What, when and how: the regulation news

Our Head of Regulatory on the work HARTMANN did to be MDR compliant.

MDR has been on the minds of anyone and everyone in the healthcare sector in Europe for the last several years. HARTMANN did a lot of thinking on it as well, but got down to work, and since 2017 has been implementing its MDR compliance program and achieved MDR-readiness in 2020. As of 26 May 2021, MDR is now fully in play, and HARTMANN can say with confidence that it can supply products with MDR compliance, based on its key notified body TÜV Süd. The company also invested in a robust digital infrastructure and got ahead of the game because of forward-thinking communications with its business partners.

Beginning on May 26, 2022, in vitro diagnostic medical devices to be sold in the European Union must comply with the new In Vitro Diagnostic Medical Devices Regulation (IVDR). Following the implementation of MDR, HARTMANN now shifts focus to handling this next regulation phase.

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).