Drugdu.com expert's response:

The General Safety and Performance Requirements (GSPR) in the EU Medical Device Regulation (MDR) (2017/745) and In Vitro Diagnostic Regulation (IVDR) (2017/746) constitute the core framework for ensuring the safety and effectiveness of medical devices and in vitro diagnostic medical devices. The GSPR requirements permeate the entire lifecycle of medical devices, encompassing design, manufacturing, clinical evaluation, labeling, and post-market surveillance. The specific content is as follows:

I. Chapter Division of GSPR

The GSPR requirements are detailed in Annex I of the MDR and IVDR and are divided into three chapters:

Chapter 1: General Requirements for Risk-Based Management

Medical devices must operate in accordance with their intended design and must not endanger the health or safety of patients, users, or third parties.

Risks must be minimized as much as possible, and the degree of reduction must not negatively impact the risk-benefit ratio.

Manufacturers are required to establish, implement, and maintain a risk management system that is continuously updated throughout the device's entire lifecycle.

If risks cannot be completely eliminated, manufacturers must take all necessary measures to protect users and provide clear and understandable information about the remaining risks.

The design, manufacturing, and packaging of devices must ensure that they are not damaged during transportation and storage and can withstand stress under normal conditions of use.

Chapter 2: Requirements for Performance, Design, and Manufacturing

Devices must meet their intended basic performance characteristics, such as accuracy, reliability, and durability.

Manufacturers must ensure that the design and manufacturing processes of devices comply with relevant regulations and standards to guarantee product quality and reliability.

For materials that may come into contact with the human body, biocompatibility testing must be conducted to ensure that they do not cause allergic reactions, irritation, or toxicity.

Manufacturers must consider the compatibility between different components of the device, as well as risks that may arise from the interaction between the device and its environment (e.g., radiation, humidity, temperature).

For sterile devices, appropriate methods must be used for manufacturing and sterilization, and a sterile control system must be established.

Chapter 3: Requirements for Labeling and Instructions for Use (IFU)

Each device must be accompanied by information necessary for identifying the device and its manufacturer, as well as all safety and performance information relevant to users or others.

Labels must include the intended use of the device, performance characteristics, all risk information related to its use, and the Unique Device Identification (UDI).

Instructions for use must be detailed and easy to understand, guiding users on the correct use of the product and informing them of potential risks and precautions.

For packaging that maintains the sterility of the device, clear instructions and labeling must be provided.

II. Core Requirements of GSPR

Risk Management

Manufacturers must identify and assess all known and foreseeable risks associated with the device and take measures to reduce or eliminate these risks.

The risk management process must follow the EN ISO 14971:2019 standard and be regularly updated to reflect production and post-production information.

Residual risks must be controlled within acceptable limits and clearly communicated in user information (e.g., instructions for use, labels).

Clinical Evaluation

Manufacturers must conduct a clinical evaluation to demonstrate the safety and performance of the device under normal conditions of use.

The evaluation should be based on clinical data and consider clinical techniques, as well as the risks and benefits associated with the device.

For high-risk devices, clinical trials may be required to further assess their safety and efficacy.

Quality Management System

Manufacturers must establish and implement a quality management system (e.g., ISO 13485) to ensure the consistency and stability of device manufacturing.

The quality management system should cover the entire process from raw material procurement, production processing, product inspection, to packaging and transportation, and include quality planning, quality control, quality assurance, and quality improvement.

Post-Market Surveillance and Vigilance

Manufacturers must establish a post-market surveillance system to monitor the safety and performance of the device.

All adverse events or incidents must be reported to regulatory authorities, and appropriate corrective actions must be taken.

Technical documentation must be regularly updated to reflect the results of post-market surveillance.

III. Universality and Impact of GSPR

The GSPR are not only requirements set by the EU for medical devices but also applicable to many other countries, such as China, Australia, Brazil, and member states of the Association of Southeast Asian Nations (ASEAN). These countries may rename or partially adopt the GSPR after modification.

Compliance with the GSPR is a critical factor for the successful entry of medical devices into the EU market and a mandatory compliance requirement for manufacturers before placing medical devices on the EU market.