Do you Need a Notified Body?
- How to choose your NB
- In what time frame will they be able to process your file?
- How much will it cost?
- How to prepare for their Technical Documentation evaluation?
- How to prepare for their audits?
- How to communicate with them?
- How to manage the non-compliances detected ?
You will need the intervention of one of the Notified Bodies designated in most cases to obtain the CE marking certificate that will allow you to market your medical device.
But their capacity is limited to take in charge new devices because in 2014 there were 84 Notified Bodies (NBs) designated under the old directives, while there are only 24 to date for the new regulations.
You do not need a Notified Body if your Medical Device is Class I, not sterile, does not take measurement, or is a reusable surgical instrument.