Watch Ellie Reynolds, Associate Director of Regulatory Affairs at Proxima Clinical Research, as she breaks down the significance of Notified Bodies and equip yourself with the insight necessary to navigate the regulatory landscape in the EU!
Can't watch right now and rather read a quick summary? Here is a recap of what Grace shares in the video:
Hello. Ellie Reynolds here from the team at Proxima Clinical Research.
In this video, we're going to discuss notified bodies, what they are and what makes them important. Let's start by going over what exactly a Notified Body is
Notified Bodies are independent organizations designated by EU member states to assess the compliance of certain products, such as medical devices. They evaluate various aspects of the product, including design, manufacturing processes, quality systems and technical documentation to make sure they adhere to EU regulations and directives in what's known as a conformity assessment.
Once a Notified Body determines that a product meets the required standards, it issues a CE certificate that allows the manufacturer to create a declaration of conformity and affix the CE mark to their product, demonstrating compliance with EU regulations.
Notified Bodies operate as independent third party organizations and undergo accreditation by national accreditation bodies. They adhere to stringent regulations to ensure their competence, impartiality and reliability throughout the conformity assessment process.
Their role as independent evaluators adds an additional layer of scrutiny and assurance, instilling confidence in consumers and regulatory authorities that products on the market in the EU meet the necessary safety and quality standards.
The European Commission maintains an updated list of Notified Bodies which can be found in a database called New Approach. Notified and Designated Organisations or NANDO. It's important to note that the role of Notified Bodies may differ based on specific regulations and directives within different regions and countries.
Working with an experienced consulting firm or CRO is your best bet at making sure your product meets regulatory compliance ahead of an audit conducted by a Notified Body.
If you have any questions or need further guidance on navigating the compliance process, feel free to reach out to our team at proximacro.com.