Guidance on the vigilance system for CE-marked devices and the Device Specific Vigilance Guidance (DSVG) Template
This newsletter is aimed toward introducing the Device Specific Vigilance Guidance (DSVG), a pivotal document aimed at harmonsing vigilance reporting and offering comprehensive gui
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
New EU IVD Regulations, Potentially In Line with Australian IVD Requirements
The European Commission is considering a number of key requirements, namely classification rules and clinical evaluation, for inclusion in the new IVD Regulation which will be pote
New MEDDEV Documents Released
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
EU publish much awaited draft regulation for e-labelling of medical devices
The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into fo
TGA Release Update Regarding Proposed Regulatory Framework Reforms
The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into fo
