State of the Art and MDR Compliance: What Manufacturers Must Know

The 26 May 2024 deadline for Medical Device Regulation (MDR) is approaching fast, yet, for many medical device manufacturers there is often still confusion on how and which standards may impact them. One question we frequently hear is “what does “state of the art” standards mean in terms of the EU legislation on medical devices?” In this article, we'll unpack this concept and explain its importance as you prepare to meet MDR requirements. 

Defining “state of the art” for medical devices 

In terms of EU medical device legislation, “state of the art” does not necessarily mean using the very latest technology. Instead, it refers to the current and generally acknowledged best practices in technology and medicine.  

However, it’s important to recognise that it is not a legally defined or binding term. Manufacturers are expected to consider this standard, but compliance with legal requirements is separate and must be explicitly demonstrated. 

Products that are designed and manufactured according to harmonised European standards benefit from a "presumption of conformity." They are presumed to meet regulatory requirements; however, this does not automatically imply compliance with EU legislation unless the standards are published and referenced in the Official Journal of the European Union (OJEU). Manufacturers decide whether to use specific standards, bearing the ultimate responsibility for ensuring their products meet legal requirements when placed on the market. 

To provide further insights and clarity around these standards, the Medical Device Coordination Group published the Guidance on standardisation for medical devices.  

It’s important to note that, while the standards are voluntary, adherence is encouraged. However, manufacturers may also provide suitable justifications for not conforming to the most recent version of the standard. This flexibility acknowledges the diverse circumstances and needs that face the industry. 

Aligning “state of the art” and base standards

When it comes to medical devices, the process of aligning “start of the art” standards to base standards needs a systematic approach to ensure the current practices and technologies are integrated effectively into foundational ones.  

One way to do this is through the addition of annexes or amendments. For medical device standards, Annex Z is particularly crucial as it details how the standard meets the requirements of EU legislation and aligns with the “state of the art”. These annexes can ensure that the base standards adequately reflect the latest developments and compliance needs. 

In addition, alignment should involve extensive consultation with stakeholders, including manufacturers, regulatory authorities, healthcare professionals, and patient groups. This engagement ensures that the standards are practical, meet the industry’s needs, and incorporate the latest innovations and safety measures. 

However, we must also recognise that newer standards often amend or introduce additional requirements beyond those outlined in the base standard. This means it may not be possible to properly align them for a period of time. It’s important to take a pragmatic approach when navigating the landscape of standards. Regulatory compliance requires that products are safe and effective; manufacturers must carefully manage their product development and strategies to ensure they meet these core objectives. 

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