More information on the cosmetics ingredients banned under new European Cosmetics Regulation 1223/2009. Ingredients include formaldehyde, D4, and quaternium-15.
News
Can I use my existing packaging for the EU Market?
A manufacturer's guide to labelling and packaging requirements for cosmetic products under EU regulations. Be sure your packaging is EU market-ready.
MDCG released Guidance on the role of the Person Responsible for Regulatory Compliance (PRRC)
Medical Devices Coordination Group have issued guidance on the new role of the EU Responsible Person under EU medical device and in-vitro device regulations.
Cosmetic Distribution or Compliance: What comes first?
Compliance leads distribution under EU regulation 1223/2009/EC. Build a clear compliance and CPNP notification roadmap for your cosmetic products with Obelis.
New Borderline and Classification Manual published
The European Commission have published a new Borderline and Classification manual to accompany new medical device and in-vitro device regulations.
Do I need a CE Marking if my OEM already has one?
Who is responsible for CE marking on products in the EU, the original equipment manufacturer or the original brand labeller? Both! Find out why with Obelis.
UDI designating entities: EU Commission implementing decision released
An implementation decision has been published listing the entities designated to operate the Unique Device Identification (UDI) system for EU medical devices.
Person Responsible for Regulatory Compliance. A star is born!
Person Responsible for Regulatory Compliance: unveiling its meaning and role under the MDR.
The Basic GMDN membership is made available as a free service
Global Medical Device Nomenclature agency have announced basic membership as a free service to all users. Find out how to join and how it works.
Annual Team-NB Survey: 30% increase in CE Certificates
The latest survey for medical device community on the status of valid/new/withdrawn CE Certificates as well as on the changes in the NB personnel.