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EU IVDD vs IVDR Gap Analysis for IVD Manufacturers

The EU In Vitro Diagnostic Regulation 2017/746 (EU IVDR) replaces the In Vitro Diagnostics Directive (IVDD) and will be applicable to most IVDs sold in Europe. Regardless of whether you have been selling regulated IVDs in Europe for decades or your diagnostic devices are newly regulated by the IVDR, you need to understand the gaps in your compliance and how to fill them. We can help.



Let Our Team Answer These Key Questions for You…

  • What is the classification of our IVD under the IVDR?
  • When do we need to comply with the EU IVDR?
  • How close are we to being IVDR compliant currently?
  • How long will it take us to gather clinical data needed for IVDR?

Assessing Your IVDD to IVDR Transition State of Readiness

Under the IVDD, only 15% of IVDs (mostly high risk) required review and approval by a European Notified Body (NB). Now, with the IVDR, roughly 85% of IVDs will require review to obtain CE Marking certification in Europe. As the IVDR compliance dates get closer, competition for limited Notified Body attention will be fierce. Demand for fewer NBs, combined with time-consuming new clinical and risk management requirements, means you need to start early to get on the list with a Notified Body and ensure that your IVDs remain on the European market. Understanding where you are falling short on IVDR compliance is a logical first step. Read more about IVDR deadlines below and in-depth here. We recommend starting your IVDD to IVDR transition journey at least 18-24 months before these deadlines.

* Class A (nonsterile) IVDs are NOT included in the extension and must comply now. Although Notified Body intervention is not required, compliance with certain provisions of the IVDR (PMS, importer, EUDAMED registration, etc.,) is required.

** These extended deadlines apply only to products in compliance with the In Vitro Diagnostic Directive (IVDD) prior to May 27, 2022. If the device has existing IVDD CE certification, significant changes to the product or its intended use may trigger IVDR certification.

We Evaluate All of These Areas as Part of Our IVDR Gap Assessment

  • Regulatory strategy to provide an efficient grouping of IVD products into families
  • Classification of your device(s) under Annex VIII of the IVDR
  • Compliance with IVDR General Safety and Performance (GSPR) requirements
  • Current technical documentation, including links to design and development files
  • Performance evaluation procedures, processes, and deliverables, including the Analytical Performance Report, Scientific Validity Report, and Clinical Performance Reports
  • EN ISO 14971:2018+A11:2021 risk management compliance, including benefit-risk assessment
  • Unique Device Identification (UDI) and traceability requirements compliance
  • Postmarket surveillance planning, data collection, and reporting
  • Overlap between ISO 13485 quality management system and the IVDR

At the conclusion of our initial IVDD-to-IVDR gap analysis, we will identify areas in need of attention and organize specific workstreams that lay out a clear path to compliance. While we do not conduct a full audit of your QMS as part of this IVDR assessment, we can certainly do so!

We’re Ready to Help Your Transition

Many IVD manufacturers will vastly underestimate the time needed to get into full compliance with the IVDR. Don’t be among them. Gain a competitive advantage and contact us today about conducting an IVDD-to-IVDR gap analysis that will put you on the path to compliance with the European In Vitro Diagnostic Regulation.

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

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