Czech Republic Act No. 90/2021: Amendments to the Pharmaceuticals Act for EU MDR Alignment

1. Purpose and Context

Act No. 90/2021 Coll. (published 30 March 2021, effective 1 May 2021) amends Act No. 378/2007 Coll. on Pharmaceuticals to prepare national legislation for the full application of Regulation (EU) 2017/745 on medical devices (MDR) from May 2021. It updates provisions on definitions, vigilance, market surveillance, advertising, clinical investigations, and administrative offences related to medical devices. Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

2. Key Definitions Updated

• Medical device: aligned with MDR Article 2(1) definition.
• Placing on the market / putting into service: consistent with MDR.
• Economic operators: manufacturer, authorised representative, importer, distributor.
• Borderline products: clarified when considered pharmaceutical vs. device.

Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

3. Competent Authority and Powers

• State Institute for Drug Control (SÚKL) designated as national competent authority for MDR implementation.
• Powers include: market surveillance, vigilance coordination, clinical investigation approvals, inspections, corrective measures, product withdrawal.
• Cooperation with EU authorities and EUDAMED.

Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

4. Vigilance and Incident Reporting

• Mandatory reporting of serious incidents and field safety corrective actions to SÚKL.
• Timelines and content aligned with MDR Articles 87–89.
• SÚKL may request additional data, coordinate FSCA, and issue field safety notices in Czech.
• Trend reporting and periodic summary reports required.

Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

5. Advertising Restrictions

• Public advertising prohibited for higher-risk devices (Class IIa, IIb, III, implantable).
• Permitted only for low-risk devices with mandatory inclusion of registration number and no misleading claims.
• Professional advertising to healthcare professionals allowed with balanced information.

Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

6. Clinical Investigations

• National approval process for clinical investigations of medical devices coordinated by SÚKL.
• Ethics committee review and informed consent requirements.
• Sponsor obligations for insurance, compensation, and reporting.

Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

7. Registration and Economic Operators

• Registration of economic operators and devices with SÚKL.
• Authorised representatives must be established in the EU/EEA.
• Importers/distributors obligations for verification and reporting.

Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

8. Administrative Offences and Penalties

• Fines up to CZK 20 million for serious violations (non-compliant placement, failure to report incidents, prohibited advertising).
• Lower fines for minor breaches.
• SÚKL enforces compliance and can impose corrective measures.

Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

9. Transitional Provisions

• Devices compliant under previous national law can continue under MDR transitional periods.
• Existing authorisations/registrations remain valid until expiry or re-assessment.
• Phased implementation for new vigilance and registration obligations.

Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)

10. Practical Guidance for RA Managers

Review legacy devices for MDR transitional compliance. Update vigilance procedures for SÚKL reporting (Czech FSN templates). Restrict public advertising to low-risk devices only. Register economic operators and devices promptly. Prepare for SÚKL inspections and clinical investigation approvals. Monitor SÚKL guidance on MDR implementation. Source: Act No. 90/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-90_2021-Sb..pdf)