From April 2016, all products falling under the scope of EU Radio Equipment Directive RED 2014/53/EU must be within full compliance or face market penalties
Consumer goods
New Medical Devices & IVD Regulations adopted by the European Parliament
On 5th April 2017 the EU Parliament officially adopted two new regulations concerning medical devices and in-vitro diagnostics devices.
Period After Opening Vs Expiration Date
Understand the difference between Period After Opening and Expiration Date under EU Cosmetics Regulation EC 1223/2009 with Obelis' EU regulatory experts.
Updated Quality Management Requirements for OBL Manufacturers
A new series of regulatory and compliance guidelines for Original Brand Labelers working with medical and in-vitro diagnostic devices have been introduced.
What is the CPNP?
The Cosmetics Products Notification Portal was created under EU Cosmetics Regulation 1223/2009. Find out what it is, what it does, and how it works.
Updated version of the EU “Blue Guide” published!
The EU Commission has published an updated 'Blue Guide' on the implementation of the product rules of each CE marking directive and regulation.
Heavy Metals in Cosmetics
The use of heavy metals in cosmetic products has always been a complicated issue around the world and remains so to this day. Get more information on this topic
Liability affecting Agreement
Obelis' EU regulatory experts help you understand more about new obligations and liabilities under the new European Authorized Representative system.
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”.
What is RAPEX
The RAPEX database was created as an alert system for EU product compliance issues. Learn more about how it works and its role in general EU market vigilance.