Stay informed on upcoming cosmetic regulatory changes. Learn about the deadlines and new requirements for compliance in 2024.
Medical devices and healthcare
How to prepare for the proposed extension for IVD medical devices
The EU’s proposed extension for IVD medical devices aims to prevent shortages. Manufacturers must prepare by meeting IVDR requirements promptly.
Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations
Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations
Main regulatory developments to follow in 2024
Find out the 2024 updates regarding Medical devices, In-Vitro diagnostics, cosmetics, construction products, toys and more!
Webinar: MHRA and Clinical Testing (with the collaboration of Qmed Consulting A/S)
Watch our new webinar about MHRA and Clinica Testing with the Qmed Consulting A/S
New Free Sales Certificate under MDR & IVDR for EU non-EU manufacturers!
The Belgian competent authority (AFMPS/FAGG) has updated the form for the Free Sales Certificates (FSC) under the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR).
Facility registration under MoCRA: who has to register and how to do it
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
Good manufacturing practices (GMP) for cosmetic producers explained
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
Understanding MoCRA: how to obtain a safety substantiation in the US
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
From FDA facility registration to US Agent: MoCRA step-by-step for the European cosmetic industry
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).