The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching in May 2022. In this blog series, we discuss the final months before the IVDR date of application, how to identify and plan for a transition from IVDD to IVDR, and ways organizations can successfully manage the transition. In our previous series posts, we have focused on the key regulatory elements you should understand. Our last post of the series closes out with some project management and organization change management items that are related to an IVDR implementation.
What does it mean to have strong project management for a successful implementation? Clear understanding of the objectives, scope, deliverables, timelines, ownership, and “definition of done.” Given the 150+ pages of IVDR regulation, those elements along with identification of the integration points will facilitate implementation of IVDR activities as there are impacts, responsibilities, and required collaboration across multiple functions.
Can you pursue remediation to IVDR without a strong project management structure? Sure. But, you will risk not being compliant to a critical piece of regulation, lacking transparency on project progress towards IVDR compliance, missing critical IVDR timelines, potential duplication of efforts across multiple stakeholders, and missing critical issues that could have been identified as a result of assessing compliance to the regulation. Hence, having some form of project management structure is important for implementation of IVDR requirements and successfully maintaining your presence in the EU market.
IVDR Checklist and Deadlines
Our experts have put together a short IVDR checklist to help you assess your implementation of the IVDR regulation using core, basic questions as the barometer of your progress. As mentioned in Part II of this blog series, it is important that you have the intended purpose and classification of your product defined first as well as sign-off from your core team and senior leadership sponsors on those items.
Why is that important? Because this provides the foundation for how you complete your IVDR implementation. For example, if you have a class B versus a Class D product, the volume of tasks that will need to be completed are much greater for one class versus the other – resulting in more deliverables, greater stakeholder involvement, and greater accountability.
As of the writing of this piece, there are four notified bodies certified for IVDR: BSI, DEKRA, TÜV SÜD, and TÜV Rheinland. It is important to understand your notified bodies’ plans to become certified for IVDR, associated timelines, and your contingency plan should they not get certified for IVDR. If you do not have a notified body, you will need to determine the best one for your organizational, regulatory, and geographic needs.
One often missed preparation for the IVDR certification is a mock inspection. This will allow you to assess regulatory readiness via documentation, processes, technology, and governance. This will also challenge you to understand whether your processes are truly fit for purpose and meet the spirit of the regulation. Finally, your process leads can assess their ability to effectively speak to the new regulation or processes they oversee.
A Case Study
An In Vitro Diagnostics client had executive and senior leadership support within their PMO and functions but did not have enough subject matter experts to deliver the program due to the many daily work priorities competing with IVDR readiness. The IVDR program also struggled with retaining their external skilled experts, putting in jeopardy their ability to meet the May 2022 deadline.
We quickly enhanced their program governance structure, identified and staffed experts to close out the skill gaps, confirmed understanding of devices classifications, project management deliverables (e.g., charter, project plan), and definition of done. We updated or newly developed required IVDR documentation and confirmed process owners. We helped them ensure that project resource attrition was minimized, deliverables were appropriate to the scope of the device’s portfolio, and content will be ready and available to share with notified bodies for the certification process per the deadlines.
Sustainability
Once you have achieved certification with IVDR, you must now sustain the process. Sustainability means proactively ensuring that your processes are fully optimized and in alignment with any newly produced amendments and guidances, have ongoing monitoring and continuous improvement of the processes, and deliver ongoing training/communications to support the evolving needs. This is critical to ensure that you are fully aligned with current IVDR expectations and your devices meet the current standards.
As a reminder, the new IVDR will come into effect in May 2022 impacting all IVD companies. With our blog series leading up to the deadline, ProPharma Group experts will guide you in transitioning to the new regulations. This concludes our blog series on IVDR considerations, pre-IVDR deadline.
We help clients ensure that they are compliant with the current directive as well as transitioning through MDR/IVDR so that they can continue to market compliant products in the European Union. Contact us for support.
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