Roadmap for Successful IVDR Transition, Part II: Technical Documentation & Software

February 17, 2022

The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching (May 2022). In this blog series, we discuss the final months before the IVDR date of application along with how to identify and plan for a transition from IVDD to IVDR and ways organizations can successfully manage the transition.

What is IVDR? It's the new regulation for in vitro diagnostic medical devices distributed in the European market. The current certifications are related to the In Vitro Diagnostics Directive (IVDD) only. Both IVDD and IVDR focus on quality and safety but the IVDR will significantly increase the transparency throughout the product lifecycle. IVDR will also focus more on the supplier management, as well as the quality management system in general.

Technical Documentation Requirements

Understanding your classification is important in terms of the regulatory burden that you're going to face in this transition to being compliant with IVDR. The conformity assessment by a notified body is required for class B, C, and D devices before placing a device into the market. Companies are no longer allowed to self-certify these types of products. So, in order to meet the regulation requirements, all the technical documentation must be in place. Also, if you haven't renewed the certificate within the past year, you're going to have a significant amount of work to do to prepare the submission to the notified body for all but class A devices (general lab use devices and some instruments).

To put the technical documentation together, the first question a manufacturer should ask is, what's the intended use of the product? This is a requirement for the compliance with IVDR. Changes to the intended use can have an impact on other files with other regulatory agencies, for example your registrations with the FDA, with Australia and with the Chinese regulatory bodies. So, although you are often adding more detail to be compliant with IVDR, you may have to manage how this additional detail could affect your registration with other regulatory agencies and how these other regulatory agencies want to address the interconnectivity or the impact they may have in their country.

Software Analysis

Under the new IVDR regulation, there's an emphasis on software and its impact to classification. Types of questions that you will need to ask yourself are: Does the software just run the instrument? Is the software an algorithm that will interpret the results from an assay or provides a medical decision? The answers impact the classification of your device and the technical documentation you need to provide. This also increases the burden on manufacturers providing a post market surveillance plan. Previously, this wasn't a significant or substantive component of technical documentation, although manufacturers within their quality systems regulations had these outlined. There is a new emphasis on these post market surveillance plans that need to be included with technical documentation, as well as periodic safety update reports. If your device evolves over time, notified bodies will expect updated documents that reflect those changes.

Other types of questions that will need to be answered are: Does the software run the overall functioning of the instrument? Does the software simply load or move samples within the instrument? Does the software operate independent of the device? How is the software involved in interpreting the result? Is it interpreting a measurement and providing a result or giving a clinical output? These are all important characteristics to understand how the software is operating because they will impact the classification, and therefore the documentation you must provide in your submission.

The next point of consideration is the performance evaluation plan. The performance evaluation plan is composed of both your analytical studies and your clinical studies. This is tied to the specifications and the requirements of the device. You would need to know for example, how was the assay cut off determined at 0.7 and what does that mean? Who was it determined that the assay needed to have a certain cutoff? This and many other questions need to be asked and answered as you evaluate the specifications and requirements of the device. Finally, is the post market surveillance plan robust? Does it cover all the appropriate facets (software, instrumentation, and complaints) of the device? Are the complaints that may affect the performance of the device taken into consideration? How are you planning to compile the complaints, reports or changes that have occurred in terms of possible suppliers or third-party manufacturers that you are using? These should all be part of the post market plan for it to be adequate to comply with the new IVD regulations.

The performance evaluation plan includes the items that the notified body will want to see when going into documentation review. Is the clinical performance study plan up to date? Does it have rationale for how the clinical performance of the device was validated? The performance evaluation plan should include the analytical study reports, the clinical study reports, and the numerous post market reports that must be considered in your quality management system. These should be supportive and alleviate any concerns that a notified body may have when reviewing the technical documentation.

Pitfalls and Considerations

Here is an overview of key considerations:

  • You must determine how software affects your classification of your instruments. If you have a plate that has software that is only moving a plate from one place to another, or that's allowing the instrument to aliquot certain volumes of your reagent into wells, you likely have a class A device. For these products, manufacturers don't need to make a submission to a notified body to put the device on the market, because they are not required to submit technical documentation. Moving from a class A to a class B or higher risk device will lead to more regulatory burden. That is, change request assessments by a notified body will be required when you make a change to an instrument or a platform. This change notification can greatly complicate and slow the speed of change, especially when third party manufacturers are involved. The time to introduce the change is not only based on the notified body review, but also agreeing on the timeline for implementation with the third party.
  • Once you are clear on the classification, you have to generate the documentation and ensure that the quality management system is adequate to comply with the regulations. The compliance of your quality systems to the regulations will be the central focus of any audit.

Remember, the new IVDR will come into effect in May 2022 which will impact all IVD companies. With our blog series leading up to the deadline, ProPharma Group experts will guide you in transitioning to the new regulations. In the next part of this IVDR series, we will discuss project management. This includes not only the management of the team supporting the transition, but also changing the mindset of your organization to understand the new paradigm of IVDR and structuring the transition in a way that the required changes to comply with the regulations are sustained after the project team is disbanded.

ProPharma helps 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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