EU New Medical Device Regulation 2016
As of 1 July 2024, new regulatory requirements for medical devices containing medicinal substances, or materials derived from animal, microbial, or recombinant sources will take ef
The New EU MD Regulations on Notified Bodies. Will They Affect Australian Manufacturers?
In September 2012, the European Commission announced a proposal for regulation changes to medical devices and in vitro diagnostic medical devices. According to Medtech Insight News
Important Changes in the Regulatory Framework for IVDs
Goods new for laboratories that manufacture Class 4 in-house IVDs. A new conformity assessment procedure has been introduced.
