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Medical Device Regulation (MDR) “Mastering Device Regulations”

The Julius Zorn GmbH is a manufacturer of medical aids such as compression garments, supports and orthoses. All of our products are medical devices of risk class I and therefore part of the lowest risk class according to the MDR. As a medical device manufacturer of low-risk products, we may, in accordance with Annex VIII of EU Regulation 2017/745 on medical devices, declare the conformity of the devices with the applicable requirements of the Regulation under our sole responsibility and issue the declaration of conformity.

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Graphical representation of various regulatory symbols

The MDR and its impact on distributors

The MDR has, for the first time, identified distributors as economic operators and assignedobligations to the distributor’s role. These obligations are clearly defined in MDR Article 14“General obligations of distributors” and can be divided into three categories: duties ofcare, obligations of verification and obligations of information.

Duty of care

When making a device available on the market, distributors must, in the context of their activities, act with due care in relation to the applicable MDR requirements. This means that distributors must act in accordance with the new requirements set out by the MDR, such as the obligations of verification and information within the context of their business activity, as described in more detail below.

Obligations of verification

Before the distributor makes a device available on the market

Before making a device available on the market, distributors verify that all of the following requirements have been met.

Is the device CE marked and has a declaration of conformity been issued?
All medical devices that are manufactured and made available by Juzo have undergone the conformity assessment procedure in accordance with MDR Annex VIII, have a declaration of conformity and bear the CE marking accordingly.

Is the device accompanied by the information supplied by the manufacturer?
All Juzo devices satisfy the labelling and instructions for use requirements set out in MDR Annex I, Chapter III, No. 23 ff. Every Juzo device is accompanied by instructions for use in 19 languages as standard, containing all the essential information for using the device safely. Further information and identification details are affixed to the product packaging.

Has a UDI code been assigned by the manufacturer?

The UDI identifier (Unique Device Identification) makes consistent tracing possible and is obligatory for risk class I medical devices from 2025, as required by the MDR. Direct marking for reusable medical devices from May 2027. UDI labelling is primarily an advantage in the product chain between manufacturers, retailers and healthcare facilities, e.g. in warehouse management. The UDI code is located on the label in two ways: As an encrypted data matrix barcode with GS1 standard (ISO 15415) for easy scanning and additionally as a readable character string.

The new Juzo identification number for medical devices is made up of two differentcomponents. The item identification is shown using the UDI DI (Device Identifier).The UDI PI (Production Identifier) provides additional production data.

Is the medical device labelled with an expiry date or a date of manufacture?

Under the MDR, manufacturers of medical devices are obliged to indicate an unambiguous time limit for using the device safely. If there is no indication of an expiry date, the date of manufacture must be indicated. The shelf life of the device comprises its storage and usage period. The usage period of the medical device is printed on the adhesive label on the packaging with an hourglass symbol. It must be ensured that only devices with a suitable remaining usage period are given to patients.

During the period in which the device is under the distributor’s responsibility

During the period in which the device is under their responsibility, distributors ensure that storage and transport conditions comply with the conditions set by the manufacturer.

Storage and transport conditions

You will find the requirements for the correct storage of Juzo products as information in the instructions for use which are supplied with every medical device. No special transport conditions apply. Juzo already complies in full with the labelling requirements set out by the MDR. You will find all of the information required on the packaging and the adhesive label. All of the item’s particulars, such as the item name, item number etc. can be found on the adhesive label. All of the symbols that are relevant under the MDR can be found on the back of the device packaging.

Symbole auf einer Juzo Verpackung
You can request an overview of the symbols relevant to medical devices and what they mean at any time, either directly from us or from a sales representative. The list of symbols is also available to download at eurocom-info.de/service/publikationen
Overview of the symbols

After the distributor has made the device available on the market

After a device has been made available on the market, distributors have obligations relating to monitoring and information and they work in cooperation with the manufacturers to achieve an appropriate level of device traceability

If distributors consider or have reason to believe that a device is not in conformity with the Regulation, they must immediately inform the manufacturer. Distributors cooperate with the manufacturer and competent authority to ensure that the necessary corrective action is taken to bring the device into conformity or to withdraw it from the market or recall it. If distributors consider or have reason to believe that a device presents a serious risk, they must also immediately inform the manufacturer and competent authority.

