Choosing the right Notified Body for your medical device can be confusing and time-consuming. As a trusted medical device regulatory consultancy, Maven makes it easier by helping you select the best Notified Body for MDR or IVDR. With our expert medical device regulatory consulting, we guide you every step of the way for a faster and smoother approval process.
What is a Notified Body?
A Notified Body (NB) is an organization designated by the European Commission and individual EU Member States to assess whether medical devices and in vitro diagnostic devices meet the safety and performance requirements of the EU MDR (2017/745) or IVDR (2017/746).
These bodies are independent and impartial, and they play a critical role in the CE marking process. For medium- and high-risk devices, manufacturers must work with a Notified Body to:
- Review the technical documentation
- Audit the Quality Management System (QMS)
- Perform conformity assessments
- Issue a CE Certificate if the device complies with all applicable regulatory requirements
Only after receiving CE certification from a designated Notified Body, a medical or IVD device can be legally marketed in the European Union.
How Are Notified Bodies Designated?
Notified Bodies are designated by the European Commission in coordination with the relevant national competent authorities of EU Member States. The designation confirms that the Notified Body is competent to carry out conformity assessments under MDR or IVDR for specific device types.
Each designated Notified Body is assigned a unique identification number, and their scope of designation (e.g., types of devices they are allowed to assess) is published and regularly updated by the European Commission.
