Cosmetic Products Notification Portal 1.5 update features new functions for Responsible Persons including product transfer and downloading capabilities.
Consumer goods
Why Don’t Retailers Request Proof of Compliance?
The burden of proof for EU compliance falls on manufacturers throughout all market segments. Learn more about your obligations from Obelis' EU regulatory team.
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.
Eu Council agrees on a General Approach for Medical Devices and IVDs Regulations
The Council of the European Union has agreed on a general approach to new medical and in-vitro diagnostic device regulations to be finalized by the end of 2015.
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From April 2016, low voltage directive 2006/95/EC will be repealed by the new 2014/35/EU LVD.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.