IVDR signals In Vitro Industry Shake-up
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
Tag Archives: European Union
The New MDR: Opportunity Knocks
A look at the practical implications of the regulations, the market opportunity and tips for compliance.
New EU MDR Regulations and Revamp of the Medical Device Directive
An overview of the key impact points and challenges of European Union Medical Device Regulation.
Why the EU Considers Prescription Support Software a Medical Device
SNITEM & Philips France vs. Health Minister: the ECJ defines the conditions under which software for assistance to the medical prescription can be qualified medical device within the meaning of the Directive.
Three-dimensional (3D) printing: forgotten by the new EU Medical Device Regulation?
The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.
When Health-Related Apps Qualify as Medical Devices in the European Union
According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.
A Smooth Route to the New Medical Device Regulation
The new MDR introduces several changes that manufacturers must consider right away.
How to CE Mark a Medical Device that Incorporates a Drug
An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.
