Clinical investigations for medical devices
正文 · 中文译文
指南 医疗器械临床研究 如何向MHRA通报您开展医疗器械临床研究的意向。 来源： 药品和健康产品管理局 发布日期： 2014年12月18日 最后更新： 2026年11月6日 — 查看所有更新 订阅本页邮件通知 打印本页 目录 我的研究是否需要临床研究申请？ 联系我们 费用 临床研究付费 中小企业付费减免 微型和小型企业医疗器械临床研究费用豁免计划 开始您的申请 评估 研究用药品和医疗器械的申请——并行审评 修订 报告要求 北爱尔兰 医疗器械：北爱尔兰的临床研究和性能研究 健康研究管理局（HRA）和威尔士健康与照护研究（HCRW）批准 更多信息 作为获得医疗器械UKCA、CE或CE UKNI标志流程的一部分，您可能需要开展临床研究。如果您计划开展此项研究，必须在研究开始前至少60天通知MHRA。 我的研究是否需要临床研究申请？ 对于在英国开展的研究，请使用本流程图及随附指南，以确定您是否需要向MHRA提交申请。2025年8月，MHRA发布了这些文件的更新版本。请查阅最新的可用指南，并确保您了解其自该日期起对临床研究申请的相关内容。 对于在北爱尔兰或大不列颠及北爱尔兰开展的研究，请使用北爱尔兰部分的流程图及随附指南。 注：对于已获得UKCA、CE或CE UKNI标志且用于所研究目的的医疗器械，无需向MHRA提交通知。 根据《医疗器械条例》(EU) 2017/745（MDR）附件XVI，无预期医疗用途的器械申请在英国（GB）不被接受。 医疗机构的特殊情况 以下情况下，您无需就临床研究通知我们： 您为自身患者在本机构内制造了该医疗器械，且无将其投放市场的目的 以下情况下，您可能需要就临床研究通知MHRA： 您希望向另一机构提供一种医疗器械，该器械迄今为止一直为患者在本机构内制造，用于提供数据以支持商业产品的安全性和性能 阅读更多关于普通医疗器械的卫生机构豁免的内容，以了解豁免是否适用于您的研究。 请参阅流程图及随附指南，以帮助确定您是否需要向MHRA提交申请。 联系我们 临床研究咨询 有关临床研究申请的具体咨询，请联系 info@mhra.gov.uk，并确保在邮件主题中注明“临床研究咨询”。 监管建议会议 MHRA临床研究团队可提供全面的器械监管建议会议。 我们无法审阅个别文件，但可以就如何应对监管环境提供指导。 有关监管建议会议收费的信息，请参阅我们的费用信息。 如需申请监管建议会议，请联系临床研究负责人 mark.grumbridge@mhra.gov.uk。 费用 请参阅我们费用页面的第7节。 根据《2002年医疗器械条例》规定的费用： (a) 应在向其相关通知提交给国务大臣时支付； 以及 (b) 应在提交该通知时随附。 我们费用页面上详列的费用也涵盖北爱尔兰的器械研究申请。 临床研究付款 如何向MHRA付款。 我们将为付款创建发票，为协助我们开具发票，请确保尽快向我们提供采购订单号，并确认由谁负责付款。 一旦您收到发票并完成付款，您应通过电子邮件将付款凭证发送至 CI-applications@mhra.gov.uk 及您指定的监管事务专员，并注明MHRA参考号（CI/XXXX/XXX）。 在我们收到付款之前，我们不会对该申请提供最终监管决定（批准或反对函）。 中小企业的费用减免 中小企业可申请临床研究费用减免。在提交申请时，您必须提供MHRA的中小企业批准函，以便费用减免得到考虑。 MHRA在收到申请验证后，将要求支付50%的费用，剩余50%将在首张发票开具后六个月内支付。 如果未支付剩余的50%未结费用，则MHRA提供的任何临床研究批准函将被撤销，导致该临床研究停止。 如申请被异议或撤回，剩余费用仍需支付。 器械法规咨询会议不提供任何减免。 更多信息，请参见中小公司费用减免与豁免。 微型和小型企业医疗器械临床研究费用豁免计划 面向拟使用创新医疗器械开展临床研究的微型和小型企业的费用豁免计划 MHRA将其费用豁免计划延长至2026-2027年，自2026年4月20日开始。 符合条件的英国小型和微型企业总共可获得十项临床研究申请费用豁免。 该计划旨在通过测试取消小型企业监管费用（费用可能成为增长或创新的障碍）的影响，支持患者获得创新器械。 费用豁免计划详情 持续时间：该计划将从2026年4月20日持续至2027年4月5日，或直至所有费用豁免均已授予为止。 可用豁免：总共将提供十项费用豁免，适用于I类、IIa类、IIb类，现在还包括III类，但不包括有源植入式器械。 效果：成功申请者将完全免除通常的临床研究申请费用。 