On 5th April 2017 the EU Parliament officially adopted two new regulations concerning medical devices and in-vitro diagnostics devices.
Medical devices and healthcare auto
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.
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.
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.
EU to release NEW Medical Device Regulations!
In June 2016 the EU Parliament released proposals for new Medical Device and In-Vitro Diagnostics device regulations applicable to all EU member states.
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”.
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.