Obelis launches new registration and EAR service for non-EU manufacturers seeking to introduce medical and in-vitro diagnostic devices on the Bulgarian market.
News
European Commission investigates the safety of Metal-on-Metal hip implants
Read more on the Scientific Committee on Newly Identified Health Risks' opinion on the use of metal-on-metal health implants and their potential risks.
New Harmonized Standards on R&TTE
EU publishes new harmonized standards for Radio and Telecommunication Terminal Equipment in Europe. Talk to Obelis to find out how they may affect your product.
Rapex
The Rapid Alert System (RAPEX) is an EU-wide vigilance platform for general products. Learn more about what it is and what it does with Obelis.
OEM Manufacturers – Obtain your own CE Marking!
Obelis can help Original Equipment Manufacturers and Original Brand Labellers obtain CE marking for their products. We can help you get yours today!
ISO 9001:2015 – A New Approach!
ISO 9001:2015 aims to increase quality and risk management standards globally. Manufacturers will have three years to update current compliance certification.
What is the compliance path for EMC & LVD products?
What is the compliance path for EMC & LVD products when trying to bring a wide range of products to the European market? Read on the compliance process here
New List of MDD Harmonized Standards Published by the European Commission
Talk to Obelis for more information on the new list of medical device harmonized standards published by the European Commission under Directive 93/42/EEC.
The Court of Justice Rules: Contact Lenses Do Not Fall Under the Cosmetics Regulation
European Court of Justice rule that contact lenses do not fall under the scope of new cosmetics regulation 1223/2009.
French Court of Appeal clears Notified Body Liability in PIP breast implant case
Aix-en-Provence Court of Appeal in France clear Notified Body TÜV Rheinland of liability in PIP breast implant scandal case.