Read more about the new restrictions on phenylene bis-diphenyltriazine, 2-chloro-p-phenylenediamine and climbazole in cosmetics products on the European market.
News
MDR and IVDR Corrigenda published by the EU
EU announce first corrigenda to medical and in-vitro device regulations. Some make formal changes while others amended content. Learn more with Obelis.
Can Safety Assessment be done in a lab outside of the EU?
The Safety Assessment procedure is an important part of the cosmetics compliance process. Find out if this can be done in a lab outside the EU.
‘Free from’ claims – clarification of application
Danish authorities ask for clarification on processes for 'free from' claims for cosmetics products on the European market.
Biocompatibility: MDR and EN ISO 10993-1:2018
What does the new standard on Medical Device Regulation say.
Third-Party Producers and the European Market
There are many things to consider when introducing a product to the European Market for the first time. Right at the top of that list is: What is the background of my third-party producer and are there any barriers to their components entering the market?
Cosmetic Products Regulation 1223/2009/EC Annexes update
European Cosmetics Regulation 2019/831 has been published. In effect, it amends Annexes II, III, and V of Regulation 1223/2009/EC.
1 YEAR UNTIL MDR APPLICATION: How to prepare for a transition to new requirements?
With 12 months to go until European Medical Device Regulation 2017/745 comes into effect in May 2020, we look at how to prepare your products for compliance.
Do I need a Responsible Person once my products are registered on the CPNP?
What are the duties of the Responsible Person, after the CPNP registration process and how do they influence the importance of the manufacturer's role?
Do I need an EAR if I have a Notified Body?
Though both are involved in the EU Compliance process and CE Marking, a European Authorized Representative and a Notified Body are not mutually exclusive bodies. Both have roles unique to themselves throughout the EU Compliance procedure. In order to clear up a few common misconceptions regarding European Authorized Representatives (EAR) and Notified Bodies (NB), this blog will outline the definitions and roles of each.