Is your device or software a medical device?

Any instrument, apparatus, appliance, software, implant, reagent, material, or another article can be a medical device. An app, therefore, can also be a medical device. The extensive definition of medical device is given in article 2 of the MDR.

The determination of whether something is a medical device is based on the intended (medical) purpose. The intended purpose describes what the product is designed to do. Therefore, it is recommended to first establish an intended purpose for the product. Consider how the product will be put on the market, for which user group and/or patient group it is intended and which claims will be made on the website and in advertising material.

Note: The MDR designates medical device accessories (e.g. attachments and accessories) and a special group of non-medical products (described in Annex XVI of the Regulation) also as "medical devices". Therefore, they also have to meet the requirements of the MDR and obtain CE certification before they can be placed on the market.

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