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!
Are you UDI-ready? Get the facts to achieve compliance fast.
The agency is focused on ensuring device establishments accelerate compliance with the eMDR process.
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.
If complex medical devices such as endoscopes and duodenoscopes cannot be reprocessed safely, why is this practice permitted?
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.