注意： 每位申请者只能批准一项豁免 我们将接受涉及CTIMP的研究申请，但费用豁免仅针对申请中的器械方面，CTIMP审查的完整费用仍需支付 豁免资格条件 要符合资格，必须满足以下条件： 申请者能够证明该器械符合“创新器械”的以下标准： 该产品要么是新产品，要么是现有技术的新颖改良； 在英国没有满足相同临床需求且已获得监管批准的解决方案；以及 该器械能够扩大规模，最终目标是惠及健康与社会照护系统、患者和/或照护提供者。 申请者能够证明其位于英国，并且在提交豁免申请之前已从MHRA获得微型或小型企业资格。 参见小型和微型企业的定义。 检查您是否符合创新器械标准 本节介绍如何完成下文详述的豁免申请流程的第2步。 如需核查您是否符合创新器械标准，请向 CI-applications@mhra.gov.uk 发送一封附函，内容包括： 对器械的全面描述，以及 其如何符合上述三项创新器械标准，以及 拟开展的临床研究的简要概述 除附函外，请提供您在豁免申请流程第1步中从MHRA收到的中小企业确认。 临床研究团队将在收到信息后5个工作日内进行审核，并确认以下事项： 该研究是否符合创新器械标准，以及 是否有可授予的费用豁免。 豁免申请流程 计划向MHRA提交豁免申请的申请人应首先按照此处流程从MHRA获得小企业或微型企业资格。 一旦获得小企业或微型企业资格，申请人应向MHRA核实其器械是否符合该计划的创新器械标准。有关如何操作的指导见上一节。 一旦MHRA确认符合资格，申请人应继续通过IRAS提交其申请。 此举应在联系MHRA后尽快完成，以确保豁免的持续可用性。 MHRA将按照标准流程对申请进行验证；如果申请有效，申请人将被告知已获授予费用豁免。如果申请被视为无效，申请人将被告知该决定的理由，并有机会重新提交申请。当申请人打算重新提交申请以供验证时，他们可通过联系CI-applications@mhra.gov.uk重新确认豁免是否可用。 更多信息 有关申请中小企业（SME）地位的指南，请参见小型和中型公司的付款减免和豁免。 如果您对费用豁免试点有进一步问题，请发送电子邮件至CI-applications@mhra.gov.uk。 如需了解正在进行的SME地位申请的最新进展，请联系sales-invoices@mhra.gov.uk。 开始您的申请 如何向MHRA通知您的临床研究 通过IRAS开始您的申请。申请使用综合研究申请系统（IRAS）以电子方式提交。 MHRA指南 在准备您的通知申请时，请阅读关于汇编提交材料的指南以及大不列颠制造商指南或北爱尔兰制造商指南。 了解MHRA如何批准我们获通知的临床研究。 阅读我们为临床研究者提供的信息，了解参与研究的临床医生需要做什么。 查阅临床研究的电气指南。 查阅我们关于临床研究中医疗器械生物学安全性评估的指南。 检查临床研究的统计学考量，以呈现您临床研究的统计信息。 阅读关于将人因工程和可用性工程应用于医疗器械（包括药械组合产品）的指南。 参见关于UKCA标记的指南。 验证清单 当我们收到您的医疗器械临床研究申请时，我们的监管处理人员将依据临床研究申请清单对您的申请进行验证。请使用此清单来帮助您提交有效的申请。 评估 本节仅涉及在大不列颠进行的临床研究。涉及北爱尔兰的研究请参见下方单独章节。 当我们收到您的文件并完成验证后，我们将在5个工作日内与您联系，确认60天评估期已开始，或者告知您是否存在任何问题。如果我们提出问题，60天评估期将在我们收到有效回复时开始。 60天中的第1天为有效申请受理日期之后的第二天。例如，如果申请于8月24日收到，评估人员于8月28日验证提交材料，则计时从8月29日开始。 在评估期间，专家将评估您器械的安全性和性能，以及将要开展的临床研究的设计。如果我们需要进一步信息，会致函给您。如果您需要澄清说明，务必尽快联系我们。 如果存在可能的反对理由，我们将尽可能安排电话会议，以便更好地理解并在60天评估期内找到解决方案。 我们将在第60天前致函您，告知决定（“反对”或“无反对”），说明您是否可以开展拟议的临床研究。 研究性药品与医疗器械的申请——平行审评 该申请途径适用于同时属于研究性药品临床试验（CTIMP）和医疗器械临床研究（CI）的临床研究。 出现此种情形时，研究应作为“平行审评”申请提交至MHRA（前称为研究性药品与研究性医疗器械联合试验（IMP+Device））。 请参阅平行审评外部指南。 该途径旨在弥合两套独立法规、立法时限和系统功能之间的差距。 从长远来看，MHRA临床研究与试验部门的意图是尽可能对齐法规和流程，为平行审评研究创造简化的提交体验。 另请参阅最新的临床试验指南：药品：临床试验中心 - GOV.UK 修订 本节仅涉及在大不列颠进行的临床研究。涉及北爱尔兰的研究请参阅下方单独章节。 一旦您收到我方出具的无异议函，您必须将所有拟议的研究修订通知我方。在您做出变更之前，必须等待我方向您发送另一份无异议函。 您必须告知我方对以下内容所做的任何变更： 研究中的器械 研究文档，包括临床研究计划 研究者或研究机构 伦理委员会要求的变更 如果您未告知我方拟议的修订，您可能面临起诉。 