IVDR Gap Analysis for a US Manufacturer Preparing Its Transition to the European Market

Context

A US manufacturer of in vitro diagnostics had been marketing its products in the European Union for several years. With the entry into application of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), its products — previously exempt from notified body involvement under the former Directive 98/79/EC — became subject to significant new requirements.

The challenge

The manufacturer had already begun its IVDR transition and wanted to ensure it was on the right track, before submitting its file to a notified body and committing further resources. The risks of a poorly prepared transition were real: delays, unexpected costs, blocked sales on the European market.

The One Health Compliance solution

• Conduct of a gap analysis using best audit practices to assess the level of regulatory compliance and propose a prioritised remediation plan.
• The analysis integrated the specificities of the US approach (FDA) compared to the European approach, the eligibility criteria for the IVDR transitional period, and the balance between European market share and the budgetary implications of achieving compliance.

The result

• A comparative table of available options usable as a decision-support tool.
• A strategic remediation plan presented during dedicated debrief sessions.
• A report ready to present to the notified body which provided a positive response upon receipt.

✓ Positive response from the notified body ✓ Actionable remediation plan ✓ Informed decision on available options

Does your situation share similarities with this case? Feel free to get in touch to discuss it.

Sandra Dejean, PharmD – Founder of One Health Compliance

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