The assumption is understandable: data has been entered, the system has accepted it, something is…
Medical devices and healthcare auto
IVDR Readiness in 2026: Why Delayed Operational Setup Creates Major Risks
The window for watching and waiting on IVDR has firmly closed. For manufacturers of in…
How to Approach the Final Days Before the EUDAMED 2026 Deadline in May?
For manufacturers, authorised representatives, and distributors of medical devices and IVDs in the EU, the May deadline represents the moment when full EUDAMED requirements take effect across all relevant modules. With just 60 days remaining, the time for gradual preparation has effectively passed.
26 September 2024: last call for manufacturers of legacy devices
Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.
How to carry out clinical investigations of medical devices in the EU
To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.
Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations
Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations
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.
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!