Welcome to the CMI Medical section - Center for Certification of Medical Devices!
CMI still has available capacities to receive applications for conformity assessment
If you are interested in taking advantage of the transition period under EU Regulation 2023/607 (Amendment to the MDR), you are required to lodge a formal application for conformity assessment of medical devices with a notified body by 26 May 2024 at the latest.
The submission of the application is preceded by the process of submitting a non-binding inquiry, a review of the inquiry by the notified body and the preparation of a quotation. For this reason, applicants are strongly recommended to submit their inquiries as soon as possible.
If a non-binding inquiry is submitted after 10 May 2024, we are not be able to guarantee that the process will meet the deadline.
On December 22, 2023, the Czech Metrology Institute (CMI) was officially designated as a Notified Body in accordance with Regulation 2017/745
From this date, manufacturers can send non-binding inquiries and requests to CMI for the conformity assessment of their medical devices.
On these web pages, you will find all the important information you need for the conformity assessment process of your medical device and communication with the Czech Metrology Institute. Please follow the individual tabs in the left column of the screen.
If you have any questions, do not hesitate to contact our staff directly, who will be happy to help you with anything. Contact details can be found in the "Contact Us" tab.
We are looking forward to collaborating with you!
The CMI Medical Team