Rapid antigen tests are widely used in the European Union and are helping to strengthen many countries testing capacities. For more information visit our page!
Notified body
EU list of recommended antigen COVID-19 test replaces Belgian list
Antigen tests are IVDs of class D under the IVDR. This means that they will fall under the highest-risk category of IVDs, needing a Notified Body involvement.
Obelis Roundtable on IVDR: How to get ready?
While every In Vitro Diagnostics brand journey, mission and merchandise are different, the regulatory compliance…
What are expert panels for medical devices and IVDs?
The introduction of the new Regulations on medical devices in the European Union meant stricter controls and reinforced rules on transparency and clinical evidence. Learn more!
LIVE Roundtable: IVDR is coming- how to get ready!
Don’t miss this unique opportunity to learn suggested strategies and best practices that lead to successful IVDR transition and outcomes!
Shortage of medical and protective equipment: EU strategies to prevent market disruptions
The elimination of barriers and the introduction of free movement of goods, services, and people across the Member States have granted a more dynamic business environment. To learn about the consequences of these new changes visit our page!
Toys containing aqueous media: New Revision of Protocol on Microbiological Safety
This protocol provides a specification of the microbiological requirements on toys covered by its scope and since there are no particular microbiological requirements for toys, the Notified Body toys group elaborated a protocol on the basis of the requirements for cosmetic products. Read more..
Shaping the future of the EU market. The legislative framework for industrial products under revision
In 2008, the European Parliament and the Council jointly adopted the Decision No. 768/2008/EC aiming to set a common framework for a new Industrial Policy. Read more
IVDR: What are EU Reference Laboratories (EURLs)?
With the In Vitro Diagnostic Medical Devices Regulation (IVDR), the IVD sector in the European Union is about to experience significant changes. From a new classification system to stricter assessment procedures and market surveillance. Read the full article to discover all the details!
HPRA 2020 Annual Report
Each year, Health Products Regulatory Authority (HPRA) publishes the annual report outlining its activities in the area of public and animals’ health. The Irish agency’s new report was published on November 20, 2021, and summarises last year’s programs development to regulate health products and the safety of cosmetics. Read the full article to know more!