Medical Device Technical File and Its Structure

The regulation created by the European Union Commission, which is obliged to comply with the medical device manufacturers; Medical Device CE Certificate. Determining all safety and performance parameters (chemical, physical, biological, biomechanical, sterility, biological load detection, rapid aging and compliance with other product-specific tests) that the product must provide in accordance with the 2017/745 MDR Medical Device Regulations and strategies for the application of these parameters, and As a result, compliance with these features needs to be proven. Medical Device Manufacturer; Compliance with the 2017/745 MDR Medical Device Regulation shows the Medical Device CE Certificate.

Getting CE certificate varies according to the risk group of the medical device. If the product is in the low risk group, it can be sold in the market with the "Declaration of Conformity" prepared under the responsibility of the medical device manufacturer.

However, if the medical devices are in the medium and high risk group, they must be inspected and approved by a notified body.

22 descriptive rules are used to help classify a medical device as Class 1, Class 1 Sterile and measuring, Class 2A, Class 2B and Class 3 according to risks.

The Process of Obtaining CE Certificate

• Determination of Product Class
• Determination of Conformity Assessment Target According to Risk Group
• Establishment of Quality Management System (ISO 13485)
• Creation of Technical Documentation
• Inspection Process by Notified Body
• Declaration of Conformity (CE) Receipt