UST-40 version 1

Recommending Guideline on the Term “Expert”

This Guideline supersedes Guideline UST-40 as of 01 November 2023.

UST-40_version1_Recommending Guideline on the Term “Expert”.pdf, file type pdf, (1.15 MB)

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”)
• Decree No 55/2011 Coll., on the operation of healthcare professionals and other expert staff (hereinafter referred to as “Decree No 55/2011 Coll.”)
• Decree No 77/2018 Coll., on the determination of particulars and specimen of some documentary evidence of education for accredited qualification courses, certified courses, and specialised education (hereinafter referred to as “Decree No 77/2018 Coll.”)

• 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 Paramedical 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”)

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 explains the term “expert” as referred to under the provision of Section 2a of 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”).