Normal complaints are not serious incidents that need to be reported!

Reporting serious incidents:“Only serious incidents that may lead to a major deterioration in the patient’s health or todeath should be reported to the manufacturer and the relevant authority in the Member State.”Serious incidents are defined in Article 2 (65) of Regulation (EU) 2017/745 (MDR).

Traceability

The traceability of a medical device is a key feature of the cooperation between distributors and manufacturers. Distributors and manufacturers work in close cooperation to achieve an appropriate level of traceability. Traceability is guaranteed by the relevant labelling of the devices with the UDI code on the packaging box and the details on the sewn-in label, which enable complete traceability if required.

Advertising

Distributors are asked, when advertising devices, to adhere to the manufacturer’s advertising statements, especially as regards product features and promises about the effect of the device, and to use the marketing material supplied by the manufacturer wherever possible.

Obligations of information

Distributors that have received complaints from healthcare professionals, patients or users about suspected incidents related to a device must report this to the manufacturer without delay. Distributors must keep a register of complaints, non-conforming devices, device recalls and withdrawals. They must keep the manufacturer informed and provide the manufacturer with all information available to them on request. When requested to do so by a competent authority, distributors must also provide the authority with all information and documentation at their disposal and necessary to demonstrate the conformity of a device.

How this is implemented at Juzo

Labelling

Juzo devices are labelled with the factory symbol. This symbol identifies the manufacturer of the device, thereby indicating who has regulatory responsibility for it.
The MD (Medical Device) symbol identifies the device as a medical device. The MD symbol can be found on the packaging or adhesive label of all Juzo medical devices.
The CE marking for Juzo devices is affixed both to the packaging and the device itself.
The usage period of Juzo medical devices is printed on the adhesive label on the packaging – by year and month (YYYY-MM) – with an hourglass symbol.
Juzo devices must be stored in a dry place and kept away from sunlight. You will find both symbols directly on the back of the packaging box.
Juzo devices must be stored in a dry place and kept away from sunlight. You will find both symbols directly on the back of the packaging box.
The instructions for use for all of the medical devices placed on the market by us are also available under the following link.
The UDI code is printed on the adhesive label on our packaging boxes as well as on our sewn-inlabels. You can find further information in our “New UDI Coding” flyer (Item W160).
The intended purpose of the product is indicated by a symbol on the product packaging and described in detail within the instructions for use.

Declarations of conformity

You can find our declarations of conformity here.

Advertising

We are happy to supply you with advertising materials, such as images and texts, for the marketing of our products. If you are interested, please send us an e-mail to marketing@juzo.de

Do you have any questions about implementing the MDR?

Our Regulatory Team would be happy to help you with any questions you have about implementing the MDR. Just send us an e-mail to regulatory@juzo.de or call us on +49 (0)8251 901 0.

eurocom e.V. (European Manufacturers Federation for Compression Therapy and Orthopaedic Devices) has published various best practice guides on its website to help you implement MDR requirements and which we would like to refer to.

They can be downloaded free of charge at eurocom-info.de/service/publikationen

The best practice guides available here include:

  • Obligations under the MDR in the Medical Aids Sector (FAQ) – Information for Distributors
  • Medizinprodukte – Symbole und ihre Bedeutungen (Medical Devices – Symbols and what
  • they mean)
  • MDR-Praxisleitfaden Umsetzung der UDI (Best Practice Guide on the MDR – UDI
  • Implementation)
  • MDR-Praxisleitfaden Händlerpflichten in der Lieferkette (Best Practice Guide on the MDR –
  • Distributors’ Obligations in the Supply Chain)
  • MDR-Praxisleitfaden Einlagenversorgung (Best Practice Guide on the MDR – Supplying
  • Inserts)
  • MDR-Praxisleitfaden zur Gestaltung bisheriger OEM/PLM-Verhältnisse (Best Practice Guide
  • on the MDR – Organisation of Existing OEM/PLM Relations)
  • MDR-Checkliste Wareneingang (MDR Incoming Goods Checklist)

These guides also provide answers to questions about the MDR, such as:

  • Which general deadlines laid down in the MDR are relevant for distributors?
  • Why does it matter when a product is “placed on the market” and when is a product regarded as “placed on the market”?
  • What obligations do distributors have with regard to the traceability of devices?
  • Will distributors have to register in EUDAMED?