RAPS – the Regulatory Affairs Professionals Society – takes stock of the accreditation of new notified bodies for MDR and those in the process for accreditation. While many Notified Bodies for the Medical Devices Directive have decided not to apply for MDR 2017/745, others are waiting for their designation.

Among the last ones, also Ente Certificazione Macchine which, as reported by the RAPS itself, “received last September a joint assessment by the European Commission and the Italian national authorities as part of the MDR designation process”.

Actually, ECM is in the middle of the certification, our staff is working hard to complete the last activities necessary in order to get to the final stage of the designation procedure as soon as possible.

In the meantime, ECM has launched a range of training services to focus on the key issues of the future legislative system. The goal of ECM training services is to provide companies and professionals with a competent and authoritative training, for a better insight into the changes under way and a correct implementation of the new regulation.

For further information on our services in the medical devices sector, please contact ECM Sales Manager Antonio Balassone at antonio@entecerma.it | mob. +39 3932471040