Qualification and classification
The manufacturer is responsible for determining whether the device qualifies as medical devices. If the answer to this is "YES," the next step is to determine the risk class of the device.
Does the device qualify as a medical device?
The decision of whether something is a medical device should be based on the manufacturer's intended purpose for the product (as per "intended purpose" in MDR/IVDR Article 2 (12)). The purpose should be assessed against the legal definition of medical device provided in MDR Article 2, and for in vitro diagnostic (IVD) medical devices, the definition of IVD medical device given in IVDR Article 2. The product's purpose should also be consistent with the mechanisms of action and claims associated with the device during marketing.
The risk class is determined by the manufacturer comparing the intended purpose against a set of classification rules. For medical devices, the classification rules are found in MDR Annex VIII, and for IVD medical devices, in IVDR Annex VIII.
For more information on risk classes for medical devices and IVD medical devices, please refer to our page on classification.