This article provides a general overview of the current medical device regulations in the Czech Republic.
The State Institute for Drug Control, or Státní ústav pro kontrolu léčiv (SUKL) in Czech, is the government institution responsible for the regulation and clinical evaluation of both medical devices and pharmaceuticals in the Czech Republic. Medical devices in the Czech Republic, just like in all other EU member states, are classified into four classes based on their risk: Class I, Class IIa, Class IIb, and Class III. Class I medical 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. CE marking is proof of conformity with the European Union’s medical device regulations. A device registered in the Czech Republic or in any of the other EU member states can be freely marketed within all European Union countries. Medical device registration in the Czech Republic and the EU is valid for 5 years. If manufacturers intend to continue to market their device in the European Union after this period, they must apply for a renewal.
Foreign manufacturers are required to appoint an Authorised Representative, who can be based anywhere in the European Union, to carry out their device registrations in EU. More information on medical device regulations in the European Union can be found in our guide to EU MDR and IVDR regulations.
All labels on medical devices must be in the Czech language. It is required to include the following information on the label:
- Country of origin
- Name of the product, manufacturer, and importer
- Instructions for use (not required for Class I and Class IIa devices, unless the information is necessary for ensuring the safety of users)
- Warning symbols, if applicable
Registry for Medical Devices (RZPRO)
RZPRO is a registry for medical devices in the Czech Republic that was launched on May 1, 2015. The system was created in order to collect data on medical devices marketed in the Czech Republic and is accessible by both competent authorities and the public.
The widely accessible, public part of the database was created for informational purposes only. It provides information on all medical devices, Field Safety Notices, and registered entities that have been approved since May 1, 2015.
The other part of the platform provides competent authorities with information on products, importers, distributors and Notified Bodies, incident reports, and data on conducted clinical trials.
A Promising Medical Device Market
In 2018, during the Hong Kong International Medical Fair Seminar, the Czech Republic was showcased as a top innovator in the global medical device industry.
“Although we are only a small European country, our health care is among the best in the world and the Czech Republic has a long history in medical device production, with world-class technology and smart ideas,” said Czech Deputy Minister of Health, Radek Policar.
With a population of only 10.625 million, the Czech Republic is one of the smaller countries in Europe. However, due to an increasing average lifespan and a high national demand for healthcare services, the country provides domestic and international medical device manufacturers with many opportunities. Medical products that are in the highest demand include high-end ultrasounds, video endoscopes, and home care equipment.