The new EU IVD regulation changed the classification system for in-vitro diagnostic devices in Europe. Learn more about the new risk-assessment based model.
News
New Medical Devices & IVD Regulations adopted by the European Parliament
On 5th April 2017 the EU Parliament officially adopted two new regulations concerning medical devices and in-vitro diagnostics devices.
Cosmetic Product Classification
In order to ensure a product is indeed a cosmetic product, the product formulation, characteristics, sites of application and intended functions must match the definition of a cosmetic product as defined in the scope of Cosmetic Regulation EC 1223/2009, which came into effect in 2013. Read about the cosmetic product classification.
EU Commission restricts the use of hair dyes and Benzophenone-3
What do the amendment to the current Cosmetic Regulation state? Read more about it here.
Obelis at Medica 2016
Obelis Group exhibited for the 13th consecutive year at Medica Trade Fair, one of the…
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.
Red and Blue Light Therapy Devices and EU Compliance
Medical Device Regulation 2017/745 defines light therapy devices as 'Aesthetic Devices' and outlines a number of compliance requirements they must adhere to.
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.
What Needs to be Translated on a Cosmetic Label?
Learn more about the EU's specific cosmetics product labelling requirements and which elements must be translated for each EU member state.
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