The EU proposal aims to introduce new hazard classes based on scientific criteria for endocrine disruptors as well as other chemicals which can accumulate in living organisms or enter the water cycle.
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Meet Obelis’ Customer Care Department
In addition to our Customer Success Department, Obelis has recently introduced a new client-focused Department: Customer Care. Read more here!
Obelis partner regulatory training: takeaways from Chemron FDA Korea
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.
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!!
What is new in the European Standardisation system?
To modernise the European Standardisation System, the European Commission proposed to amend the Standardisation Regulation as part of its European Standardisation Strategy of February 2, 2022. Read all the details in our article!
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!
Obelis group awarded as Great Place to Work 2022!
Investing in our employees is of paramount importance to us. We are more than honored to be awarded as Great Place to Work 2022!
European Authorised Representative (EAR) for manufacturers based in Turkey
There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!