As a dealer with Medical devices (MD), the law (MDR) has imposed duties of care, testing and information on us in § 14 dealer obligations, which go beyond the normal scope of trading in everyday products (socks).

Specifically, these obligations include:

Testing obligations (testing before market provision):

Does the product bear the CE mark and has a declaration of conformity been issued?

Does the product come with the information provided by the manufacturer?

Has a UDI code been assigned by the manufacturer?

Is the medical device marked with a use-by or production date?

Storage and transport condition:

You will find the specifications for the correct storage of the products as a note in the instructions for use that accompany each medical device. There are no special conditions for transport.

Information obligations and post-market monitoring (follow-up):

If the distributor receives complaints from healthcare professionals, patients or users about suspected incidents related to a product, it must immediately report this to the manufacturer. The retailer keeps a register of complaints, non-compliant products, recalls and withdrawals. They keep the manufacturer informed and provide them with any information they request. Likewise, the distributor must provide the competent authority, upon request, with all the information and documents in his possession that are necessary to demonstrate the conformity of the product.

Note on Medical devices (MD) in our shop:

A medical compression stocking (MD) whose size selection turned out to be "too small" after wearing it or already trying it on and later measuring it has thus been "overstretched" beyond the permissible sizes assigned to the product and is therefore no longer "safe" in the intended use and can then only be disposed of.

	Clear indication of the period within which the product can be used safely. Year-Month shows the end of the month here. Is the remaining period of use (best before date) sufficient for 6 months? For products from SIGVARIS the date indicates the end of shelf life. After this date, a maximum period of use of another six months begins.
	One-time delivery, multiple use
	Indication of the date of manufacture
	Notice that it is a medical product
	Name and address of manufacturer
	Unique Device Identifier - UDI

The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components

• a device identifier (UDI-DI)
• a production identifier (UDI-PI)

These provide access to useful information about the device. The specificity of the UDI

• makes traceability of devices more efficient
• allows easier recall of devices
• combats counterfeiting
• improves patient safety

The UDI will be an addition to, not a substitute for, the existing labelling requirements for medical devices.

Source: Unique Device Identifier - UDI - European Commission

Currently, a 'UDI' is also being applied to non-medical devices. We are in the process of classifying this and will point it out for each affected product.