Medical devices and (in) clinical trials: confused?!

The new EU Clinical Trial Regulation (CTR) N.536/2014 is in a transition period until the 31st of January 2025; but, for manufacturers there should be no delay in transitioning to the new rules.

The new Clinical Trial Information System (CTIS) went live in the beginning of this year, so if you are the sponsor of a clinical trial of a medicinal product in the EU/EEA, the opportunity is there to be compliant as soon as possible.

Much confusion exists regarding the use of medical devices in clinical trials and which rules apply to what. Recently, a quick guide was released by the Clinical Trials Coordination and Advisory Group (CTAG) to clarify some issues regarding the new CTR rules, and also to answer some doubts from manufacturers with a direct Q&A. 

As such, in case a medical device is involved in a clinical trial, then three possibilities arise:

- The object of the study is one integral product which is a "combination" of a medical device and a medicinal product. In this case, emphasis is made on the principal mode of action, and the full CTR applies;

- The object of the study is a medicinal product; however, during the clinical trial medical devices are used without these being the object of the study. In this case, the full CTR applies; and the medical devices used in the clinical trial must comply with the medical device regulation (MDR) EU-rules for placing the product into the market;

- The object of the study is two separate products: one “arm” is a medicinal product, and the another “arm” is a medical device. In this case, the CTR applies to the medicinal product “arm” and medical device conformity assessment EU MDR apply to the other “arm”.

So, as a sponsor besides carefully assessing the relevance and feasibility of the planned clinical trial, please pay attention to the above three possibilities to define the ground of compliance that needs to be achieved.

In case you need more information, contact us at BioSciPons...
Catarina Carrão