To prevent market disruptions and give manufacturers enough time to certify their medical devices under…
News
Covid tests under IVDR – How to sell them on the EU market?
The new EU Regulation on in vitro diagnostic devices (IVDR), applicable since May 26, 2022, affected the classification and compliance process of COVID-19 tests.
Endocrine Disruptors — The revision of the CLP Regulation
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.
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!