The initial question whether a devise is a medical device or not - and, if so, what type of medical device it is - depends on the classification of such medical device, meaning as higher the class as stringent the regulatory requirements. We can help you determine the correct class, either through our online tool or directly in a personal meeting.
The steps to classification are as follows:
- Medical devices, non-medical devices, and supplies: It must be clarified whether the product is classified as a medical device, non-medical device, or medical supply according to the definitions of the Medical Devices Regulation (MDR). Depending on the classification, the corresponding regulations of medical device law must be observed.
- Medical device, in vitro diagnostic device, active implantable medical device: The decision on the classification of the product type as medical device, in vitro diagnostic medical device or active implantable medical device can be made relatively easily. Depending on the classification, the applicable EU directive (MDR or IVDR) is determined.
- Classification according to MDR: Medical devices that fall under the European Medical Device Regulation must be assigned to one of the classes I, I* (Im, Is, Ir and combinations thereof), IIa, IIb or III. The classification rules can be found in Annex VIII according to the MDR. Experience shows that about 70% of all medical devices fall into class I. The classification determines the required conformity assessment procedures for the product.
- Safety classes according to IEC 62304 (software): Here, safety classes A, B and C are determined, depending on the severity of possible damage caused by the software. The influence and extent that the software used has on the medical device is considered.
