Getinge announces first manufacturing site and products to be EU MDR certified
The new European law, EU medical device regulation (EU MDR), will be fully effective in May 2020 with a transition period until May 2024. Getinge drives a focused program to ensure selected manufacturing sites and products reaches compliance with it. In February 2020, the Solna factory in Sweden along with the intensive care unit ventilators Servo-u and Servo-n was first out of the bunch to receive the certificate.
An important step for Getinge to make the journey for reaching compliance with the new European law streamlined and predictable, has been to transfer selected manufacturing sites to one single Notified Body.
“During the fourth quarter of 2019 all selected sites were transferred to TÜV SÜD, specialized in certifications. Now, we are proud to announce that we have received our first EU MDR certificates,” says Karl-Yngve Keck, Senior Advisor Management Systems at Getinge.
In 2020 to 2021, Getinge will continue the program to ensure that the remaining selected manufacturing sites reaches compliance with the new law in good time before it is fully effective.
“This is very important for us in order to secure continued deliveries of our products into the EU market and into other markets dependent on the CE-mark,” says Mikael K Johansson, Senior Director Program Office Acute Care Thearapies & EU MDR at Getinge.