Medical Device or Not?

A company has designed a special type of imaging scanner for confirming tumors ablation directly in the Operating Room.

On the market, there is already a product with a handpiece that the surgeon can use directly in the surgical field for detecting remanent ionizing emission from pre-exposed tissues. This device is classified as a medical device.

In the considered case, however, there is no handpiece and the imaging scanner rather evaluates a sample of tissue collected from the patient.

After analysis, it appears that although the two devices have a similar purpose, the marketed product is a medical device as per 93/42 directive and MDR and the new imaging scanner is an IVD as per 98/79 directive and IVDR.

This difference implies different applicable standards and a way easier initial pathway to the market because the new product can be CE marked by the means of an auto-certification under the 98/79 IVD directive.