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The implementation of Regulation (EU) 2017/745 (MDR) is a difficult challenge for the entire medical device industry. All stakeholders involved, from notified bodies to manufacturers, are facing a progressive substantial transition to the new regulation, which is much more complex and stringent than the previous one.
However, despite their efforts, there are many concerns about the correct and sustainable implementation of the new regulatory regime by the entire system. The institutions themselves, aware of the current number of notified bodies compared to the number of certificates that will expire at the end of the transition period, invite all manufacturers to quickly comply with the MDR requirements and contact a notified body as soon as possible to start the certification process [source: MDCG 2022-11 Position Paper – Notice to manufacturers to ensure timely compliance with MDR requirements].
On the other hand, the medical industry is expressing concerns about the capacity of notified bodies to handle the large number of certification activities required by 2024. As of today, indeed, only a small part of the approximately 24,000 certifications of the former MDD/AIMDD directives have transitioned to MDR. Moreover, considering the high number of requests, an increasing number of notified bodies is no longer able to accept new certification applications. [For more data, see the EU Commission’s Notified bodies survey on certifications and applications].
There is a real risk of a shortage of medical devices on the market necessary for hospitals and end-patients.
Even ECM has addressed the concerns of manufacturers, who met at MEDICA in Dusseldorf last week to present products and services and exchange experiences and opinions. Our Sales Manager, who visited the event, reported great interest from companies wishing to start the EU certification process as soon as possible according to MDR. Many of them, however, find it difficult to get the right Notified Body.
Ente Certificazione Macchine – Notified Body No. 1282 for Regulation (EU) 2017/745, designated on Nando on 14 October 2022, is accepting new applications from manufacturers wishing to certify their medical devices under the MDR.
We therefore invite companies to contact us as soon as possible for more information, to know the timelines of the certification process and to obtain a tailor-made quotation. Contact us at:
Eng. Diego Stevanella – Sales Manager ECM
email@example.com | mob. (+39) 393 2471040