Class III Medical Devices

The definition and compliance requirements for Class III medical devices are more stringent than for all other classes, particularly with respect to demonstrating device quality, safety, and performance during the conformity assessment procedures required for placing them on the EU market. Some crucial information for manufacturers seeking to understand and comply with the regulatory framework for high-risk medical devices in Europe is provided below.

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:

• Long term and short term Implantable devices

• Prosthetic valves (Heart)

• Active stimulators

• Bone replacements

Under the EU MDR 2017/745, manufacturers of Class III medical devices must meet several strict regulatory requirements. These requirements focus on clearly demonstrating the safety and performance of high-risk devices for both patients and regulatory authorities. The key requirements include the following:

• Technical Documentation: Manufacturers must prepare detailed technical documentation file for their Class III devices. This file must contain adequate information to 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 and detailed clinical evaluation is mandatory for Class III devices. Manufacturers must do literature search or conduct clinical investigations to gather sufficient clinical evidence to demonstrate the safety and performance of their devices in line with the intended purpose. The clinical evaluation must be based on an evaluation of relevant scientific literature, clinical experience, and clinical investigation results.

• Quality Management System (QMS): Manufacturers must establish and maintain a robust medical device quality management system (MDQMS) 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 and IVD,s. Manufacturers must assign a UDI barcode to their all scalable units of Class III devices and submit the UDI information to the 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. ( Post CE Certification)

• 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