EU 745/2017, also known as the Medical Devices Regulation (MDR), is a regulation that governs the marketing and distribution of medical devices within the European Union. It sets out the requirements and standards that medical devices must meet to ensure their safety and performance.
To determine whether a specific product like a silver nursing cup falls under the scope of the MDR, you would need to consider its intended purpose and whether it meets the definition of a medical device as defined by the regulation. According to the MDR, a medical device is any instrument, apparatus, appliance, software, material, or other article used alone or in combination, including accessories, intended by the manufacturer to be used for human beings for various medical purposes.
If the silver nursing cup is intended for medical purposes, such as assisting with breastfeeding or providing therapeutic benefits, it may be considered a medical device and subject to the requirements of the MDR. In that case, it would need to comply with the relevant provisions, including conformity assessment procedures, CE marking, and post-market surveillance obligations.
English
