The European Medical Device Regulation 2017/745 (MDR) came into force on 26th May 2021, replacing the Medical Device Directive (MDD).
Quha Zono and Zono 2 were classified as Class I medical devices according to the MDD. Quha has taken all the necessary steps to ensure compliance with the more rigorous requirements of the new regulation. The Quha Zono and Quha Zono 2 mice continue to be classified as Class I medical devices under the MDR. The devices have been officially registered to the local regulatory authority for medical devices Finnish Medicines Agency.
All Quha Zono and Quha Zono 2 products delivered by Quha since today are official MDR medical devices.
Medical device distributors also have new responsibilities under the MDR. The MDR distributor obligations are listed on the European Commission’s Factsheet for Authorised Representatives, Importers and Distributors of medical devices and in vitro diagnostic medical devices.
View and download the Declarations of Conformity for Quha Zono and Quha Zono 2 via the links below:
MDR compliant user manuals are available here.
Contact Quha for more information.