How to Use NANDO to Find a Notified Body for Medical Devices
The New Approach Notified and Designated Organisations (NANDO) database, maintained by the European Commission, is an essential tool for manufacturers seeking to identify a Notified Body for Medical Devices or In Vitro Diagnostic Medical Devices under MDR (EU 2017/745) or IVDR (EU 2017/746). Follow this step-by-step guide to use NANDO effectively.
Step 1: Access the NANDO Database
Visit the European Commission's section for Notified Bodies.
Step 2: Locate the Search Options
Scroll down to the search section. You will find three main options:
- Search by Country - useful if you prefer a Notified Body in a specific EU country.
- Search by Legislation - ideal for finding Notified Bodies based on the regulations they cover.
- Free Search - suitable if you know the name of the Notified Body or have general search preferences.
Step 3: Select Search by Legislation
If you are unsure which Notified Body to choose, Search by Legislation is recommended. Upon selecting this option, you will see a list of EU directives and regulations.
- For medical devices, choose "Regulation (EU) 2017/745 on medical devices (MDR)."
- For in vitro diagnostic devices, select "Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)."
Step 4: Browse the List of Notified Bodies
On the next page, you will see a list of Notified Bodies working under the selected regulation. You can either:
- Scroll through the list manually.
- Use the Search options on the right-hand side to filter results.
Step 5: Select a Notified Body
Click on the name of a Notified Body that seems like a potential match for your needs. This will take you to a detailed page about that Notified Body.
Step 6: Review Notified Body Information
In this section, you will find:
- Notified Body Number
- Address and Contact Information
- Scope of Notifications - scroll down to see the regulations and annexes this Notified Body is designated for.
Step 7: Examine Notification Details
If the Notified Body covers MDR or IVDR:
- Review the procedures (Annexes) they are authorized to conduct.
- Check the descriptions and types of products they are notified for, categorized under MDA, MDN, or MDS codes.
Step 8: Evaluate the Scope of Notification
Compare the descriptions under the Scope of Notification to your product. If you find a match, this indicates that the Notified Body might be suitable for your product type. If not, consider looking at other Notified Bodies.
Step 9: Contact the Notified Body
If the Notified Body appears to meet your needs, reach out to them using the provided contact details to discuss potential cooperation.
Important Notes
- Notified Bodies have the right to decline cooperation requests due to unavailability or other reasons. If this happens, you will need to approach another Notified Body.
- Ensure that your technical documentation, quality management system, and other regulatory requirements are in order before initiating contact - this will be the first thing they will ask you about.
Conclusion
The NANDO database is a great tool for finding suitable Notified Bodies under MDR and IVDR. By following this guide, you can make the process of finding and working with a Notified Body much smoother and hassle-free.
