An interview with Samsara Vision about the different compliance steps and the process to launch their products in the market.
News
IVDR Webinar: Complying with the IVDR Legacy Requirements
Join our latest Webinar about IVDR. Davide Turchi, Manager of the Regulatory Affairs department at Obelis Group, will walk you through all the challenges related to Legacy Requirements!
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!
Solution for consumers and the environment: a common charger in the EU for all electronic devices
The European Commission(EC) proposed a revision of the Radio Equipment Directive 2014/53/EU in order to introduce a common charger for electronic devices and reduce waste. Read more!
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!
Green Transition to impose new obligations for manufacturers
The European Union has been focusing on sustainability to reach its goal of climate neutrality by 2050. Visit our page for more information!
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!
Webinar: Clinical Investigations
In this webinar, our top experts suggest strategies and best practices.
Restriction of the use of hazardous substances in electronics: what is next?
The European Union restricts hazardous substances in electrical and electronic equipment. Do you want to find out which substances? 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.