The New Approach Directives are a series of legislative requirements that ensure product safety within the EU market across a range of products and devices.
Medical devices and healthcare auto
New list of harmonized standards for medical devices
In January 2015, the EU Commission published a new list of standards for medical, in-vitro, and implantable devices on the EU market.
Progress on upcoming regulations on Medical Devices
EU Council report shows progress on proposed new medical device and in-vitro diagnostic device regulations to replace previous European directives.
Transatlantic Trade and Investment Partnership: Steps towards faster access to Medical Devices
Recent reports suggest that the Transatlantic Trade and Investment Partnership may likely lead to easier circulation of medical devices between the EU and USA.
New EU Rapporteur for the Medical Devices Revision Package
In September 2014, the EU Parliament appointed UK Labor Party member Glenis Wilmott as new rapporteur in ongoing medical device legislation revision.
New version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices
New version of EU Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices published in September 2014.
Formula Verification Service
European regulatory and compliance experts Obelis announce new formula verification service for manufacturers starting the EU compliance process.
EU Medical Devices Legislation – An Update
New information on the progress and delays to new proposed EU medical device legislation from Europe's leading regulatory and compliance experts.
Irish Authorities restructure
From July 2014, the national Irish medical and cosmetics regulator, Health Products Regulatory Authority, will become known as the Irish Medicines Board.
Italy Decree on online registration of IVDs!
Italy enacts decree requiring in-vitro diagnostics device manufacturers with devices on the Italian market to register products with health ministry database.