The European Union’s Medical Device Regulation (EU MDR 2017/745) has introduced a comprehensive and detailed framework for the classification of medical devices. This classification system is crucial for legal manufacturers as it determines the level of regulatory control over the device, affecting both pre-market and post-market requirements. Understanding this classification system is therefore essential for manufacturers to ensure compliance and successful market access.
The EU MDR 2017/745 classifies medical devices into four main categories based on their risk level:
These are low-risk devices. Examples include non-invasive devices, reusable surgical instruments, and devices that have a short-term contact with the skin. Within Class I, there are also subclasses which include Class Is (sterile), Im (measuring), and Ir (reusable surgical). For these subclasses, the aspects related to sterility, measuring function, or reusability must be assessed by a Notified Body.
These are low-to-medium risk devices. Examples include devices that are used for diagnosis or monitoring, and devices that are invasive in body orifices.
These are medium-to-high risk devices. Examples include long-term corrective contact lenses, surgical meshes, and devices that administer medicinal products.
These are high-risk devices. Examples include implantable devices and life-supporting or life-sustaining devices.
The classification of a medical device is governed by MDR Article 51 and Annex VIII of the MDR EU 2017/745. The classification rules consider various factors such as the intended purpose of the device, its invasiveness, and its duration of contact with the body.
The classification of a medical device is not just a bureaucratic exercise. It plays a significant role in determining the conformity assessment route that the device must follow. Higher-risk devices are subject to more stringent regulatory controls, including the need for a Notified Body’s involvement in the conformity assessment process.
Moreover, the classification of a device also affects its post-market surveillance requirements. Higher-risk devices are subject to more rigorous post-market clinical follow-up and vigilance reporting requirements. For example, the Unique Device Identification (UDI) labeling applies to all devices and will be required for Class I devices from 26 May 2025, and for Class Ir devices from 26 May 2027.
For manufacturers seeking assistance with the classification process, Regulatory Globe offers a comprehensive classification template. This template includes the complete Annex VIII (classification rules) of MDR EU 2017/745 and provides a structured approach to classify your devices.
The template is designed to be user-friendly, allowing manufacturers to just download and start the classification process. It is available in English and is compatible with Word 2010, Word 2013, and Word 2016.
Understanding and correctly applying the EU MDR 2017/745 classification system is crucial for medical device manufacturers. It is a key step in ensuring regulatory compliance and achieving successful market access. Tools like the classification template from Regulatory Globe GmbH can provide valuable assistance in this complex process.
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