One topic that’s getting a lot of attention in the industry these days is Medical Device Regulation (MDR). With all the buzz around the subject, we thought it’d helpful to address some of the most common questions regarding MDR and our role in guideline adherence.
Medical Device Regulation is the latest European Union (EU) regulation that sets the framework for medical devices on the market, including quality management and post-market surveillance.
MDR replaces the previous regulation known as the Medical Device Directive (MDD).1 MDR was developed to meet the need for a more robust, transparent, predictable, and sustainable regulatory framework to ensure safe, effective, and high-quality medical devices for the health and safety of patients and users.1
MDR is the regulatory framework for the EU. All medical device manufacturers and suppliers in this region must comply with MDR requirements or they will lose access to the EU market.
MDR compliance is required for the EU market, but not for other regions. Despite this, Medtronic has decided to roll out compliance globally because we foresee that MDR standards will affect global standards.
Further, we believe it’s important to have a harmonized international standard for all of our medical devices.
We also believe that having multiple versions of the same product could complicate our supply and inventory processes.
Medtronic has updated our airway management portfolio to ensure MDR compliance. The thoughtfully curated portfolio includes several trusted brands in one family, providing the options needed to deliver individualized care.
The airway management portfolio includes:
Specifically, we have updated our products in the following three ways to align with MDR:
MDR was initiated in April 2017 and became fully applicable in May 2021. The timeline for the transition from MDD to MDR was postponed due to the COVID-19 pandemic.
As of May 2021, new medical devices cannot be introduced to the EU market if they do not meet MDR requirements.
To prevent shortages, a regulation was published in May 2023 that extended the transition period for legacy devices — defined as those certified under MDD — until December 2027 or 2028, depending on the risk class of the device.2
Medtronic has been proactively updating our products and is on track to meet the MDR timeline. Because of these preemptive efforts, we are confident that our customers’ supply chain will not be impacted as we make the transition from MDD to MDR products as seamless as possible.
At Medtronic, product quality is always a priority. That’s why we’ve taken the initiative to modernize our airway management portfolio, creating state-of-the-art products to help healthcare professionals and their patients breathe easier. Because patient safety is non-negotiable. And because every breath matters.
References
1. Huusko J, Kinnunen UM, Saranto K. Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals. BMC Health Services Research. 2023;23(1). doi: https://doi.org/10.1186/s12913-023-09316-8.
2. Tarranco D. EU MDR: Definition, Timelines, Requirements, and Compliance. SimplerQMS. Published May 14, 2025. https://simplerqms.com/eu-mdr/.
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