We are very proud to announce that Ortivus has been certified under the Medical Device Regulation (MDR) and that MobiMed continues to be a CE marked medical device. The certification means that our medical technology solutions are now compliant with the new European legislation for medical technology products, that was installed to guarantee patient safety.
Ortivus has worked actively with the certification process for the past two years and on November 28, 2023 the company received its EC certificate with Ortivus MobiMed AB as the legal manufacturer. MobiMed has been CE marked under MDD for a long time.
"We are very happy to have received the certificate as many companies/products are still waiting to become certified. We are extra proud to be one of the first Swedish manufacturers of mobile patient monitoring systems to be certified and that we can continue to compete internationally." – says Magnus Mårtensson, Chief Product Officer and Deputy CEO.
The certification of Ortivus and the CE marking of MobiMed under the MDR has been made possible thanks to Ortivus’ competent employees. We have also benefited greatly from the fact that all functions, from development, quality and production to marketing, sales, and service, are under the same roof at our headquarters in Danderyd, Sweden.
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.
Ortivus is today certified according to ISO 13485, ISO 27001 and ISO 20000-1. The certified management systems together with the EC certificate of the MDR enable us to CE mark our medical technology solutions under the MDR.