MDR & Procurement

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.

Of course, implementing MDR raised not only budgetary concerns but also procedural challenges. HARTMANN decided to invest time and money in a communication and training campaign towards its supply base. All medical suppliers – whether of raw materials, semi-finished goods and finished goods – had to adopt to the MDR. Rather than wait for them to figure it out on their own, the company took a proactive and a very hands-on approach.

In the first half of 2019, HARTMANN conducted workshops on three different continents for over 420 companies in order to help suppliers and service partners to prepare for the new regulations. Already in 2018, all medical suppliers were contacted directly to follow up on their level of understanding and knowledge of MDR and to find out what more could be done. More than 85% of those contacted suppliers were finally participating on those workshops to fine-tune and deepen their expertise. Finally, a call center and hotline number were set up so suppliers could always get in touch with follow-up questions.

Even in the best of circumstances, organizing multiple partners across various supply chains requires finesse. Managing the complex and diverse demands that comes with overseeing MDR conformity with hundreds of suppliers requires twice the finesse – just think alone of the MDR related documentation! This is where an early enough commitment to digitalization really paid off.

HARTMANN implemented SAP Ariba – a procurement and supply chain solution – to enable a higher level of efficiency for all internal and external communications. Using the software changes the way the company works with suppliers and also helps the entire supplier network fully enter the digital age. The software not only streamlines communications, it also hugely simplifies managing all the documents and contracts, as well as enables a fully automated onboarding of suppliers. All contracts can be easily adapted to the MDR regulations – allowing for the diverse demands that different suppliers face, depending on whether they supply raw materials or finished products. Even the smallest changes that need to be documented are done automatically, allowing for an excellent overview of the MDR compliance status and freeing up employees to concentrate on other tasks. The company has now closed the door on diverse, local systems, and has full transparency across all suppliers.

As of today, most of HARTMANN’s risk class 1 non-sterile medical products are MDR-certified and out in the market. MDR compliance for other risk classes is on track and will be finalized in 2022. The company will also continue to work closely with its supply base and service partners to ensure an uninterrupted line of supplies. This experience with MDR paves the way for the next regulations in the health sector – such as IVDR and BPR – and HARTMANN looks forward to finding new ways again with partners to make safety, excellence, and reliable supply lines available to everyone in the health sector community.