With the approaching designation as Notified Body for the new European Medical Device Regulation 2017/745, manufacturers are welcome to contact us to ensure a place on our waiting lists.

A few days remain until the publication of ECM – Notified Body No. 1282 on the European Commission’s portal NANDO.

Our team is now preparing to start activities under MDR 2017/745.

As also underlined by the Italian Ministry of Health, which recently intervened at B.T. Expo – exhibition dedicated to biomedical technologies held in Modena – it is essential for manufacturers to hurry up to make their devices compliant to the MDR requirements and to contact a notified body to assess their conformity.

Furthermore, considering the current number of notified bodies compared to the number of certificates that will expire at the end of the transition period, in order to ensure that devices can continue to be placed on the market and avoid shortages of medical devices “it is essential that all manufacturers adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR” [MDCG 2022-11 Position Paper – Notice to manufacturers to ensure timely compliance with MDR requirements].

We therefore invite all medical device manufacturers to contact us as soon as possible in order to obtain more information and join our waiting list.

Contact us at: Eng. Diego Stevanella diego.s@entecerma.it | mobile (+39) 393 2471040