The EU medical device regulation has created a new category known as 'Aesthetic Devices'. These are defined as devices “without and intended medical purpose”.
Consumer goods
Authorized Representative: Higher Liability affecting Agreement
Find out the most fundamental aspects to understand when working with a European Authorized Representative.
EC Issues Comprehensive Paper on Nanomaterials
European Commission issue comprehensive paper on the functionality and safety of nanomaterials in cosmetics for human use. Learn more with Obelis.
What are the New Approach Directives?
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.
The ecological criteria for the award of the EU Ecolabel for rinse-off cosmetic products
More info on required criteria for awarding the Ecolabel to rinse-off cosmetic products within the EU-a voluntary label promoting environmental excellence.
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.
Formula Verification Service
European regulatory and compliance experts Obelis announce new formula verification service for manufacturers starting the EU compliance process.
Annex II of Toy Safety Directive amended by EC!
Updates to the EU Toy Safety Directive provide specific limits on TCEP, TCCP, and TDCP chemical in toys placed on the EU market. Read more with Obelis.
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.