If you are unsure of how you should now proceed in order to import new devices or maintain the previous ones in the European territory, this webinar is what you were looking for! Register now!
Medical devices and healthcare auto
Obligation on icons and symbols to display for manufacturers of medical devices
In January 2022, the Journal of the European Union published harmonised standards for medical and health care products, including symbols that manufacturers must provide for their products. Read all the details!
EUDAMED Challenges: Actor & Device Registration
Join our latest Webinar about EUDAMED. Sandra Ferretti, CCO at Obelis Group will walk you through all the challenges related to Actor and Device Registration!
What is the Common list of COVID-19 rapid antigen tests?
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!
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…
EU Circular economy: how to address the problem of increasing electrical and electronic waste
Within the model of the EU circular economy, the economic operators have to comply with the WEEE Directive. Discover all the details in our article!
Obelis Group acquires SYNC Projects Ltd.
In February 2022, Obelis Group acquires SYNC Projects and expands its operations to the Israeli market, securing compliance in a new territory.
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!