Medical Devices and Healthcare Auto Archives

Spanish Authority Issues New Guidelines for Personal Care

The Spanish competent authority has updated its instructions for requesting authorisation for commercialising personal care products. Visit our page for more details!

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!

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.

A professional uses an ultrasound machine

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.