One of the key requirements towards cosmetic products is their safety for human health. Find out what evaluates the stability testing.
News
New Responsibilities of EAR under the new MDR
Learn more about the new responsibilities set in force in May 2017 for European Authorized Representatives under EU medical device regulation 217/745.
Additional requirements in the EMC Directive 2014/30/EU
Find out more about new manufacturer requirements and obligations under recent EU EMC directive 2014/30/EU. Talk to our regulatory experts about compliance.
The new EU UDI codes for Medical Devices
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.
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.
France’s new adverse reporting portal for cosmetics
Discover what's an adverse health related event, and the new portal for cosmetics.
The new South African Health Products Regulatory Authority (SAHPRA)
The South African government has formed an independent, state-owned agency, SAPHRA, to oversee medical device and pharmaceutical regulatory systems.
Certain Eyelash Dyes to be allowed in Cosmetics for Professional Use
The EU Commission has decided to follow the Scientific Committee on Cosmetic Products and Non-Food Products and to allow the use of eyelash dyes in cosmetic products for professional use.
Overview of CE Certification in 2016
Team NB, The European Association of Notified Bodies, released a summary of the Medical Device Sector survey. It gives insight into the number and types of CE and ISO certificates issued or withdrawn for Medical Devices, In-Vitro Diagnostic Devices and Active Implantable Medical Devices in 2016. Team NB assembles 22 European Notified Bodies, such as (among others): TUV, SGS or BSI.
New EU MDR: no grandfathering rule
New European medical device regulation 2017/745 installs new 'no-grandfathering' rule to encourage conformity assessment and compliance throughout EU market.