viQtor is CE certified!

We are incredibly proud that as of today August 24, viQtor is one of the first continuous monitoring solutions in Europe to be CE class IIa certified based on the Medical Device Regulation (MDR). The CE certification has been awarded for the complete solution: the device with the software (platform).

European Medical Device Regulations MDR

Since May 26, 2021, all manufacturers of medical devices must comply with the requirements of the European Medical Device Regulation MDR. This replaces the previous European Directives for medical devices (93/42/EEC). More and stricter quality guarantees, safety and effectiveness requirements for medical devices are defined in the MSS.

The aim of the new rules is to increase patient safety in the European Union. In addition, it provides more transparency to patients and healthcare providers with regard to information about medical devices (EUDAMED) on the European market. This way they can make a better choice for a resource. The MSS must also ensure that innovative medical devices remain available to patients.

The new regulations create important conditions for a well-functioning market for manufacturers of medical devices in the European Union. But importers, distributors and healthcare institutions cannot escape stricter supervision of the safety and traceability of medical devices.

Notified Body

A fully independent and impartial body designated by the government, a so-called 'notified body', assesses whether medium or high-risk medical devices meet legal requirements to be allowed on the European market.

Kiwa Dare is such an organization. It has checked whether smartQare has met the requirements. Based on an extensive audit, Kiwa Dare has certified us and we are entitled to apply the medical CE logo (followed by the 4-digit identification number of KIWA Dare) on our product viQtor. After receiving the certificate we can go to the market with viQtor

smartQare founders Reinier Vrolijk and Ronald Olie proud of CE certification

CE stands for 'Conformité Européenne': in accordance with European regulations. The CE1912 (visible on the product) therefore indicates that the product complies with the applicable rules within Europe.

smartQare was also ISO13485 certified in 2021.

Also read the blog "Quality management system at the heart of medical marking" by our quality manager Souraya Verhaegen

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