Welcome to the CMI Medical section - Center for Certification of Medical Devices!
CMI has available capacities to receive applications for conformity assessment.
On these web pages, you will find all the important information you need for the conformity assessment process of your medical device and for communicating with the Czech Metrology Institute. Please navigate through the tabs in the left column of the screen.
ABOUT CMI MEDICAL
The Czech Metrology Institute (CMI) is a contributory organization established by the Czech Ministry of Industry and Trade in 1993. Its purpose is to fulfil the functions of the national metrology institute in the fields of science, research, and the application of metrology knowledge to practical use. Through its activities, it ensures the uniformity and accuracy of measuring instruments and measurements across all fields of scientific, technical, and economic activities, particularly in metrology, medical devices, and electronic communications. CMI's services are provided by a wide team of highly qualified experts with extensive experience in all areas mentioned above.
The Center for Certification of Medical Devices, CMI Medical, was established in 2023 when CMI was officially designated as a notified body under Regulation 2017/745 MDR. This designation authorized it to perform conformity assessment activities for medical devices according to the MDR and to carry out post-certification surveillance, which is necessary to maintain the validity of medical device certifications under the MDR.
Notification of the authorization to carry out the activities of a notified body in the field of conformity assessment of medical devices according to the MDR together with the scope for this activity (list of MDR codes) can be found in the database of the European Commission Single Market Compliance Space HERE or in the official confirmation document issued by the Czech Office for Standards, Metrology and Testing HERE.
The vision of ČMI Medical is to be a trusted and professional partner that, through its expertise, ensures the delivery of safe and effective medical devices to the market, fully complying with all regulatory requirements.