The European Court of Justice, by request of Germany's Federal Supreme Court, will clarify the liability of notified bodies in relation to medical devices.
Other Industries
New Low Voltage Directive 2014/35/EU
From April 2016, low voltage directive 2006/95/EC will be repealed by the new 2014/35/EU LVD.
FDA vs. EU compliance under the new Medical Device Regulation
Explaining the difference between EU and FDA compliance under the new EU medical device regulation. Learn more about registration, notified bodies and more.
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.
Obelis Cosmetics, Exhibiting @ Cosmoprof Asia
Representatives from Obelis' European Responsible Person Center and EU regulatory team will be attending Cosmoprof Asia from November 12-14, 2014.
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.