The Spanish competent authority has updated its instructions for requesting authorisation for commercialising personal care products. Visit our page for more details!
News
EU IVDR now applies in Europe:What should IVD manufacturers do to comply?
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!
Safety of toys: European Commission opens consultation on the use of titanium dioxide
In the European Union, it is essential that toys are safe for children and that all possible risks are minimized.
Compliance Success Stories: Meet Samsara Vision!
An interview with Samsara Vision about the different compliance steps and the process to launch their products in the market.
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!