Conformity assessment to Technical Regulations

The process of confirming compliance with the requirements specified in the technical regulations. For medical devices, this refers to Technical Regulation No. 753 concerning medical devices, No. 754 concerning in vitro diagnostic medical devices, and No. 755 concerning active implantable medical devices.

Conformity assessment of medical devices to Technical Regulations involves verifying whether a medical device meets the requirements established by the respective Technical Regulation.

This process can be carried out in various ways, depending on the requirements of the specific Technical Regulation and the characteristics of the medical device. Typically, conformity assessment involves submitting an application to a conformity assessment body. This body reviews the manufacturer’s documentation, including the technical documentation of the medical device and the manufacturer’s quality management system.

Conformity assessment of medical devices to Technical Regulations is a crucial step in ensuring the safety and effectiveness of medical devices for patients and healthcare professionals. It ensures that the device meets quality and safety standards and helps avoid potential negative consequences of using unsuitable medical devices.