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Consulting & Auditing

EU IVDR Consulting: IVDR Transition | Oriel STAT A MATRIX

The EU In Vitro Diagnostic Regulation (IVDR) is the most substantial change to regulatory oversight of IVDs in decades. The Oriel STAT A MATRIX team can help you prepare and/or get trained on the IVDR changes


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? Oriel STAT A MATRIX can help.

Need to get up to speed on the EU IVDR? Check out our class, Implementing the EU's new IVD Regulation.

How We Help

Conducting an IVDD-to-IVD Regulation 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 provide a detailed roadmap for transitioning to the updated regulation. As well, we can help you close the identified gaps one at a time, focusing on the areas that pose the greatest risk and impact on compliance. 

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. 

Training Courses

Classes are available as in-person or virtual instructor-led trainings. Select a course to learn more or to register.

Course Name Public Private
Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366
EU IVDR Training for Auditors
Performance Evaluation Report (PER) Training for EU IVDR Compliance
Medical Device Postmarket Surveillance (PMS) Program Implementation Training
Implementing the EU's New In Vitro Diagnostic Regulation Training Course (IVDR 2017/746)
Learn what it takes to meet usability requirements of IEC 62366, and understand how they relate to ISO 13485, ISO 14971, EU MDR/IVDR, and FDA.
For experienced auditors who need to perform internal and supplier audits to the EU IVDR requirements.

Learn what you need to put in your performance evaluation reports so that your in vitro diagnostic device can enter the EU market.

Understand how to implement a PMS process aligned with ISO/TR 20416:2020 that meets EU MDR, EU IVDR, and MDSAP requirements.


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

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

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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