When Must a Notified Body Be Involved?

Introduction to the Role of Notified Bodies

Notified Bodies play a central role in the conformity assessment process of medical devices and medical software. These independent organizations are designated by the competent national authorities and are responsible for verifying compliance with applicable European regulations. Involvement of a Notified Body is particularly required for products classified into higher risk categories.

Risk Classification of Medical Devices

The risk classification is carried out according to Regulation (EU) 2017/745 on medical devices. Products are divided into four classes: Class I, IIa, IIb, and III. The classification is based on the risk the product poses to the patient or user. While Class I products generally do not require a Notified Body, products of classes IIa, IIb, and III must undergo a comprehensive assessment by a Notified Body.

Requirements for the Notified Body

The Notified Body conducts various tests to ensure the product's compliance with relevant requirements. These include:

• Technical Documentation: Review of the technical documentation that demonstrates the safety and performance of the product.
• Clinical Evaluation: Assessment of the clinical data supporting the product's efficacy and safety.
• Quality Management System: Review of the manufacturer's quality management system to ensure it meets the requirements.

Conclusion

Involving a Notified Body is a crucial step for the market approval of medical devices and medical software in Europe. Manufacturers should familiarize themselves early with the requirements and the process of designation to ensure their products successfully pass the necessary tests. Correct classification and timely involvement of a Notified Body are essential for compliance with legal requirements and ensuring product safety.