Obtaining an EC certificate confirming compliance with Directive 93/42/EEC for Medical Devices.

On May 20, 2021, the Company received the EC certificate – Full Quality Assurance System, Directive 93/42/EEC for Medical Devices, Annex II, excluding Section 4, for CARDIOVICE ECG Recorder and CARDIOVICE App devices, issued by the notified body TÜV Rheinland. 

By issuing the TÜV certificate, Rheinland declared at the same time that all requirements (with the exception of section 4 of Directive 93/42/EEC) have been met for the products cardiovice ECG Recorder, CARDIOVICE App. The manufacturer of Telemedical Innovations has established and applies a quality assurance system subject to periodic surveillance audits pursuant to Annex II, Section 5 of the abovementioned Directive.