UST-39 version 1

Regulation of Advertising for Medical Devices and in Vitro Diagnostic Medical Devices

This Guideline supersedes Guideline UST-39 as of 31 October 2023.

UST-39_version1_Regulation of Advertising for Medical Devices and in Vitro Diagnostic Medical Devices.pdf, file type pdf, (616.94 kB)

The Guideline is based upon legislative conditions stipulated by:

• 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 441/2003 Coll., on Trademarks and on Amendments to Act No. 6/2002 Coll. on Courts, Judges, Lay Judges and State Court Administration and on Amendments to Certain Other Acts (Act on Courts and Judges), as amended (hereinafter referred to as “Act No 441/2003 Coll., on Trademarks”)
• Act No 89/2012 Coll., the Civil Code, as amended (hereinafter referred to as “Act No 89/2012 Coll., the Civil Code”)
• Act No 634/1992 Coll., on Consumer Protection, as amended, (hereinafter referred to as “Act No 634/1995 Coll., on Consumer Protection”)
• 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)”) falling within the powers of the State Institute for Drug Control (hereinafter referred to as the “Institute”).

The Guideline explains terms and provides the positions of the Institute on advertising for MDs and IVDs. The Guideline is of recommendatory nature and to facilitate navigation within the particular areas, the text contains references to the legislation stipulating the relevant terms. As the area concerning MDs and IVDs is rather extensive, the text may not provide answers to your particular case; for this reason, please do not hesitate to contact the Medical Device Advertising Surveillance Unit of the Medical Device Regulation Section via e-mail at drzp@sukl.gov.cz, where your question will be answered. Information on advertising for MDs and IVDs is also available from /cs/dozor-nad-reklamou.