The EU Commission has published an updated 'Blue Guide' on the implementation of the product rules of each CE marking directive and regulation.
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”.
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.
CPNP release 1.5 successfully deployed
Cosmetic Products Notification Portal 1.5 update features new functions for Responsible Persons including product transfer and downloading capabilities.
European Commission investigates the safety of Metal-on-Metal hip implants
Read more on the Scientific Committee on Newly Identified Health Risks' opinion on the use of metal-on-metal health implants and their potential risks.
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From April 2016, low voltage directive 2006/95/EC will be repealed by the new 2014/35/EU LVD.