Explaining the difference between EU and FDA compliance under the new EU medical device regulation. Learn more about registration, notified bodies and more.
Consumer goods
Aesthetic Products Under New Medical Device Regulation
The EU medical device regulation has created a new category known as 'Aesthetic Devices'. These are defined as devices “without and intended medical purpose”.
Authorized Representative: Higher Liability affecting Agreement
Find out the most fundamental aspects to understand when working with a European Authorized Representative.
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.
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.
New version of the Blue Guide 2014. What is new?
EC publishes revised Blue Guide on implementation of product rules to reflect modernization and harmonization of legislative framework for product marketing.