The MDCG has issued a Guide for manufacturers and Notified Bodies on Clinical Evidence. Learn all the clarifications on legacy devices in this article.
Medical devices and healthcare auto
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.
Covid-19 Q&A Guidance Document released by the EU Commission
The European Commission published on April 3rd a Q&A document on medical, implantable active and in vitro diagnostic medical devices to address the emergency situation the medical devices industry is undergoing on a global scale.
Coronavirus (COVID-19): a focus on Class I Medical Devices Compliance
In the last months, many Class I medical Devices, like Facial Masks, rapidly became the most researched items on the EU and Worldwide markets.
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.