Why do you need a Notified Body?
The services of a Notified Body must be contracted to perform a conformity assessment prior to market entry. The Notified Body will perform the conformity assessment based on an inspection of the company’s quality management system and assessment of the Technical Documentation for the device, based on type examination, or based on product conformity verification.
Helpful tips when selecting a Notified Body:
- The selected Notified Body should be appropriately designated and competent to assess and certify the specific medical device in accordance with the applicable CE conformity assessment requirements.
- Begin the selection process early, as the entire process from selection of a NB through CE Certification can take more than a year.
How we can help?
A. Stein – Regulatory Affairs Consulting has collaborated with numerous Notified Bodies and is well‑versed in their areas of expertise and the device types they are designated to certify, enabling us to effectively support you in selecting the Notified Body best suited to your medical device.
