Czech Republic Act No. 50/2022: Pharmaceuticals Act Amendment for Medical Devices and IVDs

1. Background and Purpose

Act No. 50/2022 Coll. (published in the Collection of Laws on 25 February 2022) amends Act No. 378/2007 Coll. on Pharmaceuticals to integrate provisions necessitated by the application of EU Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR) in the Czech Republic. It updates definitions, assigns responsibilities, and establishes national rules for devices that fall under pharmaceutical oversight or borderlines. Effective from the date of publication with phased implementation aligned to MDR/IVDR dates. Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

2. Key Definitions and Scope

Amends definitions to include:

• Medical device and in vitro diagnostic medical device as per EU MDR/IVDR.
• Borderline products between pharmaceuticals and devices.
• Clarifies scope for combination products (drug-device combinations) and ancillary medicinal substances in devices.

Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

3. Competent Authority Powers

• State Institute for Drug Control (SÚKL) is explicitly designated competent authority for medical devices and IVDs under MDR/IVDR.
• Expanded powers for market surveillance, vigilance coordination, clinical investigation approvals, and enforcement.
• Ministry of Health retains overarching policy responsibility.

Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

4. Registration and Notification

• Requires registration of economic operators and devices with SÚKL in line with MDR/IVDR obligations.
• Notification of serious incidents, field safety corrective actions, and trend reporting to SÚKL.
• Integration of device vigilance into the existing pharmaceutical adverse event reporting framework where relevant.

Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

5. Advertising and Promotion Controls

• Reinforces restrictions on advertising medical devices and IVDs to the public, particularly for higher-risk classes.
• Prohibits misleading claims regarding performance, safety, or therapeutic effects.
• Allows professional promotion to healthcare providers with mandatory balanced information.

Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

6. Vigilance and Post-Market Requirements

• Mandates manufacturers to establish vigilance systems and report to SÚKL.
• SÚKL may request additional post-market surveillance data or corrective actions.
• Coordination with EU vigilance database (EUDAMED) obligations.

Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

7. Clinical Investigations and Performance Studies

• National approval process for clinical investigations of medical devices and performance studies of IVDs coordinated by SÚKL.
• Ethics committee involvement and informed consent requirements aligned with EU standards.

Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

8. Sanctions and Enforcement

• Administrative offences related to non-compliance with MDR/IVDR provisions punishable by fines up to CZK 20 million.
• Graduated penalties for violations such as failure to register, prohibited advertising, or inadequate vigilance.

Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

9. Transitional Provisions

• Legacy devices under previous national law can continue under transitional periods per MDR/IVDR.
• Existing pharmaceutical registrations for borderline products remain valid until re-assessment.

Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)

10. Practical Considerations for RA Managers

Review product portfolios for borderline classifications under amended definitions. Update vigilance and advertising procedures to comply with SÚKL reporting and restrictions. Ensure timely registration of economic operators and devices. Prepare Czech-language labelling and documentation. Monitor SÚKL guidance on implementation and transitional arrangements. Source: Act No. 50/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2022/06/sb0050-2022.pdf)