The European Union’s Medical Device Regulation (MDR 2017/745), which became applicable on May 26, 2021, represents a significant overhaul of the EU’s regulatory framework for medical devices.
Developed to reflect advancements in medical device technology and to ensure a higher standard of safety and performance, the MDR replaces the earlier Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. As manufacturers work to meet the stringent requirements of the MDR, understanding its key components and compliance pathways is essential for continued access to the European market.
The MDR introduces several critical changes compared to the previous directives, focusing on patient safety, transparency, and traceability. Some of the most impactful changes include:
To achieve MDR compliance, manufacturers must undergo a conformity assessment conducted by a Notified Body, depending on the classification of their devices. The process generally involves:
The MDR officially came into force on May 26, 2021, with a transition period extended until December 31, 2028, for devices previously approved under the MDD and AIMDD. This extension allows manufacturers additional time to achieve MDR certification, particularly for devices already on the market. However, despite the extended deadlines, manufacturers are strongly encouraged to begin the certification process as early as possible to avoid market access disruptions.
Given the complexity of the MDR and the potential for longer processing times, early action is crucial. TÜV SÜD, as one of the first organizations designated as a Notified Body under the MDR, advises manufacturers to start their compliance journey now. Engaging with a Notified Body early can help identify potential challenges and streamline the certification process, ensuring that devices remain on the market without interruption.
The MDR 2017/745 is a comprehensive regulation designed to ensure the safety and efficacy of medical devices in the EU market. While the transition to the new requirements can be challenging, proactive planning and engagement with Notified Bodies like TÜV SÜD can help manufacturers navigate the complexities of compliance. By understanding the key changes and starting the certification process early, manufacturers can continue to provide safe, innovative medical devices to the European market.
For streamlined supplier management in compliance with MDR requirements, Relatico’s SRM software offers comprehensive tools to manage supplier relationships and ensure regulatory compliance. Contact Relatico today to learn how our solutions can support your MDR compliance efforts.
Bernd possesses extensive experience in strategic procurement, shaped by his tenure at Eckes-Granini, Symrise and DuPont de Nemours. Currently, he is focused on sustainable sourcing and supply chains, collaborating with the relatico team to develop practical software solutions. Additionally, Bernd runs his own agricultural business and is involved in supply chain projects globally.