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.
Obelis attends GLAM Consortium Meeting
Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, and Senior Regulatory Expert, Mrs. Louise Olliver, attended…
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.
New Medical Devices & IVD Regulations adopted by the European Parliament
On 5th April 2017 the EU Parliament officially adopted two new regulations concerning medical devices and in-vitro diagnostics devices.
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.