Discover the list and scope of new devices covered by EU in-vitro diagnostics device regulation 2017/746, in effect from April 2017.
News
Cosmetic claims and labelling under scrutiny
Compliance of claims and labelling of cosmetic products are under scrutiny – according to the recent market reports, there are far too many cosmetic products released on the market that do not comply with the EU legislation on this matter.
The future role of Eudamed
Given new importance by the upcoming EU regulations, the EUDAMED database will provide vital info to industry bodies on medical devices in Europe.
Catalogue of nanomaterials finally published!
The European Commission has published the catalogue of nanomaterials used in cosmetic products, on the market. Find out what this catalogue indicates.
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
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.
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.