As an IVD (In Vitro Diagnostic) Korean manufacturer, accessing the EU (European Union) market can…
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How to select a Notified body for your in vitro diagnostic medical devices?
Most in vitro diagnostic medical devices require the involvement of a notified body or approved…
New restrictions for Butylated Hydroxytoluene (BHT) and Acid Yellow 3 apply as of July 2023
Introducing new restrictions for Butylated Hydroxytoluene (BHT) and Acid Yellow 3 in cosmetic products, the Commission Regulation (EU) 2022/2195 brings changes to the industry
MoCRA deadlines you need to keep in mind when selling cosmetic products in the U.S.
MoCRA deadlines you need to keep in mind when selling cosmetic products in the U.S
Obelis Wins a Second Trends Gazelle Award: Growing from Medium-Sized to Big Enterprises Category
Obelis Wins a Second Trends Gazelle Award.Growing from Medium-Sized to Big Enterprises CategoryWant to know more? Visit our page!
Obelis Group to support small medical device companies in Luxemburg’s Fit 4 Innovation Programme as Regulatory Consultant
We are thrilled to announce that Obelis Group has been chosen as one of the regulatory consultants for the Luxemburgish Ministry of Economy’s Fit 4 Innovation
New legacy period for medical devices is official: automatic extensions and derogation for expired certificates
To prevent market disruptions and give manufacturers enough time to certify their medical devices under…
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!
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!