A new series of regulatory and compliance guidelines for Original Brand Labelers working with medical and in-vitro diagnostic devices have been introduced.
Other Industries
My product has been found to be non-compliant – now what?
Understanding the process for products that have been found to be non-compliant with EU Cosmetics Regulation 1223/2009 and the consequences of non-compliance
Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of September 2016 in Galway, Ireland. The event, co-organised by Dr James J. Browne, the President of NUI Galway and Professor Abhay Pandit, the director of CURAM, brought together world-class academic, medical devices industry and clinical partners.
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.
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.
New Harmonized Standards on R&TTE
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.