EU regulatory experts explain the Unique Device Identification (UDI) system and what it means for you under EU Medical Device Regulations 2017/745 and 2017/746.
Medical devices and healthcare auto
EU – USA Cooperation in Medical Devices
Europe and US set to work together to reduce barriers and increase trade in medical products. Cooperation could reduce manufacturing costs and improve controls.
Upcoming event: RMD + CRCC 2019 in Brussels
Obelis invites you to its 4th ERPA Annual Congress on Regulations and Compliance for Cosmetics and EAAR Annual MDR Conference on October 28-29, 2019.
European Commission Expert Panels on Medical Devices and In Vitro Diagnostic Devices
The European Commission called for the creation of expert panels to advise and support on new EU medical device and in-vitro device regulations.
MDCG released Guidance on the role of the Person Responsible for Regulatory Compliance (PRRC)
Medical Devices Coordination Group have issued guidance on the new role of the EU Responsible Person under EU medical device and in-vitro device regulations.
New Borderline and Classification Manual published
The European Commission have published a new Borderline and Classification manual to accompany new medical device and in-vitro device regulations.
UDI designating entities: EU Commission implementing decision released
An implementation decision has been published listing the entities designated to operate the Unique Device Identification (UDI) system for EU medical devices.
Person Responsible for Regulatory Compliance. A star is born!
Person Responsible for Regulatory Compliance: unveiling its meaning and role under the MDR.
The Basic GMDN membership is made available as a free service
Global Medical Device Nomenclature agency have announced basic membership as a free service to all users. Find out how to join and how it works.
French Competent Authority bans various types of breast implants linked to cancer
French competent authority Agence Nationale de Sécurité de Médicament et des Produits de Santé ban breast implants linked to anaplastic large cell lymphoma.