viQtor is CE certified
viQtor has, the first continuous monitoring solution based on IoT in Europe, received a CE certification class IIa. The CE certification has been awarded for the complete solution: the device with the software (platform).
European regulations on medical devices MDR
All manufacturers of medical devices must comply with the requirements of the European Medical Device Regulation (MDR) Directive since 26 May 2021. This replaces the earlier European Directives for medical devices (93/42/EEC). The MDR defines more and stricter quality guarantees, safety and effectiveness requirements for medical devices.
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 regarding information about medical devices (EUDAMED) on the European market. This way they can make a better choice for a tool. The MDR must also ensure that innovative medical devices remain available to the patient.
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 either.
A fully independent and impartial body designated by the government assesses whether medium- or high-risk medical devices meet the legal requirements for admission to the European market. Such an authority is also referred to as a 'notified body'.
Kiwa Dare is such an organisation. It has checked whether smartQare has met the requirements. Based on an extensive audit, Kiwa Dare has certified us and we are entitled to affix the medical CE logo (followed by the 4-digit KIWA Dare identification number) to our product. The certificate provides viQtor access to all MDR compliant markets
CE stands for 'Conformité Européenne': in accordance with European regulations. The CE marking on the product therefore indicates that the product complies with the applicable rules within Europe.
smartQare was already ISO13485 certified in 2021.
Also read the blog of our quality manager Souraya Verhaegen.