Learn more about the added roles and responsibilities of medical and in-vitro diagnostic device manufacturers under new EU regulations 2017/745 and 2017/746.
News
How to select a Notified Body?
Working with a notified body is a mandatory obligation under the EU new approach directives. But how do you select the right one for your devices? We can help.
Last call to be compliant with the new Radio Equipment Directive 2014/53/EU
From April 2016, all products falling under the scope of EU Radio Equipment Directive RED 2014/53/EU must be within full compliance or face market penalties
The New Clinical Trial Regulation & Its Benefits
The new Clinical Trial Regulation will change the way trials are conducted in Europe and harmonise assessment/supervision processes for European member states.
What is changing for IVD Classification under the new IVD Regulation?
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.
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.