MHRA Updates Guidance on Legal Requirements for Specific Medical Devices
The MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices, including classification, custom-made devices and examples.
Swissmedic Publishes Updated Information Sheet on Medical Device Software (Version 3.0)
Swissmedic releases updated guidance on medical device software (MDSW), covering qualification, classification, and regulatory requirements under MDR/IVDR.
EU Borderline & Classification Manual (Version 5 – April 2026): What Manufacturers Need to Know
New EU Borderline & Classification Manual v5 (April 2026) published. Key MDR/IVDR qualification and classification examples for manufacturers.
MDCG Publishes Updated Guidance on Medical Device Classification (MDCG 2021-24 Rev.1)
MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.