The European Commission (EC), the EU regulating authority in the sphere of medical devices, has published a document describing the regulatory requirements under the MDR EUDAMED framework. Regulatory Background The new guidance published by the European Commission...
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document dedicated to the in-vitro diagnostic (IVD) point-of-care test devices. Aside from other aspects, the...
The Food and Drug Administration (FDA) has published a guidance document dedicated to the patient-reported outcome measures and the way they should be used in medical product development to support labeling claims. Together with the Patient Preference Information...
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the labeling rules for medical devices introduced by the...
The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has published guidance dedicated to the medical device stand-alone software including applications. The scope of the guidance covers standalone software and applications intended to be marketed...