FDA’s Voluntary Malfunction Summary Reporting Program to Reduce Number of MDRs
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
Tag Archives: MDR
New MDR: One Year into the Transition Period
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
Five Most Popular Articles of 2018 (So Far)
Here’s a hint: Compliance with new regulation in Europe is a high priority.
Understanding FDA’s Guidance on Medical Device Reporting
How in touch are you with current MDR guidelines?
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.
3-D 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.
No MDR Procedure: There is No Time Like the Present!
When it comes to compliance, the FDA does not grant special dispensation.
A Smooth Route to the New Medical Device Regulation
The new MDR introduces several changes that manufacturers must consider right away.
MDRs: Establish a Procedure
Define, document and implement!
