The EU’s proposed extension for IVD medical devices aims to prevent shortages. Manufacturers must prepare by meeting IVDR requirements promptly.
IVD’s
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 In-Vitro Diagnostic Regulation (IVDR) has applied since May 26, 2022, significantly changing regulatory…
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…
Do you know the requirements for IVD legacy devices to be marketed on the EU and UK markets?
80% of IVDs devices that did not need to involve a notified body under the…
IVDR Compliance towards Korean/Chinese manufacturers
As an IVD (In Vitro Diagnostic) Korean manufacturer, accessing the EU (European Union) market can…
How to select a Notified body for your in vitro diagnostic medical devices?
Most in vitro diagnostic medical devices require the involvement of a notified body or approved…