bg-country-switch bg-country-switch

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.

The HARTMANN GROUP is one of the leading European providers of professional medical and care products and associated services. Every day, healthcare professionals and patients rely on HARTMANN brands in the segments of Incontinence Management (e.g. MoliCare®), Wound Care (e.g. Zetuvit®) and Infection Management (e. g. Sterillium®). This is expressed in our brand promise of “Helps. Cares. Protects.” In 2021, the HARTMANN GROUP reported Group sales of EUR 2.3 billion. Founded in 1818, the company sells its products and solutions in 130 countries around the world. For the future, the HARTMANN GROUP is currently implementing its strategic Transformation Program with its high-performance, customer-oriented and passionate team.