”Intendeduseofthedevice”wasreplacedby”Intended purposeandotherindications”inpoint2. Page2of10 MedicalDevices MedicalDeviceCoordinationGroupDocumentMDCG2022-9Rev.1 Regulation(EU)2017/746oninvitrodiagnosticmedicaldevices(theIVDR)requires thatthemanufacturershalldrawupasummaryofsafetyandperformance(SSP)for class...
Please note that it may be justified by the manufacturer that an SSCP/SSP may not need to be sent to the Notified Body for validation if the safety or performance information of the device remains unchanged and there is no new helpful information for the healthcare professional/patient/user. ...
2021 ANNUAL REPORT SUMMARY 01 IMPORTANT NOTES 02 2021 Annual Report Summary Important Notes This annual report summary is extracted from the full text of the annual report. Investors who wish to understand the operating results, financial conditions and future development plan of the Company should ...