Usability engineering (UE) support for the EU transition to IVDR

ANSWERED ON THIS PAGE:

  • Why should your company want to get an early start on IVDR transition?
  • What are some of the major UE differences between IVDD and IVDR?
  • What services does Emergo by UL provide to IVD manufacturers preparing to transition to IVDR?

The European Regulation 2017/746 on in vitro diagnostic medical devices (commonly known as IVDR) repeals the In Vitro Diagnostic Directive 98/79/EC (IVDD). There is now less than two years left of the transition phase from IVDD to IVDR, and the requirements for usability are much more pronounced in IVDR when compared to IVDD. Many IVD manufacturers have yet to appreciate the consequences of these changes and adequately prepare for Notified Body scrutiny of the Technical Documentation, including usability engineering (UE) data.

Why do you need to get started now with IVDR compliance preparation?

A number of key features of IVDR may cause delays:

  • Effective up-classification of many IVD types. The new risk-based classification system employed under IVDR will cause many devices that formerly called for self-certification to require Notified Body intervention. This up-classification of sorts will take place on a much greater scale than anything experienced with implementation of the parallel Medical Devices Regulation 2017/745 (MDR). For example, in 2018, a report commissioned by The Dutch Health and Youth Care Inspectorate estimated that the percentage of IVDs requiring Notified Body involvement would increase from 7% to 84% under the transition to the IVDR.
  • Limited Notified Body capacity. European Notified Bodies will likely still be working through the transition to MDR when IVDR goes into effect, reducing their availability. Additionally, very few Notified Bodies have been designated under IVDR (as opposed to MDR). It is unclear how many IVDD-designated NBs plan to pursue IVDR designation, but it is likely to be far fewer than under the MDR.
  • More stringent clinical performance data and usability engineering (UE) requirements. The switch to a lifecycle approach to certification translates into a greater emphasis on post-market surveillance (PMS) and post-market performance follow-up (PMPF) reports. Manufacturers will need to provide more data to demonstrate that a device performs safely and effectively, and IVD companies may need help with their UE (equivalent to human factors engineering) practices.
  • Increased Notified Body scrutiny of IVD Technical Documentation. As the vast majority of IVDs under the IVDD are self-certified, many device manufacturers have not been subject to Notified Body audits previously and are ill-prepared for the scrutiny with which their Quality Management System (QMS) and Technical Documentation will be reviewed, including elements such as their risk management documentation which is intrinsically linked with UE considerations.

What are the major differences between IVDD and IVDR from a UE perspective?

The new Regulation contains a range of General Safety and Performance Requirements (GSPRs). As with MDR, usability features strongly in the GSPRs, and therefore manufacturers will be required to compile a usability engineering file to document the evidence that their IVDR meets these GSPRs.

Some of the key usability requirements embedded in IVDR include:

  • Defining the intended use, intended users, and expected use environments
  • Design for safe use by the intended users in mind
  • Design for lay users where appropriate (e.g., self-testing devices)
  • Focus on identifying potential use errors and eliminating where possible

Performance evaluation reports and the post-market performance follow-up (PMPF) are also introduced as new features of IVD regulation, and both will include a heavy emphasis on UE in order to demonstrate the safety and performance of their devices. Manufacturers are challenged to design IVDs that will not only satisfy regulatory requirements but will also perform effectively under continued scrutiny. This requires utilizing engineering best practices to boost safety and usability, as well as properly documenting the design process, including usability testing with intended users.

How can Emergo by UL help IVD companies to prepare for IVDR implementation?

Emergo by UL brings to bear the coordinated knowledge of a wide range of experts, from our team of European market access consultants with specializations in MDR and IVDR, to our industry-leading Human Factors Research & Design division. We can help your company to plan and document all stages of your UE process, ensuring that your product is safe, effective, and tailored to the needs of users. Emergo by UL also offers IVDR gap analysis and transition support, along with corporate training exercises to help your team understand and prepare for the new IVDR requirements. We maintain an online IVDR Resource Center so you can keep track of updates and offerings, and our RAMS digital RA/QA platform makes it easy to track your product registration and research access to new markets. Smart companies won’t wait to start thinking about IVDR readiness; we can make your preparations easier and more impactful.

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