RetInSight receives EU Quality Management System certificate according MDR 2017/745

RetInSight, a leader in AI-assisted retinal biomarker image analysis, has received its EU Quality Management System certificate according MDR 2017/745 on December 13, 2021.

RetInSight’s Quality Management System including product and technical documentation meets all required EU regulations to develop and market its class IIa medical device software for the diagnosis and monitoring of retinal disease using images available on commercially ophthalmic diagnostic instruments. RetInSight is currently the only MDR certified manufacturer to offer AI-based OCT image analysis.

On May 26th, 2021, the new “Regulation (EU) 2017/745” (MDR) came into force replacing the older “Medical Device Directive 93/42/EEC”. The new regulation is intended to make the EU legislative framework more vigorous and more consistent with other global regulatory requirements focusing on better protection of public health and patient safety. Not only is this new regulation aimed at facilitating patients’ access to devices in the European market in a highly consistent and regulated manner, but it also provides manufacturers with detailed information on meeting the requirements, especially when it concerns safety and efficacy of medical devices.

“The MDR certificate demonstrates that RetInSight fulfils all regulatory requirements from the EU regulation 2017/745. This allows RetInSight to develop and market medical device software class IIa for ophthalmology in the EU”, says Thomas Grundnig, Head of Quality and Regulatory Affairs, RetInSight.


RetInSight GmbH
Elisabethstraße 13/1/13
1010 Vienna, Austria
+43 (0)1 5813 881

The sender takes full responsibility for the content of this news item. Content may include forward-looking statements which, at the time they were made, were based on expectations of future events. Readers are cautioned not to rely on these forward-looking statements.

As a life sciences organization based in Vienna, would you like us to promote your news and events? If so, please send your contributions to news(at)