News

Notification of bodies for new MD regulations

logo team NB

The european association of notified bodies for medical devices Team-NB published the list of member bodies that intend to submit an application to be designated against the new regulations.

With no surprise, all 23 members of the association intends to ask for notification against MDR 2017/745. However, only 11 actually intends to also apply for notification against IVDMDR 2017/746, which is 50% less than for the current 98/79/CE directive.

This confirms the priority of notified bodies towards medical devices, which represent by far the largest part of their activities and income. This also suggest that some bodies among the Team-NB are facing limits in terms of ressources, that prevent them from applying for both notifications at the same time.

It is more difficult to know the intentions of notified bodies that are not Team-NB members, but we can reasonably expect that they will face more issues to fulfil the requirements of new regulations, as they were not able to sign the “Code of Conduct