ECM’s Milestone Towards New Medical Device Regulation (MDR) 2017/745 Certification
Medical device manufacturers are now focusing their attention on their transition plans to the new MDR regulations which becomes mandatory on May 25, 2020. In addition, some manufacturers may be in a pickle in a few months if their Notified Body (NB) is not already into the application for MDR designation or announces their intentions not to submit their application.
ECM (Ente Certificazione Macchine) is well prepared. Our application passed the first stage of examination by the Italian authorities and was sent to the European Commission in January 2019.
And now, we are pleased to announce our momentum towards full accreditation. In September 2019, ECM will receive the joint assessment of the competent authorities – the European Commission and national authorities.
According to Andrea Secchi, President of ECM, “Our staff has been working hard for months towards this milestone. As our journey continues, ECM is looking forward to providing manufacturers with the opportunity to certify their medical devices according to the new Medical Device Regulation 2017/745 as soon as possible– helping them better prepare for CE marking strategy.”