Medical devices and healthcare auto Archives

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.

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.

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!