The South African government has formed an independent, state-owned agency, SAPHRA, to oversee medical device and pharmaceutical regulatory systems.
Medical devices and healthcare auto
Overview of CE Certification in 2016
Team NB, The European Association of Notified Bodies, released a summary of the Medical Device Sector survey. It gives insight into the number and types of CE and ISO certificates issued or withdrawn for Medical Devices, In-Vitro Diagnostic Devices and Active Implantable Medical Devices in 2016. Team NB assembles 22 European Notified Bodies, such as (among others): TUV, SGS or BSI.
New EU MDR: no grandfathering rule
New European medical device regulation 2017/745 installs new 'no-grandfathering' rule to encourage conformity assessment and compliance throughout EU market.
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…
It is official: New EU MDR & IVDR enter into force
The new European Medical Device Regulation and In-Vitro Diagnostics Devices Regulation will come into effect from May 25th, 2017. Learn about them with Obelis.
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.