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.
1010 Vienna, Austria
+43 (0)1 5813 881