Legal regulations of the Czech Republic

Laws

Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices, as amended – latest version effective from 23 August 2024

Decree of Ministry of Health No. 379/2022 Coll., on determining the amount of reimbursement of expenses for professional actions performed by the State Institute for Drug Control under the Act on Medical Devices and In Vitro Diagnostic Medical Devices

Decree of Ministry of Health No. 378/2022 Coll., on the design of the inspector’s card of the State Institute for Drug Control under the Act on Medical Devices and In Vitro Diagnostic Medical Devices

Decree of Ministry of Health No. 377/2022 Coll., on the implementation of certain provisions of the Act on medical devices and in vitro diagnostic medical devices

Act No. 90/2016 Coll., on conformity assessment of specified products when they are placed on the market, as amended – latest version effective from 15. 4. 2016

Act No. 40/1995 Coll., on the regulation of advertising and on the amendment and addition of Act No. 468/1991 Coll., on the operation of radio and television broadcasting, as amended (from 9 February 1995) – latest version effective from 22.12. 2022

Act No. 634/2015 Coll., on consumer protection, as amended – latest version effective from 6 January 2023

Act No. 48/1997 Coll., on public health insurance and on the amendment and addition of certain related laws (of March 7, 1997) – latest version effective from August 1, 2022

Act No. 526/1990 Coll., on prices, as amended – latest version effective from January 1, 2024

Price Regulation 1/2024/OLZP of the Ministry of Health of October 25, 2023, on price regulation of medical devices and in vitro diagnostic devices

Act No. 102/2001 Coll., on general product safety of products and on the amendment of certain laws (General Product Safety Act), as amended – latest version effective from April 6, 2023

Repealed laws and implementing regulations

Act No. 89/2021 Coll., on Medical Devices and on Amendments to Act No. 378/2007 Coll., on Medicines and on Amendments to Certain Related Acts (Medicines Act), as amended

Act No. 268/2014 Coll., on in vitro diagnostic medical devices, as amended

• Decree 170/2021 Coll., on determining the amount of reimbursement of expenses for professional actions performed by the State Institute for Drug Control under the Act on Medical Devices
• Decree 171/2021 Coll., on determining the amount of reimbursement of expenses for professional actions performed by the State Institute for Drug Control under the Act on in vitro diagnostic medical devices
• Decree 186/2021 Coll., on the implementation of certain provisions of the Medical Devices Act
• Decree 187/2021 Coll., which amends Decree No. 62/2015 Coll., on the implementation of certain provisions of the Medical Devices Act
• Decree No. 62/2015 Coll., on the implementation of certain provisions of the Act on in vitro diagnostic medical devices
• Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic medical devices
• Notice of the Ministry of Health No. 54/2022 Coll., on the operationalization of the central repository of electronic vouchers
• Decree No. 97/2022 Coll. to implement some provisions of the Act on Medical Devices relating to electronic vouchers
• Act No. 123/2000 Coll., on medical devices and on the amendment of some related laws, as amended
• Decree No. 61/2015 Coll., on determining the amount of reimbursement of expenses for professional actions performed by the State Institute for the Control of Medicines pursuant to the Act on Medical Devices
• Government Regulation No. 55/2015 Coll., on technical requirements for active implantable medical devices
• Government Regulation No. 54/2015 Coll., on technical requirements for medical devices
• Price Regulation 1/2023/OLZP of the Ministry of Health of November 30, 2022, on price regulation of medical devices and in vitro diagnostic medical devices

Implementing regulations to Act No. 123/2000 Coll., as amended:

• Decree No. 316/2000 Coll., which establishes the requirements of the final report on the clinical evaluation of a medical device, as amended
• Decree No. 501/2000 Coll., which establishes the forms and methods of reporting adverse events of medical devices, their registration, investigation and evaluation, documentation and its preservation and subsequent monitoring with the aim of preventing the occurrence of adverse events, especially their recurrence (Decree on Adverse Events incidents of medical devices), as amended
• Decree No. 11/2005 Coll., which establishes the types of medical devices with increased risk for users or third parties and on the monitoring of these devices after they are placed on the market
• Decree No. 356/2001 Coll., on the authorization of exceptions to the fulfillment of technical requirements for a medical device for its use in the provision of health care and on the scope of published data on their authorization
• Decree No. 100/2012 Coll., on the prescription of medical devices and the conditions for handling them, as amended
• Government Regulation No. 342/2000 Coll., establishing medical devices that may endanger human health
• Government Regulation No. 336/2004 Coll., which establishes technical requirements for medical devices and which amends Government Regulation No. 251/2003 Coll., which amends some government regulations issued to implement Act No. 22/1997 Coll. , on technical requirements for products and on the amendment and addition of certain laws, as amended
• Government Regulation No. 154/2004 Coll., which establishes technical requirements for active implantable medical devices and which amends Government Regulation No. 251/2003 Coll., which amends some government regulations issued to implement Act No. 22/1997 Coll., on technical requirements for products and on the amendment and addition of certain laws, as amended,
• Government Regulation No. 453/2004 Coll., establishing technical requirements for in vitro diagnostic medical devices, as amended