The Cosmetics Products Notification Portal was created under EU Cosmetics Regulation 1223/2009. Find out what it is, what it does, and how it works.
Medical devices and healthcare auto
Aesthetic Products Under New Medical Device Regulation
The EU medical device regulation has created a new category known as 'Aesthetic Devices'. These are defined as devices “without and intended medical purpose”.
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.
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.
MHRA issues a Draft Guidance on the Re-Manufacturing of Single-Use Devices
On July 20th 2015, the Medicines & Healthcare Products Regulatory Agency issued draft guidance on the re-manufacturing of single-use devices on the UK market.
European Court of Justice to Clarify Liability for Medical Device
The European Court of Justice, by request of Germany's Federal Supreme Court, will clarify the liability of notified bodies in relation to medical devices.