An Easier Approach to IVDR Technical Documentation

Although the Regulation (EU) 2017/746 in In Vitro Diagnostic Medical Devices (IVDR) presents several challenges for manufacturers, the technical documentation requirements can seem daunting. These requirements, however, are foundational for nearly every aspect of the regulation.

Whether you are new to the EU market or preparing an existing device portfolio for the IVDR, think of technical documentation as a series of pre- and post-market needs. This approach breaks implementation into more manageable pieces, making the process feel less overwhelming.

By understanding the landscape and regulatory requirements which apply to your products, compliance with the new regulation becomes more methodical. Annexes II and III of the IVDR clearly provide the general requirements; however, you will need to reference additional annexes to ensure you have the details you need (e.g., Annex I for GSPRs, Annex VI for UDI, Annex XIII for performance evaluation).

You know better than anyone what and how you are manufacturing. This knowledge will help you identify which legacy products to bring forward under the IVDR. To define the product portfolio, you must also classify which devices should be placed on the market as IVD devices. The classification influences the content included in the technical file (refer to MDCG 2020-16 and 2019-11). With products identified, you can turn to the regulation to understand what the IVDR expects based on your products.

Even with a device already on the market, most devices must be placed on the market again as IVDR-compliant. It is essential to consider pre-market technical documentation requirements and expectations to ensure you address all necessary regulatory requirements. This section focuses on documentation demonstrating how the IVD device's design and manufacture support its intended use and clinical benefit.

• Conduct a gap analysis to determine which requirements apply and what needs to be done. Annex II serves as a table of contents to help you find the technical documentation requirements and easily identify what applies to the lifecycle of your device. Remember, you always need a documented justification when certain Annex I general safety and performance requirements do not apply.
• Develop a plan for reaching compliance. Following your gap analysis of the current status of the pre-market documents, you should better understand what is expected and what you still need to address. As you develop your implementation plan, there are several things you need to consider:
  • Does your current quality management system (QMS) cover the extended IVDR requirements?
  • Which guidance documents and industry standards may be applicable to demonstrate compliance?
  • How do you identify and prioritize workstreams (e.g., labeling, performance evaluation, post-market surveillance)?
  • What internal resources are available to support IVDR implementation?
• Close the gaps. Now you are ready to make strategic considerations, such as starting early with those changes that may affect production (e.g., postpone UDI carrier on device labeling, rolling out changes in the instruction for use (IFU), start implementing UDI allocation and tracking system early on). Identify dependencies and determine options for parallel workstreams. Most importantly, do not underestimate the work needed to meet these requirements. Plan smart and act effectively by:
  • Identifying specifications to be adjusted.
    • Matching the new industry standards
    • Matching the requirements from the IVDR
  • Identifying external testing or services. As the timeline for external tests will depend largely on the availability of your testing partner, prioritizing these needs early can help prevent delays.
  • Ensuring your risk management processes are comprehensive. Risk management is central to your documentation. Start to build evidence in terms of your documentation according to your processes and the nature of your device. The risk management plan itself will help you execute risk management activities for verifying risk control measures. At the end of an assessment, the benefit-risk ratio then provides a clear picture regarding the safety and effectiveness of a device.

Annex II guides you through the process and can help you navigate through your technical documentation:

As well as having your pre-market documents in order, you must document whether your surveillance mechanisms meet IVDR requirements and whether your plan is relevant to the device’s risk. Equally as important is the clarity of your post-market surveillance (PMS) plan. This document must be suitable for an external audience and clearly organized to prevent ambiguity.

• Plan your surveillance. Before planning surveillance, you must have a surveillance process built into your QMS (Article 10(8i)). From there, you can develop your PMS plan based on aspects such as your device class (A, B, C, D), risk assessment outputs, and the novelty and complexity of the device itself.
  • Class A or B: You will need to prepare a PMS report and keep it updated according to your PMS plan or as needed to reflect changes.
  • Class C or D: These devices carry higher risk, so a periodic safety update report (PSUR) is required annually but can be done more regularly.

Although device class dictates certain reporting elements of your PMS, your efforts must balance reactivity with proactivity, which distinguishes IVDR from many other regulations.

• Continuously evaluate your performance. The PMS plan addresses the creation of a post-market performance follow-up (PMPF) plan. This serves as a continuous process that guides the regular updating of your performance evaluation.

Remember to produce your technical documentation in a clear, organized, readily searchable and unambiguous manner and address all the elements listed in Annexes II and III. These steps should clarify what is needed in your technical documentation to place IVD devices on the market under the IVDR.

NSF helps you navigate the process, from training and preparation of your technical files to consulting, technical file remediation, performance evaluation reports, and more.

Source

¹www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-ivd-mdma-toc-n13.pdf