The European Parliament has endorsed the new InVitro Diagnostic Medical Devices (IVDR) and the new Regulation on Medical Devices (MDR) at a sitting today (April 5th 2017). The long awaited final vote is the last step in an almost 8-year process to update the legislation that was first written in the 1990’s.
Search Results for: medical device regulations
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may […]
We’re looking at the 5 most read medical device news stories from AcornRegulatory.com for the past 12 months. What a year we have had globally.
Acorn Regulatory has published a whitepaper looking at the potential implications of Brexit on a number of healthcare sectors. The document looks at the impact of the UK’s decision to leave the EU on institutions such as the EMA. It also focuses on the EU’s Medical Device Directive and the regulations surrounding clinical trials. Speaking at […]
In this article we are look at the seven key changes to the In Vitro Diagnostic Medical Device regulations. In vitro diagnostic medical devices (IVDs) cover a wide range of products that can be used for diagnosis, therapeutic drug monitoring, disease screening, assessment of medical interventions and population screening. Manufacturers of IVDs need to comply with […]