The In Vitro Diagnostic Regulation (IVDR) is the new EU legislation that applies to in vitro diagnostic (IVD) medical devices.
From May, 2017 until May, 2022, IVDR is in its five-year transition phase, replacing the EU In Vitro Diagnostics Directive (IVDD) that has become outdated in light of the innovation and growth within the industry.
A notified body (NB) will perform a conformity assessment of your IVD medical device documentation. You have until May, 2022 to update your Technical Documentation to meet the necessary requirements and comply with the new set of regulatory expectations.
It is important for you to have a thorough understanding of the IVDR before applying for conformity assessment to CE mark your device and place it onto the EU market.
A key part of IVDR compliance is a thorough performance evaluation of the in vitro device. The performance evaluation is a continuous process that demonstrates scientific validity, analytical and clinical performance of an IVD.
The Performance Evaluation Report (PER) should include:
We are using our own well-structured and customizable templates that undergo continuous improvements by incorporating new guidance as soon as it is published. This ensures that your performance evaluation plan (PEP) incorporates all latest requirements.
We ensure that clinical evidence for your device is critically appraised and presented in a clear, consistent, and concise manner, proving its intended purpose and safety claims, when used as intended.
At Evnia, we implement a thorough, validated, multi-step process to develop a State-of-the-Art discussion, fulfilling all requirements of the IVD Regulation.
We use various customized tools, enabling our experts Medical Writers to develop a tailored search strategy that will:
Evnia will ensure that you are submitting a high-quality performance evaluation that complies with IVDR requirements, as well as identifying unknown or unmitigated risks, associated with your in-vitro diagnostic medical device.
You get complete IVDR services that ensure:
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