Notified Body

1. lut 28, 2025

What Does the 'Notified Body’ Mean?

A Notified Body is an organization designated by an EU country to assess the conformity of certain products before they are placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. They play a crucial role in ensuring that products meet essential health and safety requirements.

Notified Bodies are independent organizations that are 'notified’ by Member States to the European Commission and other Member States. They are responsible for carrying out conformity assessments, which may include inspection, testing, and certification of products. Manufacturers can choose any Notified Body in the EU that has been designated to carry out the conformity assessment procedure for their product.

Why Is the 'Notified Body’ Important in Clinical Research?

Notified Bodies play a crucial role in clinical research, particularly for medical devices and in vitro diagnostic devices. They ensure that these products meet the necessary safety and performance requirements before they can be marketed in the European Union, which is essential for protecting patient safety and maintaining public trust in clinical studies.

Understanding the role of Notified Bodies is important for researchers and manufacturers involved in clinical trials of medical devices. Their assessments and certifications are often required steps in the regulatory process, impacting study design, documentation, and timelines for bringing new medical technologies to market.

Good Practices and Procedures

1. Maintain strict independence and impartiality by implementing robust conflict of interest policies and regular audits of assessment processes.
2. Continuously update expertise through ongoing training programs and participation in relevant industry conferences and workshops.
3. Establish clear communication channels with manufacturers, including designated points of contact and structured feedback mechanisms throughout the assessment process.
4. Implement a rigorous quality management system that includes regular internal and external audits to ensure consistency and accuracy in conformity assessments.
5. Collaborate with other Notified Bodies and regulatory authorities to share best practices and harmonize assessment approaches across the EU.

Related Terms

• Training Compliance
• Primary Endpoint
• Clinical Database