Draft UK Post-market Surveillance Requirements
We have some exciting news to share regarding the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has recently published its draft Statutory Instrument on The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 on the World Trade Organization (WTO) website. This draft regulation is expected to bring significant changes to the post-market surveillance of medical devices, aiming to enhance public health and safety.
Proposed Date of Adoption: December 2023
Proposed Date of Entry into Force: June 2024
The Secretary of State, in accordance with the Medicines and Medical Devices Act 2021, is responsible for these regulations. A public consultation has been carried out, and after considering the matters specified in the Act, it is believed that the benefits of these Regulations outweigh the risks, especially concerning the safety of medical devices.
Post-market Surveillance System
One of the major highlights of the draft regulation is the introduction of a robust post-market surveillance system for medical devices. This system will be implemented by manufacturers for each device placed on the market or put into service. Here are some key aspects of the proposed post-market surveillance system:
Proportionate to Risk: The system must be proportionate to the risk posed by the device. This ensures that higher-risk devices receive appropriate attention and monitoring.
Device Appropriateness: The system's approach should be appropriate for the specific type of device, considering its complexity and potential impact on patients.
Data Analysis: Manufacturers must conduct a comprehensive analysis of relevant data throughout the device's lifespan, focusing on its quality, performance, and safety. The conclusions drawn from this analysis should be recorded.
Continuous Monitoring: The post-market surveillance system must be utilized throughout the entire post-market surveillance period. It should identify preventive actions, corrective actions (including field safety corrective actions), trends in incidents, and opportunities to enhance the device's usability, performance, and safety.
Data Utilization: Data gathered through the post-market surveillance system will play a vital role in updating various aspects of the medical devices, including instructions for use, labeling, design and manufacturing information, risk analysis, and evaluation of clinical data, as required for confirming conformity with essential requirements.
Different Device Categories: The regulations specify different requirements for devices placed on the market or put into service under different Parts (Part 2, 3, or 4) of the regulation.
Ensuring Safety and Efficiency:
The implementation of a robust post-market surveillance system will greatly contribute to safeguarding public health. By continuously monitoring medical devices and promptly addressing any potential issues, the MHRA aims to ensure that devices remain safe and effective throughout their use.
Before the regulation can be formally adopted and come into force, it will go through parliamentary procedures, including scrutiny and approval by both Houses of Parliament. During this process, the regulation may be subject to further revisions based on feedback and recommendations.
As we eagerly await the final adoption of these regulations, it is essential for manufacturers, healthcare professionals, and stakeholders to stay informed and prepared for the changes ahead. The proposed post-market surveillance requirements demonstrate the UK MHRA's commitment to strengthening the oversight of medical devices and upholding the highest standards of patient safety.
If you are a UK-non based medical device manufacturer understanding and complying with the upcoming post-market surveillance regulations is crucial for ensuring your products' safety and compliance. Navigating through the intricacies of these new requirements may seem challenging, but fear not – AF Pharma is here to assist you. As a leading regulatory consulting firm specializing in medical devices, AF Pharma has a team of experienced professionals well-versed in the latest MHRA regulations. We can guide you through the necessary steps to establish a comprehensive post-market surveillance system tailored to your device's specific risk profile. With AF Pharma's expertise and support, you can confidently navigate these regulatory changes, ensuring your devices meet the highest safety and performance standards, and ultimately, contribute to better patient outcomes. Don't hesitate to reach out to AF Pharma today to take the first step towards compliance and excellence in the evolving UK medical devices landscape.
Please find below the UK Draft Post-market Surveillance Requirements.