Notified Body (NB) by the European Union – QAI

QAI is a notified Body (NB)

QAI is a Notified Body (NB) designated by the European Union member states to certify products for the European market. A Notified Body (NB) is an independent, third-party organization to assess the conformity of certain products. It is most effective where harmonized standards are not followed fully, or standards are partially applied, or there are no applicable harmonized standard(s) available for the device. Also Notified Body can be very effective where Mutual Recognition Agreements (MRA) don’t exist.

A typical work of Notified Body (NB) is to establish specific test specification(s) and define appropriate test plan(s). Which include the task of assessing products covered by the RED about their technical conformity. The result is a type examination certificate that is recognized in all states of the European Union as well as in the EFTA states as the basis of a manufacturer’s Declaration of Conformity (DoC).

In these cases, the Notified Body conducts a Type Examination (Module B) or a Full Quality Assurance Assessment (Module H) to issue an EU-Type Examination Certificate, confirming compliance with the RED for wireless/radio, MDR for Medical, and EMC for non-radio and radio products.

This list includes:

• • Radio performance (efficient use of radio spectrum)
  • Electromagnetic compatibility (EMC)
  • Health and safety (including rf exposure to electromagnetic fields)
  • Interoperability and security, if applicable
  • Quality Assurance Assessment (Module H)

Notified Bodies are listed on the New Approach Notified and Designated Organizations (NANDO) database, maintained by the European Commission.

To obtain a CE mark, products with radio technologies must meet the requirements of the European Radio Equipment Directive 2014/53/EU (RED). This directive sets the legal framework for all products with radio technologies. Key defined requirements are health and safety, electromagnetic compatibility and efficient use of radio frequencies. Manufacturers and suppliers of these products to the EU market must demonstrate compliance with RED through a type examination certificate based on technical documentation (TD) or a self declaration (DoC) and affix the CE marking.

European Commission (CE) Links for more Information:

QAI’s clients benefit from our expert knowledge, turnaround time, and great customer service.  Being a recognized Notified Body (NB) allows QAI to assist our clients with a regulatory approval so your wireless products get to the market quickly and efficiently. 

Learn about our full scope of accreditation here: QAI Accreditations