Certificate for a medical device

The primary document that certifies the compliance of medical devices with regulatory requirements (technical regulations, directives). It applies to all medical devices except Class I devices and in vitro devices that are not listed in List A and List B of Technical Regulation 754 and are not self-testing devices.

A certificate for a medical device is a document that confirms the compliance of the medical device with the requirements established by legislation and quality standards. It is mandatory for obtaining before placing the medical device on the market/bringing it into Ukraine/European countries, etc.

The certificate for a medical device usually includes the product name, details about the manufacturer and authorized representative in the country, risk class, type of conformity assessment, and other relevant information.

The document is issued by an independent organization responsible for conformity assessment—a notified body—and confirms that the medical device meets the established quality and safety standards.

To successfully obtain the certificate, the manufacturer must have a quality management system compliant with ISO 13485, Technical Regulations, and other relevant legislation.

It is also important to note the necessity of having a technical file for the medical device, which includes relevant test results, a description of the manufacturing process, a list of applicable standards, clinical evaluation results, and risk assessment, among other things.

Given the significance of the certificate for the medical device’s market introduction, manufacturers and suppliers of medical devices should carefully familiarize themselves with legislative requirements and quality standards to obtain the necessary documents and ensure the safety and effectiveness of the devices for patients.