What, when and how: the regulation news

HARTMANN has the latest in regulations: news, insights and more. Stay up to date.

Follow this site to be up to date on the latest news on regulations in the healthcare sector and for medical products. From press releases to LinkedIn postings to thought leadership papers, HARTMANN keeps you in the know.

MDR and Procurement: HARTMANN ahead of the game

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.

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

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).