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标签：#Medical Devices

1月9日，英国药品和医疗保健产品监管局（MHRA）宣布了其医疗器械监管计划。新法规的“路线图”规定了通过一系列新的法定文书（SI）实施新法规的途径。该机构今年将实施保护患者安全的优先措施，新框架的核心要素计划在2025年前到位。（图附于文末）

On January 9, The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced its plan for medical device regulation.The ‘roadmap’ for new regulationssets out a route to deliver new regulations via a series of new Statutory Instruments (SIs). The agency will put priority measures to protect patient safety into place this year, with core elements of the new framework intended to be in place by 2025.

该机构在公告中表示，新规定将“把患者安全放在首位，有助于确保患者继续毫不拖延地获得他们需要的设备，同时提高英国作为世界领先的医疗技术创新者环境的地位。”

In itsannouncement, the agency stated that the new regulations will “put patient safety first and help to ensure that patients continue to have access without delay to the devices they need, while enhancing the UK’s position as a world-leading environment for medical technology innovators.”

除了为新的植入式设备、医疗保健人工智能和软件以及疾病早期检测和预防诊断等变革性技术创建一个新的监管框架外，计划中的法规还旨在实现更大的国际协调，对响应技术进步的医疗设备提出了更多以患者为中心的要求。

In addition to creating a new regulatory framework for transformative technologies such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease, the planned regulations are also designed to deliver greater international harmonization, with more patient-centered requirements for medical devices which are responsive to technological advances.

Laura Squire博士说：“今天令人兴奋的医疗技术进步为患者护理和医疗保健提供了重要的新机会。因此，我们很高兴在新的一年开始时制定一项全面的计划，在未来两年内大幅改进医疗器械的监管框架。”，MHRA医疗技术监管改革负责人兼首席医疗保健、质量和准入官。“新框架将加强MHRA保护患者安全的能力，同时有助于创造一个鼓励推出对公众健康产生真正影响的最具创新性的医疗保健产品的环境。路线图规定了随着这一进程的推进，我们将如何与包括患者在内的利益相关者合作，尽早了解来给我们反馈他们将需要的指导，以确保这些广泛的英国改革的成功实施。”

“Today’s exciting medical technology advances offer important new opportunities for patient care and improvements to healthcare delivery.We are therefore delighted to begin this new year by setting out a comprehensive plan for significant improvements to the regulatory framework for medical devices over the next two years,” said Dr. Laura Squire, Med Tech Regulatory Reform Lead and Chief Officer Healthcare, Quality and Access at MHRA.

“The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health. The roadmap sets out how we will work with stakeholders, including patients, as the process moves forward, giving early sight of what is to come and giving us feedback about the guidance they will need to ensure the successful implementation of these wide-ranging UK reforms.”

英国政府打算在2024年出台立法，在更广泛的未来监管框架之前，在英国实施强化的上市后监督要求（PMS）。这些规定将以世界贸易组织的上市后监督要求法定文书草案（PMS SI）和收到的有关要求草案的反馈为基础。新的PMS要求预计将于2024年上半年公布，并于2024年底生效。

The UK government intends to introduce legislation in 2024 that will bring into force strengthenedPost-Market Surveillance requirements (PMS)in Great Britain (GB)ahead of the wider future regulatory framework. The regulations will be based on the World Trade Organisation’sdraft Post-market Surveillance Requirements Statutory Instrument(PMS SI) and feedback received on the draft requirements. The new PMS requirements are expected to be announced in the first part of 2024 and come into force towards the end of 2024.

在2024年上半年，MHRA计划就未来的核心法规举行利益相关者讨论，这些法规将：

During the first half of 2024, MHRA plans to hold stakeholder discussions on future core regulations that will:

介绍植入式医疗器械的几项改进；对其进行分类，这将导致更严格的上市前和上市后要求，并要求制造商提供植入卡，使患者能够知道他们植入了哪种设备。

Introduce several improvements for implantable medical devices; up-classifying them which will result in more stringent pre and post market requirements and requiring manufacturers to provide implant cards to enable patients to know which device they have had implanted.

确保设备具有唯一的设备标识符（UDI）。

Ensure devices have a unique device identifier (UDI).

改变几种类型设备的分类，特别是增加某些软件作为医疗设备的类别，并将IVD分类与国际医疗设备监管机构论坛的分类保持一致。

Change the classification of several types of devices, specifically increasing the class of certain software as a medical device and aligning IVD classifications with those of the International Medical Device Regulators Forum.

加强对质量管理体系和技术文件的要求。

Strengthen the requirements for quality management systems and technical documentation.

引入一个国际认可框架，使已经获得类似监管机构批准的设备以及拥有医疗设备单一审计计划（MDSAP）证书的设备能够更快地访问。

Introduce a framework for international recognition, enabling swifter access for devices already approved by comparable regulators as well as for those who have Medical Device Single Audit Program (MDSAP) certificates.

包括豁免内部制造设备和定制设备的新要求。

Include new requirements for exempt in-house manufactured devices and custom-made devices.

包括制造商可以对其医疗器械提出的索赔的新要求，要求其符合其预期用途声明。

Include new requirements for the claims manufacturers can make about their medical devices requiring them to align with their statement of intended purpose.

包括临床调查的新要求。

Include new requirements for clinical investigations.

使英国市场上医疗器械的基本要求与欧盟的基本要求更加一致。这将包括对作为医疗设备的软件（包括人工智能）的网络安全要求。

Bring the essential requirements for medical devices being placed on the market in GB into greater alignment with those of the EU. This will include cybersecurity requirements for software as a medical device including for artificial intelligence.

明确合格评定和批准机构的要求。

Clarify the requirements for conformity assessments and approved bodies.

明确对经济经营者的要求；制造商、进口商和分销商，并引入了具有合规资格人员的要求。

Clarify the requirements for economic operators; manufacturers, importers and distributors, and introduce a requirement to have a Person Qualified in Regulatory Compliance.

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