Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations
Medical devices and healthcare
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).
MoCRA Facility Registration Requirements
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).
EU Regulations on Medical Devices and IVD medical devices: What is the mandate and when do manufacturers need it?
Non-EU manufacturers can sell medical devices on the European Union market only if they appoint an authorised representative (EAR). Read more!
What is a PLIP and why is it required under MDR?
Article 10 (16) of the MDR obliges the manufacturer to have sufficient financial coverage for potential liability of defective medical devices. Read more!