Medical Device Regulation (EU) 2017/745: ECM on the finish line

2 September 2022

ECM enters the final stage for designation as Notified Body for the new European Medical Device Regulation (MDR)

After a long and thorough evaluation process involving the European Commission, the Italian Ministry of Health and Accredia, Ente Certificazione Macchine is getting ready to be designated as Notified Body for Regulation (EU) 2017/745.

ECM has entered the final stage required to obtain the designation as Notified Body that will lead, in a short time, to the publication on the European Commission’s NANDO portal. Following the announcement of the designation, ECM will be able to perform the activity of conformity assessment of medical devices according to Regulation (EU) 2017/745.

Companies wishing to obtain information and join our waiting list may contact our Sales Manager Eng. Diego Stevanella at: | mob. (+39) 393 2471040

Following the recent important communications of the EU Medical Device Coordination Group (MDCG) addressed to manufacturers and notified bodies

which underline the importance for companies to promptly comply with the MDR requirements to ensure that devices can continue to be placed on the market and avoid shortages of medical devices, ECM also invites manufacturers to contact us as soon as possible to guarantee a place on our waiting list.