Czech Republic Act No. 172/2022: In Vitro Diagnostic Medical Devices Regulation Implementation

1. Background and Purpose

Act No. 172/2022 Coll. (published in the Collection of Laws on 30 June 2022) implements Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the Czech Republic. It supplements the directly applicable EU IVDR with national provisions on competent authority roles, registration, language requirements, advertising, vigilance, clinical performance studies, and sanctions. Effective from 1 July 2022 (with transitional arrangements). Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

2. Competent Authorities

• State Institute for Drug Control (SÚKL) is designated as the national competent authority for IVDR matters, responsible for registration, vigilance, market surveillance, clinical performance study approvals, and coordination.
• Ministry of Health (MZ ČR) oversees overall implementation and policy.
• Czech Accreditation Institute accredits conformity assessment bodies.
• Notified bodies are designated by the Ministry of Industry and Trade.

Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

3. Registration and Notification Obligations

• Manufacturers, authorised representatives, importers must register with SÚKL before placing IVDs on the market (except certain Class A non-sterile devices).
• Registration includes UDI-DI (where applicable), economic operator details, device classification, intended purpose, and performance characteristics.
• Changes must be notified within 30 days.
• SÚKL maintains a public register of economic operators and IVDs.

Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

4. Language Requirements

• Instructions for use, labelling, and performance information must be provided in Czech (or Slovak, mutually intelligible).
• Electronic instructions permitted under IVDR conditions.
• Safety warnings and key information must be clearly understandable in Czech for lay users.

Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

5. Advertising Restrictions

• Public advertising of IVDs is prohibited for:
  • Class B, C, D devices
  • Devices intended for self-testing (except certain low-risk)
  • Devices with companion diagnostics function
• Permitted only for Class A non-sterile devices with strict content rules (no misleading claims, must include registration number).
• Professional advertising to healthcare professionals allowed with balanced risk/performance information.

Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

6. Vigilance and Post-Market Surveillance

• Serious incidents, field safety corrective actions, and trend reports must be submitted to SÚKL within IVDR timelines.
• SÚKL coordinates national vigilance, may request corrective actions, order recalls, or restrict supply.
• Manufacturers must maintain vigilance systems and cooperate with authorities.
• Records kept for at least 10 years (15 years for certain high-risk IVDs).

Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

7. Clinical Performance Studies

• National ethics committee and SÚKL approval required for interventional performance studies.
• Specific rules for vulnerable populations, informed consent, and compensation.
• Sponsor and investigator obligations aligned with IVDR and national law.

Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

8. Penalties and Enforcement

• Administrative fines up to CZK 20 million (€800,000 approx.) for serious violations (e.g., placing non-compliant IVDs, prohibited advertising, failure to report incidents).
• Lower fines (up to CZK 1 million) for minor breaches.
• SÚKL and Ministry of Health enforce compliance, including product withdrawal and supply bans.

Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

9. Transitional Provisions

• IVDs lawfully placed before full IVDR application (May 2022) can remain on market under transitional periods and legacy device rules.
• Existing registrations/notifications remain valid until expiry or major changes.
• Phased implementation of registration for legacy operators.

Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)

10. Practical Considerations for RA Managers

Prepare Czech/Slovak labelling and IFU early; register economic operators and IVDs with SÚKL promptly. Strictly limit public advertising to permitted Class A devices. Establish robust vigilance and trend reporting to SÚKL. Coordinate with SÚKL for performance study approvals. Monitor SÚKL guidance on registration portal, vigilance forms, and transitional arrangements. Source: Act No. 172/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0172-2022.pdf)