MHRA IVD Advice Update 🏆
On June 22 2021, the guidance “Notify the MHRA about a Clinical Investigation for a Medical Devices” by the MHRA was updated to include information on clinical trials where the clinical performance of an IVD is not yet demonstrated.
Important points include:
- At clinical trial application, where the performance hasn’t been demonstrated, the CE / UKCA / CE UKNI need only exist for the analytical performance of the IVD, including reagents, equipment, calibrators and software
- All IVDS put on the UK market will need to have CE, UKCA, or CE UKNI conformity assessment marking (except for certain exceptions, see site for more)
- Trials to determine clinical performance of an assay will need to be included in performance studies
đź”— https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
#MDRG #mdrguide #IVDR #MHRA # IVD #mdr #medicaldevices #ec
