August 2021

· 9 min read

An Easier Approach to IVDR Technical Documentation

Before placing in vitro diagnostic (IVD) devices on the market, most manufacturers will need their technical documentation assessed by a notified body.
Man working on the computer with some files around IVDR Technical Documentation Assessment | NSF International

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).

Define Your IVDR Portfolio

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.

Pre-Market Technical Documentation

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:

Section of Annex II
1
Description
Device description and specification, including variants and accessories
Recommendation
Photos of all components and formats are helpful additions.
Section of Annex II
1.2
Description
Reference to previous and similar generations of the device
Recommendation
This provides a history of your device lifecycle and helps the notified body understand how relevant evidence relates to the current device and claims.
Section of Annex II
2
Description
Information to be supplied by the manufacturer
Recommendation
Include all your labeling (including IFU) and any marketing material that makes claims. Claims need to be supported by evidence. See Article 7 of the IVDR.
Section of Annex II
3
Description
Design and manufacturing information
Recommendation
Implementing processes according to IVDR and EN ISO 13485
Section of Annex II
3.1
Description
Design information
Recommendation
Notified bodies need all details relevant for a basic understanding of design and manufacture. Risk management should be carried out according to EN ISO 14971.
Section of Annex II
3.2
Description
Manufacturing information
Recommendation
Don't forget to include full details of critical suppliers and subcontractors, as the notified body may decide to audit them, as well.
Section of Annex II
4
Description
General safety and performance requirements (GSPRs)
Recommendation
Demonstrating compliance is about more than presenting a report. You must show why the evidence is relevant for each GSPR. See Annex I of the IVDR.
Section of Annex II
5
Description
Benefit-risk analysis and risk management
Recommendation
These should be "living" documents, showing the efforts to continually understand and mitigate risks while ensuring the device remains in compliance.
Section of Annex II
6
Description
Product verification and validation
Recommendation
Implementing processes according to IVDR and EN ISO 13485
Section of Annex II
6.1
Description
Information on analytical performance of the device
Recommendation
Ensure you have performance study reports and evaluations in the technical file that clarify how the results of analytical studies support the intended use.
Section of Annex II
6.2
Description
Information on clinical performance and clinical evidence (performance evaluation report)
Recommendation
The performance evaluation report (PER) provides evidence on scientific validity, analytical performance and clinical performance to demonstrate a favorable risk-benefit of the device.
Section of Annex II
6.3
Description
Stability (excluding specimen stability)
Recommendation
Accelerated data is insufficient to support claims.
Section of Annex II
6.4
Description
Software verification and validation
Recommendation
Refer to the IMDRF TOC, 2020-1 and IEC 62304 for comprehensive information on what is expected to be submitted1.
Section of Annex II
6.5
Description
Additional information required in specific cases
Recommendation
Refer to the details in the Annex to see if this applies.
Section of Annex II
7
Description
Declaration of conformity
Recommendation
Ensure your declaration of conformity (DoC) fulfills the requirements of Article 17.

Post-Market Surveillance 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.

You Are on Your Way to Conformity Assessment

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.

We Can Help!

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

Ready to Begin the Process?

Contact us with questions or to receive a quote.

Source

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