On 22nd December 2023 Czech Metrology Institute was designated as a notified body for conformity assessment of medical devices in accordance with the Medical Devices Regulation (MDR)
Czech Metrology Institute successfully completed a long and demanding journey through an approval process which began on 17.12.2020 with an application.
Czech Metrology Institute can now assess the conformity of medical devices for the following risk classes:
- Is – medical devices placed on the market in sterile condition
- Im – medical devices with measuring function
- Ir – reusable surgical instruments
- IIa
- IIb
and with a range of 20 basic MDR codes and 18 horizontal MDR codes.
Certificate of authorization to carry out conformity assessment activities for medical devices under the MDR and the scope of these activities (list of MDR codes) can also be found in the European Commission's Single Market Compliance Space database ZDE.
Manufacturers of medical devices can now send non-binding inquiries and requests for conformity assessment to CMI
Do you want to know more information or are you ready to submit a non-binding inquiry or request for a conformity assessment of your medical device?
- Visit the CMI Medical section to find out all the important information - ZDE
- Or you can contact CMI Medical's responsible employees directly at:
- Ing. Jan Kavalírek, Head of Contracting Department at CMI Medical – jkavalirek(a)cmi.cz, +420 728 472 322
- General email address of CMI Medical - Centre for Certification of medical devices – medical(a)cmi.cz