The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
Here’s a hint: Compliance with new regulation in Europe is a high priority.
How in touch are you with current MDR guidelines?
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.
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 it comes to compliance, the FDA does not grant special dispensation.
The new MDR introduces several changes that manufacturers must consider right away.
Define, document and implement!