In order to face the lack of reliable Covid-19 test devices, the European Commission published the required performance criteria. Read here all the details!
Medical devices and healthcare auto
MDCG issued Guidance on clinical data of legacy devices (01/03)
The MDCG has issued a Guide for manufacturers and Notified Bodies on Clinical Evidence. Learn all the clarifications on legacy devices in this article.
Guidance on Regulatory Requirements for Ventilators and Related Accessories
The Medical Device Coordination Group issued a guidance on how to place ventilators on the EU market during the Covid-19 pandemic. Find out all the details.
Coronavirus: special measures and ban on rapid self-tests in Belgium
Obelis can still assist you in quickly submitting all the other IVDs that are critical for addressing the COVID-19 outbreak!
MDR Delay: which provisions have been changed?
1-year delay will provide you with additional 12 months to finalize your compliance with the MDR, which is a complex and lengthy process!
New 2020 lists of harmonised standards for medical devices made available
These harmonized standards are drafted to presume compliance with the essential requirements they cover in support of the following legal acts.
MedTech Europe and European Commission approach on EU ArtificiaI Intelligence and Data strategy
Medical device manufacturers are using these technologies to innovate their products to better assist healthcare providers and improve patient care.
Do you want to place your 3D printed product on the EU internal market to be used in a medical context and fight against COVID-19?
Is there any applicable EU legal framework in the case of 3D printing?
COVID-19: Free European standards and easier MD & IVD registration
Europe adopts new measures to respond to COVID-19 outbreak, including measures to speed up MD & IVD device EU market introduction and free info on EU standards.
Withdrawal of notified body services: MHRA takes over
Updates from the Medicines and Healthcare Products Regulatory Agency on the withdrawal of several UK-based notified bodies.