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
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 […]
Last week, in the first part of this series, we outlined the post-market obligations for Manufacturers under the European IVD and medical device directives. In the second part of this series we are going to discuss another post-market topic – change control. Much as quality and regulatory peoples’ lives would be made easy, if, once a […]