On 23 May 2023 the Official Journal of the EU published a new law, the General Product Safety Regulation (GPSR). From 13 December 2024, manufacturers will have to comply with the new GPSR.
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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!
Webinar: Steps to enter the Australian market for Medical Devices
Manufacturers! Interested in the European Commission proposal for legacy devices? Our consultant will be offering an interpretation of the European Commission proposal for legacy devices regarding the following date: March 20, 2023
What is CE Marking?
A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
Selling medical devices online in the EU
Complying with the rules on distance selling of medical devices and in vitro diagnostics device is a fundamental step when a manufacturer chooses to sell the devices online.
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
The biggest amendment of the U.S. Cosmetics Law since 1938
The US government issued the Modernisation of Cosmetics Regulation Act (MoCRA) of 2022, which will apply as of December 29, 2023.
Seminar: Placing Medical Devices and In-Vitro Diagnostic Devices on the Union Market (EU) – News and Challenges
Medical Device and In-vitro Diagnostic Industry Discussion: Key Takeaways on IVDR and MDR Implementation Challenges
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…