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Connect with regulatory affairs consultancies specializing in this region.
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。
January 15, 2026
Approximately 5 minutes
Implementation of the Future Regulation of Medical Devices in the UK
Implementation of the Future Regulation of Medical Devices in the UK
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Overview and Core Objectives The Medicines and Healthcare products Regulatory Agency (MHRA) is progressing with the implementation of a future regulatory framework for medical devices in the United Kingdom. The core objective is to create a world-leading regime that prioritizes patient safety, fosters innovation, and ensures the UK remains an attractive market for global manufacturers. This new framework will be introduced through several statutory instruments designed to update and strengthen existing requirements. Source: UK Gov Guidance: Implementation of the future regulation of medical devices
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Phased Implementation Timeline To minimize disruption to the industry and healthcare system, the MHRA has adopted a phased approach to implementation. Key milestones include:
Post-market surveillance (PMS): New, strengthened requirements for PMS are expected to be the first major component implemented.
Future Core Regulations: The broader set of core regulations, covering areas such as classification and conformity assessment, is planned to come into effect in 2025. Source: UK Gov Guidance: Implementation of the future regulation of medical devices
- Transitional Arrangements for Existing Devices The government has established transitional arrangements to allow devices that are already on the market to remain there during the shift to the new rules. Generally:
Devices with a valid CE mark or UKCA mark under current rules can continue to be placed on the Great Britain market until their certificates expire or until specific long-stop dates (e.g., 2028 or 2030 depending on the device type).
These arrangements are intended to prevent supply chain gaps and provide legal certainty for manufacturers. Source: UK Gov Guidance: Implementation of the future regulation of medical devices
- Key Areas of Regulatory Change The future regime will introduce significant updates across several pillars:
Classification Rules: Alignment with international standards, particularly for software as a medical device (SaMD) and implantable devices.
In Vitro Diagnostics (IVDs): Enhanced scrutiny and revised risk classifications for IVDs.
International Recognition: Exploring pathways for devices already approved by trusted international regulators to gain market access in the UK more efficiently. Source: UK Gov Guidance: Implementation of the future regulation of medical devices
- Ongoing Stakeholder Engagement The MHRA continues to engage with industry, healthcare professionals, and patient groups to refine the secondary legislation and supporting guidance. Manufacturers are encouraged to stay updated with official government announcements to ensure timely compliance with the upcoming changes. Source: UK Gov Guidance: Implementation of the future regulation of medical devices
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