Medical Devices under the MDR: Mandatory Information in Your Shop
The Medical Device Regulation MDR (Regulation (EU) 2017/745) sets high requirements for the distribution and labeling of medical devices. In the online shop, too, the intended purpose, UDI, and mandatory notices must be declared.
Also relevant around mdr regulation, sell medical devices, udi labeling, ce marking medical device.
What Medical Devices MDR Online Shop means
The MDR requires medical devices to be CE marked, to carry a unique device identifier (UDI), and to be provided with a clear intended purpose as well as safety and usage notices. This information must also be available in online sales.
Who it applies to
Retailers of medical devices such as dressings, measuring devices, aids, or in-vitro diagnostics, including importers, are affected.
What must be shown in the shop
- Intended purpose of the product
- UDI (Unique Device Identifier)
- CE marking
- Safety and usage notices
How ShopCompliance solves this automatically
ShopCompliance stores the intended purpose, UDI, and mandatory notices per product and displays them in a structured way in the listing. That way the MDR information obligations remain met.
Implementing Medical Devices MDR Online Shop in your Shopify store
- 1Record the intended purpose
Enter the intended purpose and the UDI as a unique device identifier for each medical device.
- 2Maintain CE and notices
Store the CE marking as well as safety and usage notices.
- 3Display in a structured way
ShopCompliance renders the intended purpose, UDI, and mandatory notices in a structured way in the listing so that they are recognizable before purchase.
Checklist: Medical Devices MDR Online Shop
- ✓Intended purpose of the product
- ✓UDI (Unique Device Identifier)
- ✓CE marking
- ✓Safety and usage notices
Risks of non-compliance
Medical devices without a valid CE marking or complete mandatory information may not be distributed. Violations of the MDR can be challenged by authorities, sanctioned with fines, and targeted with warning letters by competitors; in the event of safety risks, recalls can occur.
Meet it automatically with ShopCompliance
Activate the Medical Devices MDR Online Shop module in a few clicks. ShopCompliance manages the mandatory information centrally and renders it automatically on your storefront, no theme code.
Open in the Shopify App StoreFrequently asked questions about Medical Devices MDR Online Shop
What is the UDI?+
The Unique Device Identifier is a unique device identifier that ensures the traceability of medical devices.
Do medical devices need a CE marking?+
Yes. Medical devices may only be placed on the market with a valid CE marking.
Must the intended purpose appear online?+
Yes. The intended purpose is among the mandatory information and must be recognizable in online sales as well.
Does the MDR also apply to retailers?+
Yes. Retailers have inspection obligations and may only distribute compliant, correctly labeled products.
Related compliance modules
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The Food Supplements Regulation (NemV) requires special mandatory information such as recommended intake, nutrient quant