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Registrar Corp
維吉尼亞州漢普頓 (總部), 中國深圳, 英國倫敦, 法國巴黎, 西班牙馬德里, 印度海得拉巴, 馬來西亞吉隆坡, 以色列特拉維夫, 瓜地馬拉瓜地馬拉市, 南非開普敦
000 家企業處理 FDA 註冊、美國代理人要求、標籤合規及扣留協助等事務。我們提供包含 FDA 合規監控器 (Compliance Monitor) 和不良事件管理軟體在內的技術解決方案，協助食品、飲料、醫療器材、藥品和化妝品行業的企業應對複雜的法規環境。
MedEnvoy Global
荷蘭海牙, 英國倫敦, 美國, 瑞士, 澳洲
一家全球法規合規合作夥伴，專注於為醫療器材和 IVD 製造商提供在地代表（EC Rep、UKRP、CH Rep、美國代理人）和獨立進口商服務。我們協助企業應對歐洲、英國、瑞士和美國的複雜法規，同時保持供應鏈的靈活性。
KoBridge Co Ltd
韓國首爾, 瑞士洛桑
我們為需要應對日益複雜的全球法規的醫療器材製造商提供快速、有效和靈活的解決方案。他們的核心能力涵蓋 CE 標誌、FDA 510(k)/PMA、MDSAP，尤其是韓國 MFDS 註冊和 KGMP 合規性。他們處理主動、非主動、組合和動物源性設備，提供從策略規劃和文件準備到品質系統實施 (ISO 13485) 和稽核的服務。
IMed Consultancy Ltd
英國, 愛爾蘭
幫助醫療器械和體外診斷公司進行 CE 標記、品質管理系統、審計和全球註冊。
December 15, 2025
Approximately 5 minutes
Medical Devices: Post-Market Surveillance (PMS) Requirements in the UK
Medical Devices: Post-Market Surveillance (PMS) Requirements in the UK
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Overview of PMS Obligations Post-market surveillance (PMS) is a continuous process used by manufacturers to collect and maintain experience gained from devices already placed on the market. In the UK, manufacturers must implement a PMS system that is proportionate to the risk class and type of the device. This system ensures that any necessary corrective and preventive actions (CAPA) are taken promptly to protect public health. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements
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The Post-Market Surveillance Plan A manufacturer must document their PMS system in a formal Post-Market Surveillance Plan. This plan should outline the methods for collecting and evaluating data, including:
Information on adverse incidents and field safety corrective actions (FSCAs).
Records of non-serious incidents and data on any undesirable side-effects.
Feedback and complaints provided by users, distributors, and importers.
Relevant specialist or technical literature, databases, and registers. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements
- Post-Market Surveillance Report (PMSR) vs. PSUR The documentation requirements vary based on the risk classification of the device:
Class I Devices: Manufacturers must prepare a Post-Market Surveillance Report (PMSR). This report summarizes the conclusions of the PMS data collection and is updated when necessary.
Class IIa, IIb, and III Devices: Manufacturers must prepare a Periodic Safety Update Report (PSUR). The PSUR summarizes the results and conclusions of the PMS data, including the rationale and description of any preventive and corrective actions taken. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements
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Vigilance Reporting and Timelines Manufacturers are legally required to report specific incidents to the MHRA. These include any malfunction or deterioration in the characteristics or performance of a device, as well as any inadequacy in the labeling or instructions for use that might lead to or might have led to the death of a patient or user or a serious deterioration in their state of health. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements
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Retention of Records All PMS documentation and technical files must be kept available for the MHRA for a minimum period (typically 10 to 15 years depending on the device type) after the last device covered by the declaration of conformity has been placed on the market. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements
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