In-Vitro Diagnostics Regulation (IVDR)

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2022, IVDR is in its five-year transition phase, replacing the EU In Vitro Diagnostics Directive (IVDD) that has become outdated in light of the innovation and growth within the industry.

In Vitro Diagnostic Regulation

Who audits IVDR

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.

who audits CER
clinical evaluation report

What you need to be successful

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:

  • Justification for the approach taken to gather the clinical evidence;
  • Literature search methodology, protocol and report of a review;
  • Technology on which the device is based, the intended purpose of the device, and any claims made about the device’s performance or safety;
  • Nature and extent of the scientific validity, as well as the analytical and clinical performance data that has been evaluated;
  • Clinical evidence as the acceptable performances against the state-of-the-art in medicine;
  • Any new conclusions derived from Post-Market Performance Follow-Up reports in accordance with Part B of Annex XIII

How Evnia helps

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:

  • Identify the intended field and similar devices
  • Retrieve scientific evidence confirming your device’s labelling statements or helping you to revise them
Doctor's desktop with medical equipment, computer and X-ray of human lungs.
CER

What you get

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:

  • You prepare your PEP and PER, making sure that your in-vitro diagnostic medical device is in compliance with the General Safety and Performance Requirements, set in Annex I of IVDR
  • You’re guided through the preparation of the respective Technical Documentation as per Annexes II & III of the IVDR

Need more details?

We are here to assist. Contact us by phone, email or via our Social Media channels (Twitter or LinkedIn).

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