Or use the contact form below
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.
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.
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.
Here's a step-by-step guide on how to use NANDO:
Learn more >>
PRRC
Learn more >>
Clinical
evaluation
Learn more >>
Post-marketing
surveillance
Learn more >>
CE-marking process under MDR
Learn more >>
CE-marking process under IVDR
Learn more >>
MDR checklist
Learn more >>
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.
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.
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.
Here's a step-by-step guide on how to use NANDO:
EC-certificate for a medical device – Q&A
How to structure a PRRC contract for effective compliance
Technical documentation for Medical Device Software in the EU
CE-Certificate vs. EC-Certificate
Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle
Notified Bodies and their role in certification of medical devices
How to Create a Declaration of Conformity According to MDR or IVDR
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 >>
We're ready to help you. Contact us whether you have a question about our solutions or need help with regulatory issues
©2024 MDRC - Medical Devices Regulatory Compliance
Medical Device Regulation (MDR) - basics
CE-marking process for medical devices
CE-marking process for in vitro diagnostic medical devices
MDR technical documentation checklist
IVDR technical documentation checklist
Technical documentation checklist for medical device software (MDSW)
MDR-compliant quality system documentation checklist
MDR-compliant quality system documentation checklist for medical device software
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 >>
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.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.
Or use the contact form below
Solutions
EU Authorised Representative (EC REP)
EU PRRC
Technical documentation
Risk management
Clinical evaluation
Notified Bodies
Quality management system
Post-market surveillance
Resources
Medical Device Regulation (MDR) - basics
CE-marking process for medical devices
CE-marking process for in vitro diagnostic medical devices
MDR technical documentation checklist
IVDR technical documentation checklist
Technical documentation checklist for medical device software (MDSW)
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 >>
Devices
General medical devices and equipment
In vitro diagnostics (IVD)
Medical software
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.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.