What is a Notified body?
A Notified Body (NoBo) is an organisation authorised by a regulatory authority to certify the conformity of products and quality systems with specific standards and regulations. They are crucial in ensuring that products in regulated industries meet safety, quality, and performance requirements before placing them onto the European market.
When do you need a NoBo?
Depending on the directives, regulations and the subsequent comfomity assessment procedure, it may occur that the manufacturer has to put the technical file of the product at the disposal of a Notified Body to have their product and/or the Quality Management System certified.
The responsibility with regards to carry out the applicable conformity assessment procedure lies with the manufacturer. In general, for most product groups, the manufacturer should take all necessary measures to ensure that the manufacturing process is performed in a way that the products meet the requirements for affixing them with a CE Marking. For productgroups who require the certification by a Notified Body, the NoBo certifies that all necessary measures has been taken to meet the requirements for affixing the CE Marking. Furthermore, the NoBo certifies whether the manufacturer has properly compiled the Technical file, the EC/EU Declaration of Conformity and/or their Quality Management System.
As an illustration of a product category that necessitates involvement of a NoBo, consider medical devices, Class Im, Ir, and Is devices, along with all Class IIa, Class IIb, and Class III devices.
Streamlining Regulatory Compliance
Certification Experts offers a range of services to assist clients in engaging with Notified Bodies for regulatory compliance and certification. These services include regulatory guidance, documentation support, technical file reviews, QMS training, internal audits, guidance with QMS implementation and maintenance, market access advice (Route to Compliance), and keeping clients updated on regulatory changes. These services help clients ensure their products meet regulatory standards, save time and resources, and prevent compliance issues. If you need any of our services, please contact us.
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