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What is NANDO and why medical device companies should know about it?

NANDO, which stands for New Approach Notified and Designated Organisations, is a central and official database maintained by the European Commission. It plays an important role in providing public access to information about organizations designated and notified under the New Approach Directives and Regulations in the European Union.


NANDO is a valuable tool within the EU's regulatory infrastructure, providing transparency, accessibility, and verification capabilities for stakeholders involved in conformity assessments, particularly those related to New Approach directives and regulations.

In other words, NANDO is a place where you can find a Notified Body that will certify your products.

What information you can find in NANDO

NANDO serves as a comprehensive and centralized repository for information on Notified Bodies in the EU. It includes details on organizations designated to perform conformity assessments and issue certifications for various products, including medical devices.

NANDO provides public access to information about designated Notified Bodies, including their scope of designation, identification numbers, and the member state that designated them. It allows manufacturers, regulatory authorities, and other stakeholders to verify the status and scope of designation of Notified Bodies.

Nando as a verification tool

For manufacturers seeking to work with a Notified Body, NANDO serves as a verification tool. Manufacturers can confirm whether a specific Notified Body is officially designated and whether its designation covers the type of products they manufacture.

NANDO features a user-friendly interface that allows users to search for Notified Bodies based on criteria such as the directive or regulation, identification number, and member state. This makes it easy for stakeholders to access the information they need.

NANDO enhances transparency and accountability in the regulatory system. By providing easy access to information about Notified Bodies, it ensures that stakeholders have the necessary information to make informed decisions and fosters trust in the conformity assessment process.

The information on NANDO is regularly updated to reflect changes in designations, additions of new Notified Bodies, and other relevant updates. This ensures that the database reflects the current status of Notified Bodies within the EU.

How to use NANDO


Here's a step-by-step guide on how to use NANDO:

  1. Visit the NANDO database through the official website of the European Commission. The URL for NANDO is typically available on the European Commission's official website related to New Approach directives and regulations.
  2. Once on the NANDO website, navigate to the search page or section. Look for options like "Search Notified Bodies" or "Find a Notified Body." This is where you can input criteria to look for specific Notified Bodies.
  3. Determine the criteria you want to use for your search. Select the specific regulation relevant to your product (MDR or IVDR). If you have a specific identification number for a Notified Body, you can use it for a direct search. Choose the member state in which the Notified Body is designated.
  4. Conduct the search
  5. Review search results. Examine the search results to find information about the Notified Bodies that match your criteria. The results will include details such as the name of the Notified Body, its identification number, the directive or regulation it is designated for, and the member state that designated it.
  6. Click on the name or identification number of a Notified Body in the search results to access more detailed information. This may include the scope of designation, contact details, and any specific conditions or limitations.
  7. Verify that the Notified Body maintains the official designation and that its scope covers the type of product or conformity assessment you are interested in. This is crucial for ensuring that the Notified Body is suitable for your certification needs.

We will help you obtain all the necessary certificates.

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What you need to have to succeed in certification and sell your products in the EU:

PRRC

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Clinical
evaluation
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Post-marketing
surveillance
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What you need to know to succeed in certification and sell your products in the EU:

CE-marking process under MDR

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CE-marking process under IVDR

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MDR checklist
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What is NANDO and why medical device companies should know about it?

NANDO, which stands for New Approach Notified and Designated Organisations, is a central and official database maintained by the European Commission. It plays an important role in providing public access to information about organizations designated and notified under the New Approach Directives and Regulations in the European Union.


NANDO is a valuable tool within the EU's regulatory infrastructure, providing transparency, accessibility, and verification capabilities for stakeholders involved in conformity assessments, particularly those related to New Approach directives and regulations.

In other words, NANDO is a place where you can find a Notified Body that will certify your products.

What information you can find in NANDO

NANDO serves as a comprehensive and centralized repository for information on Notified Bodies in the EU. It includes details on organizations designated to perform conformity assessments and issue certifications for various products, including medical devices.

NANDO provides public access to information about designated Notified Bodies, including their scope of designation, identification numbers, and the member state that designated them. It allows manufacturers, regulatory authorities, and other stakeholders to verify the status and scope of designation of Notified Bodies.

Nando as a verification tool

For manufacturers seeking to work with a Notified Body, NANDO serves as a verification tool. Manufacturers can confirm whether a specific Notified Body is officially designated and whether its designation covers the type of products they manufacture.

NANDO features a user-friendly interface that allows users to search for Notified Bodies based on criteria such as the directive or regulation, identification number, and member state. This makes it easy for stakeholders to access the information they need.

NANDO enhances transparency and accountability in the regulatory system. By providing easy access to information about Notified Bodies, it ensures that stakeholders have the necessary information to make informed decisions and fosters trust in the conformity assessment process.

The information on NANDO is regularly updated to reflect changes in designations, additions of new Notified Bodies, and other relevant updates. This ensures that the database reflects the current status of Notified Bodies within the EU.

How to use NANDO

Here's a step-by-step guide on how to use NANDO:

  1. Visit the NANDO database through the official website of the European Commission. The URL for NANDO is typically available on the European Commission's official website related to New Approach directives and regulations.
  2. Once on the NANDO website, navigate to the search page or section. Look for options like "Search Notified Bodies" or "Find a Notified Body." This is where you can input criteria to look for specific Notified Bodies.
  3. Determine the criteria you want to use for your search. Select the specific regulation relevant to your product (MDR or IVDR). If you have a specific identification number for a Notified Body, you can use it for a direct search. Choose the member state in which the Notified Body is designated.
  4. Conduct the search
  5. Review search results. Examine the search results to find information about the Notified Bodies that match your criteria. The results will include details such as the name of the Notified Body, its identification number, the directive or regulation it is designated for, and the member state that designated it.
  6. Click on the name or identification number of a Notified Body in the search results to access more detailed information. This may include the scope of designation, contact details, and any specific conditions or limitations.
  7. Verify that the Notified Body maintains the official designation and that its scope covers the type of product or conformity assessment you are interested in. This is crucial for ensuring that the Notified Body is suitable for your certification needs.

Further reading

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it

EUDAMED registration - a brief guide

Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)

GSPR – General Safety and Performance Requirements for medical devices in the European Union

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

IEC 62304 - the pivotal standard for software medical devices

Medical Device Regulation (MDR) - basics

ISO and IEC standards for medical device software

Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle

Notified Bodies and their role in certification of medical devices

What is NANDO and why medical device companies should know about it?

Labeling and UDI requirements for medical devices in the EU

Understanding the roles of Authorised Representatives and Importers under MDR/IVDR

MDR implementation - challenges and solutions

Post-market surveillance under MDR and IVDR - requirements and best practices

Notified Body audit - a manufacturer's guide

Risk management plan - guide for medical device companies

Should my medical device comply with GDPR?

EC-certificate for a medical device - Q&A

How long does it take to CE-mark a medical device?

What is a PRRC?

Essential requirements for importers and distributors under MDR and IVDR

Language requirements for IFUs and labels under the MDR and IVDR

Legal Manufacturer and Original Equipment Manufacturer in medical devices

How to structure a PRRC contract for effective compliance

How to Create a Declaration of Conformity According to MDR or IVDR

All articles >>

Get in touch

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Our EU office

MedDev Compliance Ltd
Souliou 1, Strovolos, 2018 Nicosia, Cyprus
Phone: +357 22253765
Email: info@mdrc-services.com
 

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Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

Read more >>


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Send us an email:
info@mdrc-services.com

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MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

PRRC under MDR or IVDR

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

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Medical software

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We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
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