MDR
Ortivus continuously works to improve its processes and products. In 2023, the company was certified under the new Medical Device Regulation (MDR).
On 28 November 2023, the company received its CE certificate, with Ortivus MobiMed AB as the legal manufacturer. MobiMed has been CE-marked under the previously applicable Medical Device Directive (MDD) for an extended period.
About the Medical Device Regulation (MDR)
The European medical technology industry has since 26 May 2021 been regulated by the Medical Device Regulation (MDR). The MDR aims both to achieve high safety and quality in medical devices that are manufactured, imported into, or sold within the EU. All products need CE marks under the MDR certificate to be marketed and sold within the EU.
The MDR creates a robust, transparent, sustainable, and internationally recognised framework that focuses on improved clinical safety. The MDR is thus a regulatory framework and replaces the former Medical Device Directive (MDD), which is a directive with fewer requirements, that does not have to be incorporated into national legislation.
We are proud to be one of the first Swedish manufacturers of mobile patient monitoring systems to be certified under the new regulation, and to continue competing on the international market.
Annette Henriksson
Quality Assurance & Regulatory Affairs Manager
Certificates
Quality Management System for the Design and Manufacture of Medical Devices
What does ISO certification mean?
By allowing an independent party to review and verify our operations, we ensure that our processes comply with the requirements set by each relevant ISO standard. This not only means that we meet legal and regulatory requirements, but also that we continuously improve our operations with a strong focus on quality and safety.