Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
A look at the practical implications of the regulations, the market opportunity and tips for compliance.
An overview of the key impact points and challenges of European Union Medical Device Regulation.
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.
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.
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.
The new MDR introduces several changes that manufacturers must consider right away.
An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.