The first document a notified body will assess when they receive the technical documentation from a manufacturer, is the justification for the status of a medical device or IVD and the risk class. That is the document that will create your very first impression. In case of borderline products or devices with a classification that looks unusual (e.g. needle in Class I, Sterile – they really exist!), these justifications can prevent a company attracting unnecessary attention by the authorities.
Borderline & Classification
For most products their status and, in case they are medical devices or IVD’s, their risk class is obvious. Or is it…? The devil can be in the detail. Some examples:
- A multi component device used in the surgical procedure included a container in which tissue could be send to the hospital laboratory for further investigation. Although the full device would qualify as a medical device, there was a component that would qualify as an IVD. This was overlooked by the regulatory team, only to be discovered by the notified body.
- A suction device operated by pressing on a small balloon, that would flex back when that pressure was released, was considered a medical device of Class I, Self-Certified. However, the balloon could be considered a spring and its operation was depending on muscle force being converted into a lowered pressure inside the balloon. This was considered an active medical device of Class IIa.
- A hospital was experimenting with administering a substance to patients undergoing cancer treatment. In the first experiment this substance was used to identify the location of lymphatic glands in a specific area, so they could all be removed. In the second experiment the substance was used to identify lymphatic glands that were at risk of being affected by the cancer. In the first experiment that substance was used to identify an anatomic feature, it was used as a medical device. In the second experiment it was used for diagnostic purposes and it had to be considered a medicinal product.
Justification and/or borderline support
Boumans Regulatory Consulting can review the status and classification of your devices as well as your justifications. Because this justification is the first impression you make on your notified body reviewer, you want this justification to look perfect. Boumans Regulatory Consulting can draft rock solid justifications, or assist your team in writing them. In cases of doubt or clear borderline situations, Boumans Regulatory Consulting can assist in creating a justifiable product status or classifiation.