Exploring the Ambiguities of MDR: Understanding "State-of-the-Art" in Medical Device Regulation
Introduction
The term “state-of-the-art” is frequently used in the context of the European Union’s Medical Device Regulation (MDR), which came into effect in May 2022. Despite its frequent appearance, the term remains undefined in the MDR, leaving medical device manufacturers and notified bodies in a state of uncertainty. This article aims to shed light on the complexities surrounding the term “state-of-the-art” within MDR, focusing on standards harmonization, risk management, and clinical data.
What Does "State-of-the-Art" Mean?
The Oxford Dictionary describes “state-of-the-art” as the most recent stage of technological development, incorporating the latest technology, ideas, and features. However, the Medical Device Coordination Group (MDCG) refers to the International Medical Device Regulators Forum for a more industry-specific definition. According to the forum, “state-of-the-art” medical devices are those at a “developed stage of current technical capability and/or accepted clinical practice.”
Harmonized Standards: The Cornerstone of "State-of-the-Art"
Harmonized standards are developed by recognized European standards organizations like CEN, CENELEC, or ETSI. These standards serve as a quick reference point for manufacturers and notified bodies to demonstrate compliance with EU legislation. However, the MDR provides limited guidance when non-harmonized standards are involved. Manufacturers can refer to international and European consensus standards from ISO, IEC, or EN as these often serve as the basis for MDR harmonized standards.
Risk Management: Balancing Safety and Performance
MDR Article 10 outlines the need for a comprehensive product safety risk management system. The requirements include risk reduction, implementation of a risk management system for each device, and state-of-the-art risk control measures. The focus on advanced chemical analyses, as outlined by ISO 10993-1:2018 and ISO 10993-18:2020, has shifted the landscape, emphasizing the need for more rigorous chemical characterization data.
Clinical Data: The Bedrock of Equivalence Claims
The MDR emphasizes the importance of clinical data, especially for implantable and class III devices. When equivalence cannot be demonstrated, the MDR outlines alternative purposes for using data from “similar” devices. These include identifying relevant hazards, defining the scope of clinical evaluation, and providing input for clinical investigation design. Collaboration between clinical and preclinical experts is essential for managing risk and ensuring that only state-of-the-art products are available.
Conclusion
The term “state-of-the-art” in the context of MDR is dynamic and subject to interpretation. Notified bodies play a significant role in defining what constitutes state-of-the-art, based on their understanding of MDR and EU regulatory law. Manufacturers aiming for EU market access should closely monitor the regulatory landscape and consider collaborating with experienced partners for assessing standards, risk, and clinical data.
By understanding the intricacies of “state-of-the-art” within the MDR framework, manufacturers can better navigate the complexities of regulatory compliance, thereby ensuring that their products meet the highest standards of safety and effectiveness.