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Medical devices and healthcare auto
HPRA Warns of Dangerous Melanotan 2 in Tanning Products
On June 27, 2022, the Health Products Regulatory Authority (HPRA) published an alert about the serious health risks linked to the substance Melanotan 2. Read all the details!
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!
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.
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.