The updated Blue Guide was published in the Official Journal of the European Union towards the end of June. It includes updates concerning the implications of Brexit, Regulation (EU) 2017/745 & (EU) 2017/746 and more. We have only begun to pick through this new updated text and may have updates on our website in the weeks to come.
The Blue Guide has provided stakeholders in the EU important insight into some of the definitions and concepts used in EU Regulations, such as ‘placed on the market’. There are still areas that remain unclear; however, this document is an essential read for medical device manufacturers, importers, distributors and authorised representatives.
We at Advena Ltd in Malta remain at the disposal of new and potential clients to help navigate through the current regulatory landscape.
