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European IVDR Consulting in Support of IVDD to IVDR (2017/746) Transition

The EU In Vitro Diagnostic Regulation (IVDR) is the most substantial change to regulatory oversight of IVDs in decades. Today only 10-20% of IVDs are subject to Notified Body scrutiny and CE Marking certification in order to be legally marketed in Europe. Starting in 2022, that will jump to 80-90%. Does your Technical Documentation stand up to the strict new regulatory paradigm? Do you have a transition plan underway? The Oriel STAT A MATRIX team can help you prepare and/or get trained on the IVDR changes

Preparing an IVDD to IVDR gap assessment

  • You can’t create an IVDD to IVDR transition plan unless you understand where you are now. Frankly, it can be overwhelming to figure out where to begin. Here’s what we can do to get you started on the right path:
  • Classify your IVDs under Annex VIII of the IVDR
  • Conduct a review of your existing technical data and detail the gaps
  • Review your existing claims and intended uses
  • Examine your postmarket surveillance and risk procedures
  • Recommend updates to your Economic Operator agreements
  • Identify all specific gaps in your compliance with the IVDR and provide guidance on how to fix them

Crafting an EU IVDR transition plan for your product portfolio

With a thorough gap analysis completed, we can help craft your transition plan. If you have List A, List B, or self-test devices currently subject to Notified Body intervention and CE certification, we will examine all expiration dates for those certificates and make recommendations on whether we think you should strategically go for IVDR certification now or renew your existing IVDD certification before the expiration. After conducting your gap assessment, our team will also be able to provide estimates of how much time (and money) you can expect to spend on getting specific products to be IVDR-compliant. At that point, you may even decide to pull some marginal products from the market after their existing certificates expire or May 2022, whichever comes first. If your devices are not currently subject to IVDD compliance, we will help craft a plan to get all of them compliant before the IVDR enforcement date.

Getting your IVD Technical Documentation in shape

Many IVD manufacturers may not be able to produce the clinical data required by the IVDR, specifically the Performance Evaluation Report (PER). The PER includes data related to scientific validity as well as analytical and clinical performance, and the requirements are different from those mandated in the US. We will examine all of your existing data (including postmarket data) and make specific recommendations on gaps that need to be closed. We can be as involved in that process as you like, supplementing your internal efforts or taking a lead role on specific compliance projects. If you want us to participate in discussions with reference labs and testing houses, we can assist with that as well.

Additional ways we can help you prepare for 2017/746

Our consultants have deep expertise in European IVD compliance and significant prior experience working in RA/QA roles for IVD manufacturers. We can provide support via:

Let our IVDR consultants get your product portfolio ready for IVDR compliance. Contact us today to learn more or request a proposal. 

Select a course below to learn more or to register.
 
Course Name Public On-site
New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)

Learn key changes between IVDD and IVDR, discusses how to make the transition, learn best practices for transitioning. Click to learn more.

Provided below are a variety of practice related white papers, market updates and case studies.

EU IVDR Regulation + Table of Contents

EU MDR Regulation + Table of Contents

Overview of the European IVDR (2017/746)

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