A new series of regulatory and compliance guidelines for Original Brand Labelers working with medical and in-vitro diagnostic devices have been introduced.
Medical devices and healthcare
Obelis to hold EROMED seminar at MEDICA 2016
Obelis Group will hold an EROMED seminar at the MEDICA trade show, taking place from the 14th November till 17th November in Messe Düsseldorf, in Germany. The seminar, which is entirely free of charge, will be conducted at the Obelis booth (Hall 17, Stand D59), every day at 11 am and 3 pm. It will focus on the new proposal on EU legislation on Medical Devices and its impact on the compliance path and the CE marking process.
Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of September 2016 in Galway, Ireland. The event, co-organised by Dr James J. Browne, the President of NUI Galway and Professor Abhay Pandit, the director of CURAM, brought together world-class academic, medical devices industry and clinical partners.
What is the CPNP?
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.
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”.
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.