New European medical device regulation 2017/745 installs new 'no-grandfathering' rule to encourage conformity assessment and compliance throughout EU market.
Medical devices and healthcare auto
NEW devices covered by the IVD Regulation
Discover the list and scope of new devices covered by EU in-vitro diagnostics device regulation 2017/746, in effect from April 2017.
The future role of Eudamed
Given new importance by the upcoming EU regulations, the EUDAMED database will provide vital info to industry bodies on medical devices in Europe.
The role of distributors under the new Medical Device Regulation
Learn more about the added roles and responsibilities of medical and in-vitro diagnostic device manufacturers under new EU regulations 2017/745 and 2017/746.
How to select a Notified Body?
Working with a notified body is a mandatory obligation under the EU new approach directives. But how do you select the right one for your devices? We can help.
What is changing for IVD Classification under the new IVD Regulation?
The new EU IVD regulation changed the classification system for in-vitro diagnostic devices in Europe. Learn more about the new risk-assessment based model.
Obelis at Medica 2016
Obelis Group exhibited for the 13th consecutive year at Medica Trade Fair, one of the…
Updated Quality Management Requirements for OBL Manufacturers
A new series of regulatory and compliance guidelines for Original Brand Labelers working with medical and in-vitro diagnostic devices have been introduced.
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.