All radio equipment, including its embedded software, must comply with the Radio Equipment Directive 2014/53/EU (RED). Find out all the details here!
Other Industries
In Vitro Diagnostic Devices: main steps to compliance and frequently asked questions
What is the path to EU compliance for IVDs? Find the answers to most common questions in this article and clear all your doubts!
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!
How is protective clothing regulated in the EU?
To find out more about how Obelis can help in making sure your protective products are compliant, talk to our team!
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.
Not all CBD extracts should automatically go through a novel food application
Cannabidiol (CBD) has been capturing more and more the attention of manufacturers and consumers in many different consumer products, particularly in food supplements in view of its multiple and alleged beneficial properties for human health. CBD is a non-psychoactive compound and one of the many cannabinoids contained in Cannabis.
EUDAMED POSTPONED, CONSEQUENCES FOR COMPLIANCE?
So which actions do Manufacturers have to take to be MDR COMPLIANT for the EU market?
Read more about it here.
EDPS Opinion on clinical research and data protection
Read more about the opinion of the European Data Protection Supervisor holds for the implications of GDPR on clinical research conducted within the EU.