In many ways, a CE Certificate is a passport to the European Market for any medical device. It provides definitive proof that manufacturers and their products adhere to all European compliance regulations and that all standards have been met at each stage of the production process. The certificate itself ensures only the highest quality, safest products reach the EU marketplace.
News
Calls for data on the potential toxicity of Styrene/Acrylates Copolymer, Sodium Styrene/Acroylates Copolymer and Colloidal Silver nanoparticles used in cosmetics products
The EC has called for data on the potential toxicity of styrene/acrylates copolymer, sodium styrene/acroylates copolymer and colloidal silver nanoparticles.
Is English Sufficient for my Instructions for Use?
Ensuring all relevant product information is communicated clearly is an extremely important part of the compliance and market entry process for medical devices. As a general rule of thumb, any information pertaining to the product and its intended use should be outlined in at least the native language of every country on the European Market it is being released to.
Can I use a CE Mark if I don’t sell in the EU?
In this blog, we will explore CE marking’s role, or lack thereof, in allowing a product access to the global market.
No need to be concerned about BPA, EFSA Confirms
European Food Safety Agency issue re-evaluation of BPA ban in EU cosmetics products. Evaluation finds no risk to health of consumers of any age group.
What are the New Approach Directives?
The New Approach Directives are a series of legislative requirements that ensure product safety within the EU market across a range of products and devices.
New list of harmonized standards for medical devices
In January 2015, the EU Commission published a new list of standards for medical, in-vitro, and implantable devices on the EU market.
The ecological criteria for the award of the EU Ecolabel for rinse-off cosmetic products
More info on required criteria for awarding the Ecolabel to rinse-off cosmetic products within the EU-a voluntary label promoting environmental excellence.
Fragrance ingredient found unsafe by SCCS
Scientific Committee of Consumer Safety issue opinion finding vetiveryl acetate unsafe for use in rinse-off and leave-on cosmetic products in the EU.
Obelis Cosmetics, Exhibiting @ Cosmoprof Asia
Representatives from Obelis' European Responsible Person Center and EU regulatory team will be attending Cosmoprof Asia from November 12-14, 2014.