Understanding claims criteria and best practices for cosmetics products according to EU cosmetics regulation 655/2013: guidelines, compliance points, and more.
News
Merger of Belgian IVD & MD authorities
Belgian medical and in-vitro diagnostic competent authorities merged in September 2017 for increased surveillance and traceability in devices on the EU market.
Registering Cosmetic Products in Spain
What is the process of registering cosmetic products in the Spanish market.
Medical apps under the new European MDR
Exploring the differences and between medical and well-being apps under the scope of EU medical device regulation 2017/745 and their legal requirements.
The new CE marking process for the Low Voltage Equipment
The new European Low Voltage Directive (LVD 2014/35/EU) outlines a new CE marking process for equipment on or to be introduced to the EU market.
(P) Steps to obtain CE Marking for your PPE 89/686/EEC Directive Products
Develop a roadmap towards obtaining a CE mark and compliance program for your PPE with Obelis' European Authorized Representative services.
The importance of GMDN Codes
According to the European Commission decision from 19th April 2010, uploading data into EUDAMED requires the use of GMDN codes. Read more on this topic.
New EU Borderline and Classification Manual on Medical Devices
A manual has been published on borderline products and classification under EU medical device regulation 2017/745. It contains guidance on harmonised standards.
New European Notified Body Product Codes Open for Consultation
Public consultation has been opened on the implementation of the new notified body product codes under the oncoming EU medical device and IVD regulations.
Switzerland harmonizes Cosmetics Regulation with EU’s
Under Project LARGO, Switzerland has overhauled its food and consumer product regulations, harmonizing them with current EU laws and standards.