The Unique Device Identifier system and codes have been introduced to Europe under the new medical device and IVD regulations. Find out more with Obelis.
Other Industries
Borderline Cosmetics – Toys Products: How to Comply?
How should you apply EU Cosmetics Regulations and Toys Directives to products classified as borderline? Find out with clear regulatory advice from Obelis.
The future role of Eudamed
Given new importance by the upcoming EU regulations, the EUDAMED database will provide vital info to industry bodies on medical devices in Europe.
Catalogue of nanomaterials finally published!
The European Commission has published the catalogue of nanomaterials used in cosmetic products, on the market. Find out what this catalogue indicates.
Last call to be compliant with the new Radio Equipment Directive 2014/53/EU
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
The New Clinical Trial Regulation & Its Benefits
The new Clinical Trial Regulation will change the way trials are conducted in Europe and harmonise assessment/supervision processes for European member states.
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.
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.