We are pleased to inform our customers, collaborators and the entire medical device industry that Ente Certificazione Macchine is moving in the final stage towards the designation as Notified Body according to the Regulation (EU) 2017/745.

Another step towards the goal has been achieved. In the last few days, we have received official communication from Accredia of the positive outcome of the assessment on our CAPA Plan, with the closure of the non-conformities raised during the audit. The task now passes to the Italian Ministry of Health for the further action required.

The pathway to MDR

The process to obtain the accreditation as Notified Body according to MDR 2017/745 is not easy at all. After having been audited by the JAT – the Joint Assessment Team composed of the European Commission, the Ministry of Health and Accredia – ECM worked hard to solve all the non-conformities found and to fully comply with the requirements imposed by the new regulation.

Even in the most difficult moment of the Covid-19 pandemic, our staff has worked non-stop in the certification activity of essential medical devices supporting the market, proceeding in parallel with the work of alignment with the provisions of EU Regulation 2017/745. This commitment has allowed us, despite the one-year delay of the MDR application, to continue our designation path according to the deadlines we had set.

Last October, we finalised a further documentary step, successfully assessed by Accredia, leading us to the final stage of the accreditation process. Now the Italian Ministry of Health will carry out further verifications and, as final step, will forward our case to the European Commission, which will conclude the process.

Considering the difficulties and the complex situation caused by the Covid-19 outbreak, we are very proud of the work that has been done so far. ECM is continuing its activities with the commitment and professionalism that has always distinguished us. We are confident that we will soon be designated as Notified Body for the MDR 2017/745 and will be able to provide the medical industry with this new certification service as well.

In the meantime, the work of our expert team for the certification of products under the Medical Device Directive (MDD) 93/42/EEC continues. With the application of the new MDR postponed by one year, companies have until 26 May 2021 to certify their devices according to the MDD, as well as to adapt their processes and products to the stringent standards imposed by the new regulation.

For more information about our services, you can contact our Sales Manager Antonio Balassone at antonio@entecerma.it | mob. +39 393 2471040. Or click on the button below to fill in the information request form.