Jun 2, 2022

Now that the IVDR 2017/746 has taken effect, new guidance for in vitro diagnostic (IVD) manufacturers with assays used in clinical trials has been published. Assays used in clinical trials may range from CE Marked IVDs to trial- or medicinal product-specific assays that aren’t always meant to be sold as IVDs.

The IVDR replaces an earlier Directive, the IVDD, and significantly strengthens the rules for placing medical tests on the EU market. In January 2022, the European Parliament and the Council amended the transitional provisions of the IVDR for IVD devices already on the market. The amendment allows for transition periods for compliance with the new rules based on the risk class of the device.

How does Regulation (EU) 536/2014 work within the framework of IVDR 2017/746?

The need to clarify certain requirements for these assays led Europe’s Medical Device Coordination Group (MDCG) and Clinical Trial Expert Group (CTEG) to introduce a collaborative Q&A that clarifies certain interfaces between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and IVDR 2017/746 for in vitro diagnostic medical devices.

Assays used in clinical trials may range from CE Marked IVDs to trial- or medicinal product-specific assays not meant to be developed as IVDs. Non-interventional studies, defined as clinical studies other than a clinical trial in Article 2 (4) of the CTR are out of the scope of both the CTR (as per Article 1). These IVDs are subject to the IVDR.

The new IVDR rules on medical testing devices, such as those that diagnose COVID-19, HIV or pregnancy, will better protect patient safety, bringing EU law in line with technological advances in medical science. The new rules under IVDR also harmonize requirements among the different EU Member States, which protects fair market access for manufacturers.

How does the IVDR use advances in medical science to protect public health?

There are three ways the IVDR utilizes medical science advances to improve patient safety when using these diagnostic medical devices.

IVDR leverages medical advances to:

  1. Improve IVD medical device quality, reliability and safety. The IVDR introduces a new risk-based device classification system, more stringent rules on device performance, and increases involvement of independent conformity assessment bodies (Notified Bodies). This paves the way for new scientific bodies, such as a panel of experts and EU reference laboratories to assess the highest-risk devices.
     
  2. Increases information and transparency for patients. New IVDR rules will make it easier for patients to find vital information. The European database of medical devices (EUDAMED) will display details on all IVD devices on the market, including economic operators and certificates issued by Notified Bodies. A unique device identifier is now mandatory for all products so that they can be referenced in EUDAMED. A summary of safety and performance for all medium- and high-risk devices will be available to the public.
     
  3. Enhances vigilance and market surveillance. Manufacturers of IVD devices on the market will have to collect performance data. EU countries will closely coordinate their vigilance and market surveillance activities.

Emergo by UL will post updates to EU IVDR guidance as it becomes available.

Learn more about IVDR regulations and compliance in the EU from Emergo by UL:

  • MDR and Annex XIV: the crucial role of clinical evaluation reports webinar
  • European Authorized Representative for clinical trials in-country representation services
  • Medical device clinical trial management and monitoring service
  • IVD medical devices clinical performance evaluation studies white paper

Author

  • Kathryn Burke's picture
    Kathryn Burke

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