3. Rome wasn’t built in a day – label management overhauls take time
The biggest impact MDR will arguably have on medical device manufacturers relates to the scale of work involved – but many companies will underestimate this and leave projects too late. Dispersed teams and disjointed processes, as well as inevitable duplication between content sources such as translation databases (for instance where these have existed separately for label and IFU creation), make for highly complex scenarios that take time to unravel. And this all needs to be done before improvements can be implemented to streamline and automate processes, such as change management.
If organizations leave MDR preparations until the eleventh hour they will be forced by time pressures to do the minimum required for compliance, even if that is a costly workaround that does not deliver the quality control, compliance confidence or process efficiencies the manufacturer needs – fail to prepare, and prepare to fail!
4. Regulatory changes won’t stop at EU MDR
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Regulatory disruptions are not a one-off event. MDR will not be the only major global change to come the industry’s way, so companies that do not take the time to properly implement change are likely to have to do it all again the next time new requirements are introduced. For example, product serialization on device labeling is likely to become mandatory in the coming years.
For the time being, manufacturers marketing products in Europe only have to provide UDI information to the EUDAMED database but starting from May 2021 unique product identifier codes and detailed product serialization information will have to appear on all product labeling. The 2021 deadline applies for the most safety-sensitive – Class III – devices, followed by Class II in 2023, then Class I items in May 2025. The UDI must appear in plain text on all packaging parts of a product, be machine-readable, and include a wealth of very specific information under two different categories – a Device Identifier (DI) and a Production Identifier (PI). There is a lot to get right in the coming months and years.
Address new regulation now and realize benefits for years to come
The medical devices sector has not previously had to respond to new regulations to both labels and IFUs at the same time, and the new measures will highlight the flaws in existing disparate processes. Organizations need to begin to re-evaluate their manual processes now to ensure a consistent and automated approach before the regulation is implemented.