The European Commission has published the catalogue of nanomaterials used in cosmetic products, on the market. Find out what this catalogue indicates.
News
The role of distributors under the new Medical Device Regulation
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.
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
Cosmetic Preservatives – What Changed ?
Recently many preservatives have been banned or restricted in cosmetic products. One of the most widely used was the mixture Methylchloroisothiazolinone / Methylisothiazolinone (MCI / MI). This mixture was allowed for use in all cosmetic products up to 0,0015% (3:1). This is no longer the case. Read the major changes of the cosmetics preservatives here.
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.
ECHA Launches Public Database of Chemical Substances
Discover the fundamental characteristics of the publicly accessible database of the European Chemical Agency (ECHA) on over 15 000 chemical substances.
Obelis attends GLAM Consortium Meeting
Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, and Senior Regulatory Expert, Mrs. Louise Olliver, attended…
It is official: New EU MDR & IVDR enter into force
The new European Medical Device Regulation and In-Vitro Diagnostics Devices Regulation will come into effect from May 25th, 2017. Learn about them with Obelis.
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.