EU publishes new harmonized standards for Radio and Telecommunication Terminal Equipment in Europe. Talk to Obelis to find out how they may affect your product.
Other Industries
Rapex
The Rapid Alert System (RAPEX) is an EU-wide vigilance platform for general products. Learn more about what it is and what it does with Obelis.
What is the compliance path for EMC & LVD products?
What is the compliance path for EMC & LVD products when trying to bring a wide range of products to the European market? Read on the compliance process here
French Court of Appeal clears Notified Body Liability in PIP breast implant case
Aix-en-Provence Court of Appeal in France clear Notified Body TÜV Rheinland of liability in PIP breast implant scandal case.
European Court of Justice to Clarify Liability for Medical Device
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.
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From April 2016, low voltage directive 2006/95/EC will be repealed by the new 2014/35/EU LVD.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.