MDR certificate obtained
in record time
MDR certificate obtained in OXYMAT - Slovakia s.r.o.
In May 2022, OXYMAT – Slovakia s.r.o obtained the Medical Device Regulation (MDR) certificate according to “Regulation (EU) 2017/475 on Medical Devices”.
The MDR certificate gives OXYMAT – Slovakia s.r.o. the right to market oxygen generators to the medical market within the European Union, and it has been adapted as a guiding certificate by many countries outside of the European Union.
Achieving this major milestone
The entire organisation in Slovakia has been involved in obtaining the new certificate and it has had some unexpected benefits.
Our Quality Manager, Alena Hlavatá point out: “The requirements of the MDR certificate are considerably more stringent then than its predecessor and as a benefit it has led to extended organisational focus on product risk assessment as well as data collection and data analysis.”
DNV has been the certifying body for the certificate in OXYMAT – Slovakia s.r.o. and they were very pleased to issue their first MDR certificate in Slovakia.
“The process leading to the MDR certificate took well over one year and was made possible only through extensive teamwork among employees and with the help of very qualified external consultants. I am very pleased with the result and the speed in achieving this major milestone for OXYMAT” says, COO, Michael Meyer “and then in the coming year, we will use this achievement as a steppingstone to start up the MDR process in our facility in Denmark.”
The MDR certificate for OXYMAT – Slovakia s.r.o. is valid until May 2027 and replaces the MDD certificate. The MDD certificate in OXYMAT A/S is valid until May 2024. Learn more about our Quality and certificates.
What is medical oxygen
Medical oxygen is high purity oxygen and is essential in the treatment of many intensive care procedures including, but not limited to surgery, pneumonia, COVID-19, neonatal and maternal health.