Learn about the new Article 10a under EU MDR and IVDR, requiring manufacturers to notify authorities and stakeholders of potential medical device or IVD supply interruptions. Understand the scope, notification process, and exemptions, as well as how to comply with these regulations to ensure patient safety and continuity of care.
Distance sales devices, sold through online platforms, must meet specific regulations outlined in Article 6 of the MDR and IVDR to ensure safety and performance. This includes devices used for remote healthcare services, even if not directly sold within the EU.
Discover how the EU and Switzerland maintain strong trade relations through mutual regulation agreements, enabling smoother market access for many products.
To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.
Stay informed on upcoming cosmetic regulatory changes. Learn about the deadlines and new requirements for compliance in 2024.
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
Find out the 2024 updates regarding Medical devices, In-Vitro diagnostics, cosmetics, construction products, toys and more!
Watch our new webinar about MHRA and Clinica Testing with the Qmed Consulting A/S
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).