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.
News
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…
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.
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!