Czech Republic Act No. 89/2021: Key Amendments to Pharmaceuticals Act Supporting MDR Implementation

1. Background and Legislative Intent

Act No. 89/2021 Coll. (published 26 March 2021, effective 1 May 2021) amends Act No. 378/2007 Coll. on Pharmaceuticals as part of the national transposition package for Regulation (EU) 2017/745 on medical devices (MDR). The amendments prepare the domestic legal framework for MDR application from May 2021, addressing gaps in previous legislation regarding vigilance, market surveillance, advertising, clinical investigations, and enforcement. Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

2. Updated Definitions and Scope

• Medical device: fully aligned with MDR Article 2 definition, including software and accessories.
• Economic operators: clarified roles and obligations for manufacturers, authorised representatives (must be EU/EEA-based), importers, distributors.
• Borderline products: provisions for case-by-case determination between pharmaceutical and device classification.

Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

3. Competent Authority Designation and Powers

• State Institute for Drug Control (SÚKL) formally designated as the national competent authority for MDR.
• Expanded powers: market surveillance, vigilance coordination, clinical investigation approvals, inspections, corrective actions, product bans/withdrawals.
• Obligation to cooperate with EU bodies and upload data to EUDAMED.

Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

4. Vigilance System Integration

• Mandatory reporting of serious incidents, field safety corrective actions (FSCA), and trend reports to SÚKL.
• Timelines and content requirements harmonised with MDR Articles 87–90.
• SÚKL coordinates national vigilance, issues Czech-language field safety notices, and may order urgent measures.

Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

5. Advertising and Promotion Restrictions

• Prohibition of public advertising for Class IIa, IIb, III, and implantable devices.
• Allowed only for certain low-risk devices with strict content rules (no therapeutic claims, must include SÚKL registration number).
• Professional advertising to healthcare professionals permitted with mandatory risk/benefit balance.

Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

6. Clinical Investigations Framework

• National authorisation process for MDR clinical investigations via SÚKL and ethics committees.
• Requirements for informed consent, insurance, compensation for trial participants.
• Sponsor obligations for safety reporting and end-of-study notifications.

Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

7. Registration and Operator Obligations

• Mandatory registration of economic operators and devices with SÚKL.
• Authorised representatives required for non-EU manufacturers.
• Importers and distributors must verify compliance and report non-conformities.

Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

8. Enforcement and Penalties

• Administrative fines significantly increased: up to CZK 20 million for serious breaches (e.g., placing unsafe devices, failure to report incidents).
• Lower fines for administrative violations.
• SÚKL empowered to impose immediate measures including supply suspension and recalls.

Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

9. Transitional Arrangements

• Legacy devices under Directive 93/42/EEC may continue under MDR transitional provisions.
• Existing national certifications/registrations remain valid during transition.
• Grace periods for new vigilance and registration requirements.

Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)

10. Practical Considerations for RA Managers

Assess portfolio for MDR classification and transitional eligibility. Strengthen vigilance processes for prompt SÚKL reporting (prepare Czech FSN). Limit public advertising strictly to permitted classes. Register operators/devices with SÚKL early. Prepare documentation and insurance for clinical investigations. Track SÚKL MDR guidance and EUDAMED readiness. Source: Act No. 89/2021 Sb. (https://mzd.gov.cz/wp-content/uploads/2021/03/Z%C3%A1kon-%C4%8D.-89_2021-Sb..pdf)