To comply with the EU Medical Devices Regulations (MDR and IVDR), an important deadline is approaching for labels of medical devices and IVDs. From 26…
New MDCG Guidance on Master UDI-DI for contact lenses
The Medical Device Coordination Group (MDCG) just published a new MDCG guidance document on the implementation of the Master UDI-DI solution for contact lenses. MDCG…
New MDCG Guidance on IVDR legacy requirements and Q&A on UDI!
The Medical Device Coordination Group (MDCG) has released two very useful guidances: one concerning the application of IVDR requirements to “legacy devices” and devices placed…
MDCG Guidance note: UDI within organization’s QMS
The MDCG has released a new Guidance note on how to implement the MDR / IVDR requirements related to the Unique Device Identification (UDI) system…