HARTMANN: Further successful MDR audit - upcoming regulations already in the works

Heidenheim, Aug. 20, 2021 - The European Union's new Medical Device Regulation (MDR) officially came into force on May 26, 2021. In July 2021, the HARTMANN GROUP already underwent its second audit by its key Notified Body TÜV SÜD. Once again, the audit procedure was completed positively. The Company is now already preparing for the implementation of the upcoming regulations, the new EU regulation on In Vitro diagnostics (2022: In Vitro Diagnostic Medical Device Regulation, IVDR) and the Biocidal Products Regulation (2026: Biocidal Products Regulation, BPR).

Due to the coronavirus pandemic, the start of the MDR was delayed by a full year to 2021. All companies in the industry will have to apply the new MDR on a mandatory basis starting May 26, 2021. Already, Class 1 non-sterile medical devices (e.g. absorbent incontinence products) may only be placed on the market in accordance with the MDR. For medical devices of higher risk classes (including classes IIa to III) with a previously issued certificate under the Active Implantable Medical Device Directive (AIMDD) or under the Medical Device Directive (MDD), there is a three-year transition period until May 26, 2024. HARTMANN was already "MDR-ready" by the end of 2019 due to early preparation for the new regulatory framework and has now issued several hundred Class I declarations of conformity. The most important higher-class products were already submitted to TÜV SÜD in May 2021. "For HARTMANN, early implementation of the MDR was crucial. After all, our customers should take care of their patients, not regulatory requirements. This is what we are taking on," reports Stefan Fischer, Global Head of Regulatory Affairs at the HARTMANN GROUP.

After the successful MDR rollout, HARTMANN is already focusing on the upcoming regulatory requirements. "One success factor with the MDR is that we have a renowned partner in TÜV SÜD. This is all the more important as the number of Notified Bodies auditing companies is constantly decreasing and certifications are stalling. However, our goal is always to prepare for new regulations at an early stage," continues Stefan Fischer. New regulations are constantly appearing worldwide that have to be applied to HARTMANN products. These include the new EU In Vitro Diagnostic Medical Device Regulation (IVDR) and the Biocidal Products Regulation (BPR).

New in vitro diagnostic devices and in vitro diagnostic devices without a valid IVDD certificate will have to comply with the requirements regulated in the IVDR from May 26, 2022. HARTMANN, as a distributor and importer in this area, anticipates complex and time-consuming changes for the manufacturers of these products. For example, a new classification system with risk classes A to D applies under the IVDR. Class A classifies products with the lowest level of risk, such as general laboratory supplies like test tubes or tubing, and Class D classifies products with the highest level of risk. From now on, the IVDR defines rules on how to classify individual products and no longer provides exhaustive lists. Furthermore, the Notified Body will be more involved in the approval process of in vitro diagnostic devices. It is expected that in the future it will no longer test only 15 percent of the products, but up to 90 percent. The IVDR also introduces a new Unique Device Identification (UDI) system, similar to the MDR, which will make it easier to trace products through the supply chain. Last but not least, stricter rules apply to technical documentation and clinical evaluation with the new IVDR.

Another area of work is the BPR. It regulates the approval of biocidal products, for example, disinfectants such as HARTMANN's own Sterillium Protect & Care. In a two-stage process, first the active ingredients are approved and then the biocidal product as such. Here, too, the additional effort is considerable; a new approval must be applied for all disinfection products and some of their active ingredients. HARTMANN has already submitted the dossiers for the first product families to the approval authorities. "HARTMANN has acquired a great deal of expertise in regulatory tasks in recent years. Our company places a very high value on this in order to support customers with product and delivery reliability, but also with advice. We are therefore confident that we will be able to comply with the upcoming regulations at an early stage," concludes Stefan Fischer.

All further information on regulatory topics at HARTMANN can be found at hartmann.info/regulatory.

About the HARTMANN GROUP

The HARTMANN GROUP is a leading European provider of system solutions for medical applications and nursing. Healthcare professionals and patients rely every day on HARTMANN's product brands in the core segments of Incontinence Management (including MoliCare®), Wound Management (including Zetuvit®) and Infection Prevention (including Sterillium®). We bring this to life with our brand promise: "Helps. Cares. Protects." In 2020, HARTMANN achieved sales of EUR 2.4 billion. Founded in 1818, the company is present with its products and solutions in more than 130 countries. The HARTMANN GROUP is currently implementing its strategic Transformation Program with its high-performance, customer-oriented and passionate team.

Please find the latest information about HARTMANN, as well as our perspective on various healthcare topics and trends at https://hartmann.info/ or HARTMANN@LinkedIn.