This article was updated June 2, 2025. This article provides a general overview of the current medical device regulations in the Czech Republic.
Regulatory Authority:
The State Institute for Drug Control (Státní ústav pro kontrolu léčiv, or SÚKL) remains the primary government institution responsible for the regulation and clinical evaluation of both medical devices and pharmaceuticals in the Czech Republic.
Medical devices are classified into four classes based on their risk: Class I, Class IIa, Class IIb, and Class III. Class I devices are associated with the lowest risk, while Class III devices are associated with the highest risk.
Conformity with EU Medical Device Regulations:
All medical devices intended to be marketed in the Czech Republic must have a CE mark, indicating conformity with the European Union’s medical device regulations.
As of January 10, 2025, parts of Regulation (EU) 2024/1860 have come into effect, impacting medical device manufacturers.
Devices registered in the Czech Republic, or any other EU member state can be freely marketed within all European Union countries. Medical device registration in the Czech Republic and the EU is valid for five years; manufacturers intending to continue marketing their devices after this period must apply for renewal.
Foreign manufacturers are required to appoint an Authorized Representative within the European Union to carry out their device registrations.
Labeling Requirements:
All labels on medical devices must be in the Czech language and include:
- Country of origin
- Name of the product, manufacturer, and importer
- Instructions for use (not required for Class I and Class IIa devices unless necessary for user safety)
- Warning symbols, if applicable
Registry for Medical Devices RZPRO and ISZP:
The Register of Medical Devices (RZPRO), launched on May 1, 2015, continues to collect data on medical devices marketed in the Czech Republic. It provides information on all medical devices, Field Safety Notices, and registered entities approved since its inception.
In addition, the Medical Devices Information System (ISZP) has been introduced to streamline reporting for distributors and service providers. Entities must confirm the validity of their data annually or submit notifications of changes.
A Promising Medical Device Market:
The Czech Republic continues to be recognized as an innovator in the global medical device industry. With a population of approximately 10.6 million, the country offers opportunities for both domestic and international medical device manufacturers, driven by an increasing average lifespan and high demand for healthcare services.
Medical products in high demand include:
- High-end ultrasounds
- Video endoscopes
- Home care equipment
These developments underscore the Czech Republic’s commitment to maintaining a robust and transparent regulatory framework while supporting innovation in the medical device sector.
