ECM for Medical Devices: one step closer to the new MDR

24 June 2020

We are proud to announce that Ente Certificazione Macchine – Medical Device Division has taken another step towards the accreditation for Regulation (EU) 2017/745.

Just few days ago, our staff has submitted the necessary documentation to close the non-conformities arising during the visit of the JAT. Last autumn, ECM received the audit of the Joint Assessment Team composed by European Commission, Italian Ministry of Health and Accredia, as required by the assessment procedure of notified bodies according to the MDR.

Thanks to the hard work performend in the last few months by our experts, who worked with commitment and dedication even during the lockdown to complete all the necessary activities as soon as possible, ECM is now closer to the final designation phase. We are hopeful to reach the goal as soon as possible, in order to offer an increasingly complete and professional conformity assessment service to the market.

With the delay to May 2021 of the application of Regulation 2017/745, ECM continues its certification activities as Notified Body for Directive 93/42/EEC (MDD). Contact our Sales Manager Antonio Balassone for more information at | cell. +39 393 2471040.