Class III Medical Devices

This page provides an overview of Class III medical devices under the European Union Medical Device Regulation (EU MDR) 2017/745. It outlines the definition of Class III devices, the stringent requirements they face, and the conformity assessment procedures necessary for placing them on the EU market. This information is crucial for manufacturers seeking to understand and comply with the regulatory landscape for high-risk medical devices in Europe.

Class III medical devices are the highest risk category of medical devices under the EU MDR 2017/745. These devices pose the greatest potential risk to the patient and/or user. They typically sustain or support life, are implanted in the body, or control critical bodily functions. Due to their high-risk nature, Class III devices are subject to the most rigorous regulatory scrutiny. A few examples of Class III medical devices include:

• Implantable devices (e.g., pacemakers, defibrillators, hip replacements, breast implants)

• Heart valves

• Stents

• Neural stimulators

• Total joint replacements

The EU MDR imposes several stringent requirements on manufacturers of Class III medical devices. These requirements are designed to ensure the safety and performance of these high-risk devices. Some of the key requirements include:

• Technical Documentation: Manufacturers must prepare comprehensive technical documentation for their Class III devices. This documentation must demonstrate that the device meets the relevant General Safety and Performance Requirements (GSPRs) outlined in Annex I of the EU MDR.

• Clinical Evaluation: A thorough clinical evaluation is essential for Class III devices. Manufacturers must conduct clinical investigations to gather sufficient clinical evidence to demonstrate the safety and performance of their devices for their intended purpose. The clinical evaluation must be based on a critical evaluation of relevant scientific literature, clinical experience, and clinical investigation results.

• Quality Management System (QMS): Manufacturers must establish and maintain a robust QMS that complies with the requirements of ISO 13485. The QMS should cover all aspects of the device lifecycle, from design and development to manufacturing, distribution, and post-market surveillance.

• Unique Device Identification (UDI): The EU MDR mandates the use of a UDI system for medical devices. Manufacturers must assign a UDI to their Class III devices and submit the UDI information to the European Database on Medical Devices (EUDAMED). The UDI system facilitates traceability and post-market surveillance.

• Post-Market Surveillance (PMS): Manufacturers are required to implement a comprehensive PMS system to actively monitor the performance of their devices after they are placed on the market.

• Person Responsible for Regulatory Compliance (PRRC): Manufacturers must designate a PRRC who is responsible for ensuring that the device complies with the requirements of the EU MDR.

Class III devices are subject to a rigorous conformity assessment procedure that involves a Notified Body. The Notified Body is an independent organization designated by a Member State to assess the conformity of medical devices with the requirements of the EU MDR. The conformity assessment procedure for Class III devices typically involves the following steps as shown in the below image