MDR: we take care of it.

As of 26 May 2021, MDR regulations are fully in effect. HARTMANN is ready and MDR compliant products are already on the way to customers.

HARTMANN: a MDR pioneer

MDR was created to improve the safety, traceability and transparency of medical devices in all EU countries. As of May 26, 2021, MDR applies for all partners involved in healthcare. It marks an important step that will result in improved transparency and traceability of all medical devices and in greater patient safety.

New regulations also mean changes in procurement processes, in documentation and also in the products used, which could result in product delivery delays or even cancellations. Not at HARTMANN, however.

HARTMANN is one of very few companies in the market with a clear MDR action plan that we have been following for years. In addition, we work closely with our key Notified Body TÜV SÜD. We can already: We are "MDR ready".

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Which HARTMANN products are affected by MDR and when?

We had already converted 98% of our Class 1u products by the original deadline of May 26, 2020 (it was pushed up to 2021 due to the coronavirus pandemic). For all other, higher-class products, a timely conversion is planned latest by 2022.

In general, our Class I devices non-sterile (e.g. incontinence products) are compliant (deadline was May 26, 2021). All other new medical devices must be MDR compliant by 2024 – HARTMANN objective is to be MDR-compliant by 2022.

For Class I sterile, Class IIa, IIb and III medical devices, HARTMANN is well on track to carry out the studies and documentation required to recertify products on time.

How do I know if a product is MDR compliant?

This is the question most healthcare partners are asking. Other questions you should be asking your suppliers and manufacturers:

  • Do you have a Notified Body accredited under MDR?
  • Do you have a date for certification?
  • Are you already MDR certified?
  • Have you already declared the conformity of the products according to MDR?

You should only be buying medical devices from sources who can give a resounding yes to all four questions. HARTMANN, of course, is one of the few suppliers who can answer positively and whose products already bear the MD symbol.

Don’t take a wait and see approach! Think ahead and buy compliant today! Contact us and we’ll help you find the MDR compliant products you need today.

MDR and UDI: today and in the future

Economic operators will need to be able to trace the path their products took for at least 10 years. Additionally, all healthcare partners and customers will need to be able to quickly trace a medical device. In the future, a UDI (Unique Device Identification) will be used. Medical devices must be marked with an automatically readable identification code. This will ensure optimal traceability of the medical device and optimal transparency for the user and patient.

Questions about MDR?

Don’t worry, HARTMANN has the answers. Check out our FAQ for some quick insights or feel free to contact our HARTMANN team.