The Obelis team visited Last Vegas in July 2018 to deepen relationships with clients, work on upcoming projects, and attend Cosmoprof North America.
News
New references of harmonised standards
New references of EU harmonised standards published for personal protective equipment, machinery, ATEX, construction points, pressure equipment, and more.
New amendments to the Cosmetics Regulation
European Commission issue statement on updates to Annexes VI, II, III, and V of new EU Cosmetics Regulation 1223/2009 and the substances banned by it.
CAMD and MDR/IVDR transitional provisions
CAMD aim to provide guidance on transitional provisions for manufacturers of medical devices and in-vitro devices under the new EU regulations.
To What Extent Should You Investigate a Medical Device Complaint?
There are no predefined rules in determining to what extent a manufacturer should investigate a medical device complaint, but there are several key facts and questions that may be used as a guidance. Read on this topic here.
General Data Protection Regulation – scope and main changes
Useful information on the scope and main changes introduced under the new European General Data Protection Regulation, entering into force in May 2018.
Switzerland is aligning the medical devices legislation to the future EU Regulations
Switzerland aligns with EU medical device legislation to make crucial improvements to patient and consumer safety. The country expects to be aligned by 2020.
New Electronical Apostille system from the Belgian Ministry of Foreign affairs
The Belgian Ministry of Foreign Affairs' new electronic apostille system for Free Sales Certificates will have a positive impact on legalization timeframes.
Ex-vivo tests: cosmetics without human testing
Find out more information on the European Directive increasing the safety requirements for cosmetic products.
The “sell off” provision under the MDR and IVDR
The EU Competent Authorities for Medical Devices (CAMD) have recently released their FAQs to provide guidance on certain specific aspects concerning MDR/IVDR transition-related provisions.
Read more about it here.