The EU MDR one-year delay gives you the opportunity to take a more measured, strategic approach to compliance. However, it’s important to use the time wisely. In this blog, we highlight five steps that will help you on the road to UDI compliance. We’ll also talk about how to review your existing labeling processes and ensure you’re using the best system and approach for your business, both now and in the future.
THE FIRST THREE STEPS
Step 1: Set up the process.
Step 2: Develop an internal process for UDI and EUDAMED registration requirements.
Step 3: Submit your UDI data to EUDAMED.
Remember to look beyond the regulation itself and uncover the hidden costs and problems you might have in your existing workflow. Keep in mind that compliance exercises are about more than buying a tool or a system; they’re about process improvement. And any process improvement exercise starts with people – identifying the stakeholders involved in the process and getting them all on the same page. The importance of this step cannot be underestimated. One of the primary reasons compliance projects go wrong is because the project managers failed to identify a stakeholder critical to the process. As you work with your stakeholders, it’s important to clearly assign roles and responsibilities for each stage of the process. Try to answer the following questions:
- What role will IT play in the process?
- When will the quality and regulatory teams get involved?
- Who will be responsible for data updates and maintenance?
- What about security?
- What role will third parties play in the process?
And remember, instead of using existing processes and tweaking them to fit the EU MDR, find ways to improve them and then implement technology on top of that optimized process.
Step 4: Update your labels.
The ‘updating your labels’ step includes creating the new designs and verifying them. Redesigning your labels to satisfy EU MDR will be quite a task. When considering which type of labeling system would best suit your needs, try to address the following questions:
- How much time will IT staff spend updating label templates?
- Can I make it easier and less time-consuming for them by switching from hard-coded label templates to dynamic templates?
- Can I give staff access to a more intuitive label design software that will make it easier for them to update and maintain label templates?
- Can I automate mass label changes and approvals?
- As businesses are shifting to a more remote work environment, can I make labeling accessible to off-site staff?
It’s also important to consider quality when updating your labels. Rather than taking a manual approach to quality control, digitize quality assurance by incorporating review and approval workflows into your label management system. This will give you improved accuracy, transparency and efficiency. You also need to lock down UDI information to reduce the likelihood of errors or unapproved changes. Also, think about how you will handle and approve mass label changes.
Finally, you will need to integrate labeling with device identifier (DI) and production identifier (PI) data.
Regardless of where the data is stored, integrating these systems with labeling will provide you with a single source of truth for your label data. If your company has a Cloud-first strategy, or your business systems are Cloud-based, make sure you select a label management system that offers a Cloud option and supports Cloud-to-Cloud integration.
Step 5: Go into production
One of the critical tasks before going live is completing system validation. Whether you use an off-the-shelf solution or you’ve configured your labeling solution to your environment, you will need to validate it. Here it can help to have a validation-ready labeling solution that is built for life sciences companies and streamlines the validation process.
Once you’ve created an MDR-compliant labeling process, you want to ensure your labels stay compliant, no matter who prints them. Consider granting your suppliers and contract manufacturers remote access to your labeling using Cloud technology. In this way, you can guarantee that your labels are accurate and compliant, because they are printed based on templates and data housed in your own systems.
EU MDR: the opportunity
To recap, as with any regulation and the accompanying compliance exercise, MDR represents both opportunities and risks. MDMs everywhere are fully aware of the risks of non-compliance, yet not to be overlooked are the risks associated with a stopgap approach to compliance. To mitigate these risks, it’s important to look at how you implement your MDR-compliant labeling processes, so that you end up with an efficient, streamlined approach to labeling.