What is the EU Medical Device Regulation (MDR 2017/745): What Manufacturers Need to Know

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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.

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Key Changes Under MDR 2017/745

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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:

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1. Expanded Scope and Classification Rules: The MDR broadens the definition of medical devices, now including products without a medical purpose, such as cosmetic implants and contact lenses. The regulation also revises classification rules, potentially upgrading the risk classification of many devices, which necessitates stricter conformity assessments.
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2. Stringent Clinical Evaluation Requirements: Clinical evidence must now be robust and reflect real-world use, with stricter requirements for clinical evaluations, particularly for higher-risk devices. Manufacturers must also maintain ongoing post-market clinical follow-up (PMCF) to monitor device performance and safety.
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3. Unique Device Identification (UDI) System: The MDR mandates a Unique Device Identification (UDI) system to enhance traceability across the supply chain. Each device will have a unique identifier, which will be recorded in the EUDAMED (European Database on Medical Devices), facilitating the tracking of devices throughout their lifecycle.
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4. Transparency Through EUDAMED: The MDR emphasizes transparency, requiring detailed information on devices to be available through the EUDAMED database. This includes data on clinical investigations, vigilance reports, and device traceability, accessible to both regulators and the public.
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5. Enhanced Vigilance and Post-Market Surveillance: The regulation requires a more proactive approach to post-market surveillance (PMS), with manufacturers needing to implement systems to continuously monitor device performance and report any incidents or corrective actions.

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The MDR Compliance Process

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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:

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1. Conformity Assessment Application: Manufacturers must submit an application to a Notified Body, which will review the device’s technical documentation, risk classification, and clinical evidence. This step is critical for ensuring the device meets MDR requirements.
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2. Clinical Evaluation and PMS: A thorough clinical evaluation is mandatory, with ongoing PMS activities required to gather real-world data. The results of these evaluations must be documented and submitted as part of the conformity assessment.
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3. Structured Dialogue: Before lodging a formal MDR application, manufacturers can engage in a structured dialogue with a Notified Body to clarify procedural and regulatory aspects, helping to streamline the submission process.
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4. Labeling and UDI Compliance: Devices must be correctly labeled according to MDR guidelines, including the assignment of a UDI. This ensures proper identification and traceability across the EU market.
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5. EUDAMED Registration: Manufacturers must register their devices in the EUDAMED database, providing detailed information on the device, its clinical evaluation, and post-market surveillance activities.

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Timeline and Transition Periods

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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.

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Importance of Early Action

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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.

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Conclusion

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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.

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Relatico

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.

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