EU vote confirms cranberry products are not medical devices. This is the first borderline product ruling adopted based on MDD 13(1)(d).
Other Industries
New limits for BPA in toys
New EU Commission Directive 2017/898 is set to enforce higher restrictions on Bisphenol A (BPA) in toys in the interest of consumer safety in Europe.
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.
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.
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.
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.