Discover the new GDPR obligations for businesses and organizations within the EU and UK!
Medical devices and healthcare
Products falling under the General Product Safety Directive (GPSD): compliance process with the new Regulation from 2024
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.
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.
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.
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.
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!