Given new importance by the upcoming EU regulations, the EUDAMED database will provide vital info to industry bodies on medical devices in Europe.
Medical devices regulation (MDR)
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.
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.
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.
MEDDEV 2.7/1 – new guidelines on clinical evaluations
New EU Commission MEDDEV 2.7/1 outlines clear guidelines for manufacturers and notified bodies on how to conduct a clinical evaluation for medical devices.
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”.
FDA vs. EU compliance under the new Medical Device Regulation
Explaining the difference between EU and FDA compliance under the new EU medical device regulation. Learn more about registration, notified bodies and more.
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”.