Medical Device Regulation: HARTMANN products available long-term and secure


Company already complies with all requirements of the EU Medical Device Regulation (MDR):

  • Quality and regulatory systems fully converted to MDR
  • Long-term product availability guaranteed
  • Safety also for new and significantly changed products

Heidenheim, February 9, 2023. PAUL HARTMANN AG has already today completely transferred all product groups to the new EU Medical Device Regulation. The planned deadline extension by the EU is thus not relevant for the company. HARTMANN is further strengthening its supply abilities: the company's customers can rely on their products, being safe and available in the long term including new and significantly changed products.

HARTMANN already started implementing the MDR in 2017 and worked together with TÜV SÜD as the Notified Body at an early stage. "For us, a speedy implementation of the MDR was crucial. After all, our customers should be able to focus on their patients, not on regulatory requirements. We take care of that for them," says Stefan Fischer, Global Head of Regulatory Affairs at HARTMANN GROUP.

Products that are safe in the long term

The changeover process at HARTMANN included building up stocks of MDR-compliant products. This enables the company to ensure a continuous supply of safe products approved according to MDR. HARTMANN can already enter into long-term agreements and contracts with its customers and suppliers without any restrictions. "This is particularly important for long-running tenders, as the MDR deadline extensions still leave uncertainties," Stefan Fischer continues.

Advantages for new and significantly changed products

Companies that, like HARTMANN, are already fully MDR-compliant can also bring innovations, product adaptations and improvements to the market in a simplified manner, because they no longer have to comply with the Medical Device Directive (MDD) as well. In contrast, companies without MDR implementation require individual approvals from a Notified Body. “Our employees can now focus more on new products instead of complying with parallel regulations,” says Stefan Fischer, describing the situation.

With further regulations ahead of schedule

HARTMANN is ahead of schedule in the implementation of other regulatory requirements, such as the European Regulation on In Vitro Diagnostics and the European Regulation on Biocidal Products. Says Stefan Fischer: "As with the MDR, we are sticking to our implementation plans so that customers can stick to their care plan and not run into supply bottlenecks."


Currently, many companies are still subject to different regulations for the certification of medical devices running concurrently: In addition to the EU Medical Device Regulation MDR, there is also the previous Medical Device Directive MDD. However, the deadline extension only applies to products for which the manufacturer has issued a declaration of conformity by May 26, 2021 at the latest. For any new product that was not previously marketed under their MDD, the requirements of the MDR will apply directly and immediately. In addition, companies that have not signed a contract with a Notified Body by the beginning of 2024 will not be able to benefit from the MDR extension.


Die HARTMANN GRUPPE ist ein führender europäischer Anbieter von Systemlösungen für Medizin und Pflege. Medizinisches Fachpersonal und Patienten verlassen sich jeden Tag auf HARTMANNs Produktmarken in den Segmenten Inkontinenzmanagement (u. a. MoliCare®), Wundversorgung (u. a. Zetuvit®, Cosmopor®) sowie Infektionsmanagement (u. a. Sterillium®). Dies bringen wir mit unserem Markenversprechen „Hilft. Pflegt. Schützt.“ zum Ausdruck. HARTMANN erzielte im Geschäftsjahr 2023 einen Umsatz von 2,3 Mrd. EUR. Das 1818 gegründete Unternehmen ist mit seinen Produkten und Lösungen in mehr als 130 Ländern präsent. Die HARTMANN GRUPPE setzt aktuell mit ihrem leistungsstarken, kundenorientierten und leidenschaftlichen Team ihr strategisches Transformationsprogramm für die Zukunft um.

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