Officially Here: EU Medical Devices And IVD Regulations Are Published
Executive Summary
After some five years of working on the EU's new Medical Devices Regulation and IVD Regulation, the texts that were finally adopted on April 5, have been published in the Official Journal of the European Union.
You may also be interested in...
UK MHRA Ensures There Is ‘No Avoiding' Usability Engineering
Changes the UK regulator has made to its guideline on human factors and usability engineering make the document more useful and realistic, and bring it in line with international standards, says a UK-based consultant.
EMA Plans Guidance To ‘Closely Knit’ Development Of Companion Diagnostics And Drugs
The European Medicines Agency has taken the first step towards the development of guidance to help optimize the co-development of medicinal products and companion diagnostics.
EMA Plans Guidance To ‘Closely Knit’ Development Of Companion Diagnostics And Drugs
The European Medicines Agency has taken the first step to develop guidance to help optimize the co-development of medicinal products and companion diagnostics.