Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.
IVD’s
Extended IVDR legacy period officially published
On 9 July 2024, the Official Journal of the EU published Regulation (EU) 2024/1860, amending the medical devices Regulations (MDR and IVDR). This introduces an extended legacy period for IVDs, effective immediately.
European Parliament votes in favour of new IVDR legacy period and EUDAMED roll-out plan
Stay informed on upcoming cosmetic regulatory changes. Learn about the deadlines and new requirements for compliance in 2024.
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.
Main regulatory developments to follow in 2024
Find out the 2024 updates regarding Medical devices, In-Vitro diagnostics, cosmetics, construction products, toys and more!
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).
3 tips to obtain IVDR certification
The EU IVDR (Regulation on in-vitro diagnostic devices) applies as of May 26, 2022, profoundly…
What are the documents needed to comply with IVDR and UK IVD?
Regardless of type of IVD, there are certain common requirements to place your device on…
The Road to IVDR Compliance in Europe
Welcome to the realm of In Vitro Diagnostic Devices Regulation (IVDR) in Europe. As the…
5 things to know about EUDAMED registration
Covering the whole European Union, EUDAMED (European database for medical devices) is the European Commission’s…