Many manufacturers still feel ‘stuck’ with their current Notified Body, yet the current regulatory landscape offers far more freedom than one might imagine.

The European Commission (Q&A, Revision 2, July 2024) has indeed confirmed a crucial point: if a medical device manufacturer terminates the relationship with a Notified Body and simultaneously transfers the application to another body (also designated under the MDR), the conditions for accessing the transitional period remain valid.

What does this mean in practical terms? It means you can benefit from greater operational capacity or a more agile service by choosing a different partner than your initial one, without losing the advantages of the transition.

THE SUPPORT OF ECM

We are pleased to announce that Ente Certificazione Macchine has joined the Normec Group.

Thanks to this operation, we are growing rapidly and expanding our technical staff. This allows us to offer even greater responsiveness and flexibility in supporting manufacturers through the challenges of MDR certification.