Czech Republic Act No. 171/2022: Medical Devices Regulation Implementation and National Provisions

1. Background and Purpose

Act No. 171/2022 Coll. (published in the Collection of Laws on 30 June 2022) implements Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the Czech Republic. It establishes national rules supplementing EU regulations, designates competent authorities, and regulates procedures not fully covered at EU level. Effective from 1 July 2022 (with some transitional provisions). Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

2. Competent Authorities and Notified Bodies

• Ministry of Health (MZ ČR) acts as the competent authority for MDR/IVDR implementation.
• State Institute for Drug Control (SÚKL) designated as national competent authority for vigilance, market surveillance, and coordination.
• Institute for State Control of Veterinary Biologicals and Medicines (ÚSKVBL) handles certain veterinary medical devices.
• Czech Metrology Institute (ČMI) involved in metrological control.
• Notified bodies designated by Ministry of Industry and Trade upon accreditation by Czech Accreditation Institute.

Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

3. Registration and Notification Obligations

• Manufacturers, authorised representatives, importers must register with SÚKL before placing devices on the market (except Class I self-certified devices in certain cases).
• Registration includes UDI-DI (when applicable), economic operator details, device classification, intended purpose.
• Changes must be notified within 30 days.
• SÚKL maintains public register of economic operators and devices.

Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

4. Language Requirements

• Instructions for use and labelling must be in Czech language (or Slovak, mutually intelligible).
• Electronic instructions allowed under MDR/IVDR conditions.
• Safety information and warnings must be clearly understandable in Czech.

Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

5. Advertising and Promotion Rules

• Advertising of medical devices to the public prohibited for:
  • Class IIa, IIb, III devices
  • Implantable devices
  • Devices with measuring function (certain cases)
• Allowed only for Class I and certain non-invasive devices, with strict content restrictions (no misleading claims, must include registration number).
• Professional advertising to healthcare professionals permitted with balanced risk/benefit information.

Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

6. Vigilance and Market Surveillance

• Serious incidents and field safety corrective actions must be reported to SÚKL within MDR/IVDR timelines.
• SÚKL coordinates national vigilance, may request additional data, order recalls, or restrict supply.
• Economic operators must cooperate with authorities and maintain records for at least 15 years (or longer for implants).

Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

7. Clinical Investigations and Performance Studies

• National ethics committee and SÚKL approval required for clinical investigations.
• Specific rules for vulnerable populations and compensation.
• Investigator and sponsor obligations aligned with EU requirements.

Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

8. Penalties and Enforcement

• Administrative offences punishable by fines up to CZK 20 million (€800,000 approx.) for serious breaches (e.g., placing non-compliant devices, false advertising).
• Minor infringements fined up to CZK 1 million.
• Ministry of Health and SÚKL enforce compliance, may impose measures including product withdrawal.

Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

9. Transitional Provisions

• Devices lawfully placed before full MDR application (May 2021) can remain on market until expiry of certificate or transitional periods.
• National derogations for certain legacy devices possible under EU conditions.
• Registration obligations phased in for existing operators.

Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)

10. Practical Considerations for RA Managers

Prepare Czech/Slovak labelling early; register all economic operators and devices with SÚKL promptly. Restrict public advertising strictly for higher classes. Strengthen vigilance systems for rapid reporting to SÚKL. Monitor SÚKL guidance on registration portal and vigilance forms. Coordinate with Czech notified bodies for conformity assessment continuity. Source: Act No. 171/2022 Sb. (https://mzd.gov.cz/wp-content/uploads/2023/02/sb0171-2022.pdf)