Wow! How quickly six years can go by. In 2017, we began the implementation of the Medical Device Regulation (MDR) in our QMS and subsequently in our regulatory systems. Today, six years later, HARTMANN has fully converted all quality and regulatory systems to the MDR.
It was a terrific team effort. Our customers can now rely on an MDR-compliant HARTMANN portfolio that can be delivered reliably and without interruptions – including new and significantly changed products.
From the beginning, it was important to us to implement the MDR as quickly as possible and to relieve our customers of any worries about delivery bottlenecks. A big advantage was that we already had TÜV Süd as a notified body, which was also accredited according to the MDR relatively early on.
In our company history, the MDR implementation is probably one of the largest regulatory and quality projects. The current success saves us a lot of effort compared to the Medical Device Directive, which has been in place since the 1990s.In total, several hundred employees were involved. But this team effort was worth it: We are proud that HARTMANN is one of the first companies to be MDR-compliant.
Inventories built up in a targeted manner
During the changeover process, HARTMANN selectively built up stocks of MDR-compliant products. In this way, the supply of MDR-approved products remained and was ensured at all times. We can already enter into long-term cooperations and contracts with customers and suppliers without any restrictions. This is particularly important with regard to long-running tenders, as the MDR deadline extensions currently adopted can still lead to uncertainties. As an MDR-compliant supplier, we now face no hindrances in offering our customers the entire HARTMANN portfolio and entering into long-term agreements.
Tailwind for innovations
Companies that are fully MDR-compliant can bring innovations and product adaptations to market more easily because they do not have to comply with the concurrent Medical Device Directive (MDD) like other suppliers. Our employees can now focus more on new products and product enhancements instead of complying with parallel regulations.
The changeover phase was a tour de force for HARTMANN – one which required enormous capacities and resources over the past few years. But we have managed it with an outstanding team performance. I would like to thank the many colleagues who contributed to the success of this ambitious project!
