Medical Device without CE mark

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We would like to ask you if one Medical Device(Dental Instruments Class I) is Non-CE Marked, is there any possibility to sell them in EU in shopify.

In case we sell our Medical Device directly to the clients(Dentists or Medical Professionals) through Shopify, we guess Medical device might be like a customised products since it reach to the dentists who purchased ONLY.

Does this mean "in the market" or no ?

Replies 2 (2)
Shopify Partner
143 13 21

You need to discuss that with a legal expert who is versed in the sale of medical equipment. Shopify can't tell you if something is legally possible to sell. If you decide to do it anyway and it does break the law then you'll end up getting your store locked, so better to do it the right way 🙂 

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The discussion surrounding a "Medical Device Without CE Mark" is crucial for ensuring public safety and quality healthcare. When it comes to healthcare, especially in specialized fields like dentistry, adhering to regulatory standards is of utmost importance. In the context of dental care, maintaining the highest standards like those provided by VIP Dental Care is essential to guarantee the well-being of patients. While the absence of a CE mark might raise concerns, it also underscores the importance of rigorous quality checks and certifications. This discussion can ultimately lead to improvements in medical device regulations, ensuring that patients receive the best possible care.