Let Our IVDR Consultants Answer These Questions for You…
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How does Europe’s new IVDR differ from the old IVD Directive?
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What clinical and performance requirements are imposed by the IVDR?
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What is the classification of our device(s) under the IVDR?
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How long will it take us to be fully IVDRcompliant?
How We Can Help
Under the In Vitro Diagnostic Directive (IVDD), only a small portion of IVDs were subject to Notified Body audits and CE Marking certification. Not so with the IVDR – most IVD devices will require Notified Body scrutiny and certification in order to be sold in Europe. If you need help making the transition, we can assist with the following:
1. Ensuring Your QMS Meets European IVDR and International Requirements
First things first: Unless you manufacture only low-risk Class A IVDs, compliance with the ISO 13485 quality management system (QMS) standard will be essential. We have guided hundreds of companies through this process, taking a phased approach that accounts for the size of the company, complexity of manufacturing, and availability of internal resources to implement and maintain the system. Learn more about how we help companies with ISO 13485 implementation and auditing.
2. Determining Your IVDR Classification and Road to Compliance
Figuring out your pathway to IVDR compliance starts by understanding the classification of your device. The IVDR introduces an all-new classification scheme, so an important early step is to determine whether your device is Class A, B, C, or D. We will help you do that using Annex VIII of the IVDR.
3. Conducting an IVDR Gap Assessment and Crafting a Transition Plan
Oriel STAT A MATRIX can assist in conducting a thorough IVDD to IVDR gap analysis. With a thorough gap analysis completed, our team will provide a detailed roadmap for transitioning to the IVDR. We can also help you close the identified gaps one at a time, focusing on the areas that pose the greatest risk and impact on compliance.
4. Getting Your IVD Technical Documentation in Shape
Many IVD manufacturers may not have adequate clinical and performance data required for IVDR compliance. We will examine all of your existing data, including:
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The device’s intended use
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Design and manufacturing information
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Benefit/risk analysis
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General safety and performance requirements (GSPR)
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Performance evaluation data, including:
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Analytical performance
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Analytical performance
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Scientific validity (including state of the art)
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Labeling and indications for use (IFU)
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Standards applied
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Postmarket surveillance (PMS) processes and data
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Postmarket surveillance (PMS) processes and data
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And much more
We will 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, testing houses, or even your Notified Body, we can assist with that as well.
We Are Ready to Help
Let our IVDR consulting team help prepare your company for the In Vitro Diagnostic Regulation (2017/746). Contact us today to learn more or request a proposal.