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Regulatory Affairs
IVDR - what has changed from IVDD?

This article discusses the upgrade from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR), which introduces new requirements for analytical performance, clinical performance evaluations, scientific validity and post-market surveillance to improve the safety and performance of in vitro diagnostic medical devices. The IVDR also focuses on risk-based classification, increased scrutiny of clinical evidence, stricter requirements for post-market surveillance, unique device identification, greater transparency and traceability, and strengthening of Notified Bodies.

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By
Arni Viggosson
Published on
July 12, 2023
Updated on
March 7, 2023
Table of Contents

The upgrade from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) was driven by several factors, including advances in technology, changes in the healthcare landscape, and concerns about patient safety.

Firstly, the introduction of technologies including software and algorithms for diagnostic solutions has accelerated since 1998 when the IVDD was first introduced.  The previous regulations were no longer adequate to address the increasing complexity of in vitro diagnostic medical devices. The IVDR introduces new requirements for analytical performance, clinical performance evaluation, scientific validity and post-market surveillance, which aim to improve the safety and performance of IVDs.

Secondly, changes in the healthcare landscape, such as the growing demand for personalised medicine and the increasing use of IVDs in clinical decision-making, have also driven the need for more robust regulations.  This includes the new IVDR requirements for companion diagnostics.  Companion diagnostics are those used to monitor patient’s disease progression and have been used to identify patients who are most likely to benefit from a specific treatment, based on their genetic profile.

Lastly, there have been concerns about patient safety with IVDs, particularly in cases where the device has been used improperly, or, where the device performance has not been adequately evaluated. The new regulations aim to address these concerns and improving the quality and safety of IVDs, by introducing stricter requirements for market access, post-market surveillance, and risk management.

Below we summarise the most significant improvements, brought about by the IVDR.

  1. Greater focus on risk-based classification: the IVDR introduces a risk-based classification system for IVDs, which places greater emphasis on the potential risks associated with a particular device. This means that devices that pose a higher risk to patients will be subject to more rigorous regulatory requirements, including stricter pre-market evaluations, more comprehensive performance testing, and more extensive post-market surveillance.
  1. Increased scrutiny of clinical evidence: the IVDR requires a higher level of clinical evidence for IVDs than was required under the previous regulations. This means that manufacturers will need to provide more comprehensive data on the safety and performance of their devices, including data from clinical studies, to demonstrate that their devices are safe and effective.
  1. Stricter requirements for post-market surveillance: the IVDR requires manufacturers to monitor the performance of their devices after they have been placed on the market and to report any adverse events or safety concerns to regulatory authorities. This will enable regulatory authorities to take swift action to address any safety issues that arise, and to ensure that IVDs continue to perform as expected over time.
  1. Introduction of Unique Device Identification (UDI): The IVDR requires that all IVDs carry a unique device identification (UDI) code, which will enable regulatory authorities to track devices more easily and improve post-market surveillance.
  1. Greater transparency and traceability: the IVDR introduced new requirements for labelling, packaging, and instructions for use, which aim to improve the transparency and traceability of IVDs. This included requirements for the provision of information on the intended use of the device, target population and any limitations or warnings associated with its use.
  1. Strengthening of Notified Bodies: the IVDR introduces stricter requirements for Notified Bodies, which are the organisations responsible for evaluating and certifying medical devices. Notified Bodies will need to demonstrate that they have the necessary expertise and resources to carry out their duties effectively and will be subject to more rigorous oversight by regulatory authorities.

Overall, the IVDR represents a significant upgrade to the previous regulations and is designed to improve the safety and performance of IVDs, while promoting innovation and ensuring that patients have access to the most effective diagnostic tools available.

If you have any further questions about the IVDR certification process, please reach out to us through this link and one of PeploBio‘s regulatory team will get back to you within 3 business days.

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