The EU medical device regulation has created a new category known as 'Aesthetic Devices'. These are defined as devices “without and intended medical purpose”.
Medical devices and healthcare
EC identified essential principles in REACH data-sharing
REACH data-sharing principles define terms of transparency, non-discrimination, and fairness for chemical substance registration.
What is RAPEX
The RAPEX database was created as an alert system for EU product compliance issues. Learn more about how it works and its role in general EU market vigilance.
What is a Medical Device according to MDD 93/42/EEC?
Understanding the definition of a medical device as outlined by European Medical Device Directive 93/42/EEC. Talk to Obelis for more EU compliance information.
Obelis Launches a Bulgarian National Registration Service
Obelis launches new registration and EAR service for non-EU manufacturers seeking to introduce medical and in-vitro diagnostic devices on the Bulgarian market.
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.
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.
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.
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.