Care and on Amendment to Some Related Acts, as amended (hereinafter referred to as “Act No 96/2004 Coll., on Non-Medical Healthcare Professions”)
• Act No 372/2011 Coll., on Healthcare Services and the Conditions of Their Provision (Act on Healthcare Services), as amended (hereinafter referred to as “Act No 372/2011 Coll., on Healthcare Services”)
• Decree No 377/2022 Coll., implementing some provisions of the Act on Medical Devices and in Vitro Diagnostic Medical Devices (hereinafter referred to as “Decree No 377/2022 Coll.”)

This Guideline applies only to advertising for medical devices (hereinafter referred to as “MD(s)”) and in vitro diagnostic medical devices (hereinafter referred to as “IVD(s)”) and provides greater detail to the information presented in Guideline UST-39 Regulation of Advertising for Medical Devices and in Vitro Diagnostic Medical Devices concerning the provision of promotional samples of MDs and IVDs as referred to under Act No 40/1995 Coll., on Advertising Regulation, falling within the powers of the State Institute for Drug Control (hereinafter referred to as the “Institute”). The Guideline is of recommendatory nature.

Pursuant to the provision of Section 5k(1)(b), Section 5l(2), and Section 5m(2) of Act No 40/1995 Coll., on Advertising Regulation, the provision of samples of MDs and IVDs is deemed to be advertising.