Clinical trials for medicinal products and IVDs: interface between two Regulations

The Medical Device Coordination Group (MDCG) published a Q&A document on the interfaces between two Regulations. Specifically, the Regulations involved are the Regulation on clinical trials for medicinal products for human use (CTR) and the Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). The aforementioned MDCG document adds to already issued Q&A document concerning the implementation of the CTR Regulation, which was updated recently (May 30, 2022).

The medical purpose of an assay in a clinical trial

In particular, the publication aims to clarify the requirements for assays used in clinical trials. In clinical trials, the assays used vary from CE marked in vitro diagnostic medical devices (IVDs) to trial- or medicinal product-specific assay. However, the latter is not always meant to be developed as IVDs. The necessity to clarify the concept of the “medical purpose of an assay in a clinical trial” for such situations led to this MDCG Q&A document. As such, the document includes a glossary on key terms under both regulations, such as “Performance Study Plan”, “Clinical Trial Application (CTA)”, “Combined Trial”, or “Clinical Trial”. 

After providing more light on the definition of these terms, the MDCG document addresses multiple questions such as:

  • Can I use an in-house IVD in a clinical trial?
  • When does an assay used on human samples qualify as an IVD in a clinical trial?
  • What are examples of assays used in clinical trials, which are IVDs?
  • In which situations may a non-CE marked IVD (or an IVD that is CE marked for another intended purpose) be used in a clinical trial for a medical purpose according to the IVDR?
  •  Is there a common EU procedure for combined trials?
  • What are the notification/application requirements for the performance study according to the IVDR?

Detailed answers are provided to give more clarity to those manufacturers interested in initiating clinical trials with borderline medical devices.

Do you wish to know more about the In Vitro Devices Regulation (IVDR)? You can find these and other relevant guidances for your devices in our MDlaw Library.

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