Europe's Dedicated Healthcare UDI Conference
The Evolving EU Regulatory Landscape
"The times, they are a changin'" wrote Bob Dylan, and that is certainly true of healthcare regulations in Europe right now. With major changes to the regulatory system coming this year, it figures that there is a lot of confusion about what this means for various existing regulations and legislation, and none more so than UDIs.
The FDA deadline for Class II devices is fast approaching later this year, and while progress had been made last year by the IMDRF regarding EU-specific UDI regulations, the situation is still very much up in the air. Meanwhile countries like Turkey are mandating their own requirements, e.g. 2D barcodes.
So what can we do at this stage?
The 2016 European UDIs & Traceability for Medical Devices Forum will bring together regulatory experts from public and regulatory bodies, healthcare organisations and device manufacturers to discuss how best to prepare and react to the European regulatory changes with regards to UDIs.
The FDA UDI Regulations - Class II Deadline This Year!
Of course, for those companies that are FDA-registered, selling or operating in the US, irrespective of the EU regulatory situation you have a deadline fast approaching - the UDI deadline for Class II devices.
For small to mid-sized manufacturers, if you haven't already started your UDI implementation now is definitely the time - depending on your SKUs and number of sites, implementation of either printer/label tech on the lines or software infrastructure to handle the GUDID database submissions can take anywhere from 3-6 months.
For larger manufacturers with higher SKUs, you will no doubt be most or part of the way through your implementation by now, but this is no time to sit on your laurels - there are always ways to improve your project, and challenges during execution to overcome (or avoid altogether)!
And what about direct part marking, what's happening there?
What if you get audited by the FDA? There has already been at least one FDA 483 warning letter citing UDI non-compliance; what can you do to make sure you're protected?
Through regulatory discussions, panels, roundtables and practical case studies, this forum is tailored and uniquely positioned to highlight the state of urgency in the industry, address implementation challenges - plus maximise the ROI of your UDI implementation in the future, ensuring it continues to drive business value.