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Medical Devices

Medical Device Regulation (MDR)

The MDR (Medical Device Regulation) is a European regulation for medical devices that entered into force at the end of May 2017 (EU 2017/745). After a transitional period extended due to the coronavirus pandemic, the requirements are to be applied by May 26, 2021, at the latest. Both manufacturers of medical devices and those placing them on the market must implement significant changes by this date at the latest.


At SerraNova we work with our manufacturing partners to ensure that all products supplied for medical purposes are MDR compliant.  

What are the visible effects of the MDR?

According to the MDR, expanded information is required for the labeling of medical devices. In the future, in addition to the code that uniquely identifies the products, you will find additional data and symbols on the packaging and label. Products under the responsibility of a manufacturer or distributor can be identified by a black factory symbol on the label or packaging at our address:

    What exactly are the requirements for product labeling?

    In addition to the well-known CE mark, you will find some new symbols on your garments:  

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    Explanation

    Expiry date:

    From the date of entry into force of the MDR, products must contain a manufacturing or expiration date. Our breast forms and Form Care products will carry an expiration date. The expiration date will be determined based on shelf-life studies.
    Expired products may no longer be sold.

    Date of manufacture (= shipping date):

    From the effective date of the MDR, products must display a manufacturing or expiration date. Our Recovery Care and other textiles will display a manufacturing date.
     

    Reference number:

    Symbol is displayed before the article number
     

    Serial number:

    Symbol is displayed before the serial number
     

    Production batch number:

    Symbol is displayed before the production batch number
      The "MD" symbol stands for Medical Device - this symbol is displayed to indicate that the product is a medical device.
      Single patient - multiple use: The product can be used multiple times by only one patient.
      Read further information in the instructions for use
      If the packaging is damaged, the product must not be used
      Products that are under the responsibility of a distributor or manufacturer in Europe can be identified behind a black factory symbol on the label or packaging
      Protect the products from sunlight
      Store the products in a dry place

     

    What about the instructions for use?

    In the highly unlikely event of a "serious incident" involving a medical device in our risk class, we are legally obligated to include a reporting obligation in the instructions for use. Furthermore, as required by the MDR, you and your customers will also find our current instructions for use on our website by the deadline at the latest.

    If you have any further questions about the MDR, please do not hesitate to contact us.