Manufacturers seeking to market medical devices in the Czech Republic in 2026 must comply with EU Medical Device Regulation (EU MDR 2017/745), including EUDAMED registration, as well as oversight by the State Institute for Drug Control (SÚKL).
The Czech Republic continues to maintain a transparent regulatory system that aligns closely with EU standards while ensuring patient safety and market integrity.
Regulatory Authority in the Czech Republic
The primary regulatory body is SÚKL (Státní ústav pro kontrolu léčiv).
SÚKL is responsible for:
- Registration and approval of medical devices
- Market surveillance and inspections
- Field Safety Corrective Actions and vigilance monitoring
- Oversight of clinical investigations and conformity assessments
- Supervision of distributors, importers, and manufacturers operating in the country
SÚKL ensures all medical devices marketed in the Czech Republic meet EU MDR requirements and harmonized European standards.
Device Classification
The Czech Republic follows the EU MDR risk-based classification system:
- Class I: low-risk devices
- Class IIa: low-to-medium risk
- Class IIb: medium-to-high risk
- Class III: high-risk devices
Devices are also categorized by type, including general medical devices, in vitro diagnostics (IVDs), and active implantable devices.
Manufacturers classify their devices according to EU MDR Annex VIII rules. Class I devices can be self-certified by the manufacturer, while Class IIa, IIb, and III devices require Notified Body involvement for conformity assessment.
Combination products are classified according to their primary intended purpose.
CE Marking and Conformity Assessment
To place a device on the Czech market:
- All devices must carry a CE marking indicating MDR compliance
- Class I devices follow simplified conformity procedures and can be self-certified
- Class IIa, IIb, and III devices require Notified Body involvement for conformity assessment
- Documentation supporting compliance must be retained for at least five years (ten years for implantable devices)
- All labeling and instructions must be in Czech language, including country of origin, product details, warnings, and instructions for use
- Compliance with harmonized European or international standards (such as ISO 13485, ISO 14971) is mandatory
Class I device registration typically takes 4-6 weeks following submission to SÚKL.
EUDAMED Registration and Authorized Representatives
CRITICAL 2026 UPDATE: As of May 28, 2026, EUDAMED registration becomes mandatory for all medical devices in the EU.
EUDAMED Deadlines:
- May 28, 2026: All NEW devices must be registered in EUDAMED before being placed on the EU market
- November 28, 2026: Legacy devices (already on the market before May 28, 2026) must be registered
- Economic operators (manufacturers, authorized representatives) must register in the Actor module and obtain a Single Registration Number (SRN) before these deadlines
All manufacturers must:
- Register as an economic operator in EUDAMED
- Obtain a Single Registration Number (SRN)
- Submit UDI and device data
- Maintain vigilance and post market surveillance obligations
Non-EU manufacturers must appoint an EU Authorized Representative, who is responsible for legal compliance under MDR and serves as the point of contact with competent authorities.
Supply Interruption Notifications:
As of January 2025, Regulation (EU) 2024/1860 requires manufacturers to notify authorities of any supply interruptions or discontinuations that could result in serious harm to patients.
Czech Device Registries: RZPRO & ISZP
- ISZP (Medical Devices Information System) is the current system for distributors and service providers to notify their operations and submit device information. Data from the previous RZPRO system has been migrated to ISZP.
- RZPRO (Register of Medical Devices) continues to be used provisionally for certain transitional activities, including tracking Field Safety Notices and registered entities, pending full EUDAMED implementation.
Key Requirements:
- Annual confirmation of data validity is required for all entities registered in ISZP
- Distributors and service providers must submit change notifications when information is updated
- These systems support centralized device tracking and compliance reporting during the transition to full EUDAMED functionality
Czech Medical Device Market Overview
The Czech Republic is a promising market for both domestic and international manufacturers:
- Population: ~10.6 million
- High demand for advanced diagnostics and home care devices
- Popular products include high-end ultrasounds, video endoscopes, and home care equipment
- Strong regulatory transparency encourages innovation while ensuring patient safety
- Growing market with increasing healthcare investment
Manufacturers should align Czech market entry with EU-wide MDR compliance for efficient multi-country access.
Key Takeaways for 2026
To commercialize medical devices in the Czech Republic:
- Ensure full compliance with EU MDR 2017/745
- Obtain valid CE marking through appropriate conformity assessment route
- Complete EUDAMED registration by the mandatory deadlines (May 28, 2026 for new devices; November 28, 2026 for legacy devices)
- Appoint an EU Authorized Representative if you are a non-EU manufacturer
- Follow Czech registry obligations (ISZP for distributors/service providers)
- Ensure labeling and instructions are in Czech language
- Maintain structured post market surveillance and vigilance systems
- Notify authorities of supply interruptions per Regulation (EU) 2024/1860
- Implement ISO 13485 quality management system
Centralized regulatory planning and robust compliance systems are essential for success in the Czech and broader EU markets. With EUDAMED now mandatory as of May 2026, manufacturers must ensure their regulatory information management systems can handle both EU-wide EUDAMED requirements and country-specific obligations like ISZP.
