The responsibilities and role of the EU Authorised Representative (or EC Rep) is now in the spotlight as a result of the UK’s decision to leave the EU. Many companies have previously chosen EU Authorised Representatives from the UK and, as a result of the referendum, will now need to choose a new representative within the EU. In […]
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.
We are growing at a rapid pace at Acorn Regulatory. Right now, we are seeking to hire a Medical Devices Regulatory Affairs Advisor with experience in the medical devices sector.
The UK’s impending departure from the EU will necessitate a change in designated EU Authorised Representatives for companies that are currently using a UK based authorised representative at present. This will cause considerable upheaval and disruption to companies using such a service. The consensus view that Britain will seek to leave using a hard Brexit […]
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.