An interview with Sarah You about her experience in following one of our expert’s professional trainings on EU Regulations and the insights she gained from it.
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Upcoming restrictions for single-use plastic packaging (PFAS) in Belgium
In November 2022, the Belgian government notified the EU of a draft Royal Decree to limit the placing on the market of single-use plastic products. Read all the details in our article!
What manufacturers need to know about the new extensions for legacy devices
There was a general agreement between the Council of the EU representing the EU Member States and the European Commission to extend the transitional period (legacy period) to the Medical Devices Regulation (MDR). Read all the details in our article!
Webinar: EUDAMED Actor & Device registration
Register and learn all the details about EUDAMED, the European database for medical devices and In-vitro diagnostics!!
Seminar: Placing Medical Devices and In-Vitro Diagnostic Devices on the Union Market (EU) – News and Challenges
Register for our new live webinar about MDR and IVDR! On December 19, at 3:00 pm (Beijing Time), in collaboration with TÜV SÜD and AKRA TEAM GmbH!
New Proposal from the EU Commission for a Cyber Resilience Act
European Commission presented a proposal for a Regulation on cybersecurity requirements for products. Read more!
What are the effects of the implementation of MDR on the EU medical device market?
Discover the effects of the implementation of MDR on the EU medical device market and the most relevant challenges in our new article!
MDR: Notice to Manufacturers for Implementation
Medical devices that have obtained CE Certificate under the MDD 93/42/EEC can circulate in the EU market. Learn the conditions here!
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!
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!