在HRA IRAS上开始提交您的修订。 请参阅IRAS用户指南中关于修订的章节。 当您向MHRA通知修订时，请包括以下内容： 一封附函，注明临床研究的MHRA参考编号（例如，CI/2023/XXXX） 一张表格，汇总每项拟议变更及其变更理由 所有修订研究文档的修订标记版（显示所做的变更）和清洁版 由制造商或代表制造商签署的声明，说明拟议变更不会可预见地增加对患者、使用者或第三方的风险 如果您未遵循上述指南，提交材料将被退回给您。 请将修订内容通过电子邮件发送至 CI-amendments@mhra.gov.uk，除非文件过大，在这种情况下请通过同一电子邮件地址联系我们，以请求获取上传文件的链接。我们仅处理提交至该邮箱的修订。请勿将修订提交给个人或任何其他邮箱。 修订的费用 根据2025年7月实施的新收费规定，对临床试验研究的任何修订均无需付费。 报告要求 严重不良事件（SAE）报告 本节涉及在大不列颠设有研究中心的临床研究，以及在英国大不列颠和北爱尔兰均设有研究中心的临床研究。仅在北爱尔兰设有研究中心（在大不列颠无研究中心）的研究请参见下方单独章节。 根据英国法规和MEDDEV 2.7/3，所有应报告事件必须完整记录并通知MHRA。这包括所有严重不良事件，无论该器械是否被评估为具有因果关系，以及在第三国按照同一临床研究计划开展临床研究时发生的应报告事件（依据MEDDEV 2.7/3）。这些信息可使用MEDDEV 2.7/3 SAE报告表或MDCG 2020-10/2 SAE报告表提供，只要包含所需信息即可。 请在新的MORE门户中提交SAE报告表，并附上填写完整的表格。 有关如何注册MORE门户的详细信息，请参阅相关内容。 MEDDEV 2.7/3还包含有关大不列颠临床研究报告的进一步指导。 季度总结报告（QSR） 作为MHRA批准临床研究的一项条件，除了如上文详述报告个别严重不良事件外，您还必须向我们发送季度总结报告，提供该研究最新总体安全性概况的更新。 如果研究仅在英国进行，我们期望第一份QSR在首位参与者接受治疗后的一个季度提交。 对于同时设有欧盟和全球站点的研究，请在MHRA批准英国研究后的一个季度提供QSR。报告应详细说明所有研究站点的总体安全性概况。 为提供这些总结，请使用 季度总结报告——制造商/申办方指南和模板（PDF，375 KB，6页）。该模板仅适用于器械，但对于任何联合研究中的器械相关报告，您也应使用该模板。请勿包含任何正在研究的试验用药品（IMP）的详细信息。 通过MORE门户直接提交您的季度总结报告 关于在MORE上提交SAE和QSR的进一步指南，请参见MORE提交——用户参考指南。 研究偏离 申办方必须在知悉所有偏离（仅涉及英国研究站点）后尽快通知MHRA。包括有关偏离性质的详细信息、发生时间、发生地点以及任何拟议的纠正和预防措施。 报告偏离时，请使用以下MHRA方案偏离跟踪Excel模板，并将其作为“实时”文档保存，以便可以添加新的偏离。这使申办者双方
正文 · 英文原文
Guidance Clinical investigations for medical devices How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. From: Medicines and Healthcare products Regulatory Agency Published: 18 December 2014 Last updated: 6 November 2026 — See all updates Get emails about this page Print this page Contents Does my study require a clinical investigation application? Contact us Fees Payment for a clinical investigation Payment easements for small, and medium enterprises Medical device clinical investigation fee waiver programme for micro and small sized enterprises Getting started on your application Assessment Applications for an investigative medicinal product and medical device - Parallel Review Amendments Reporting requirements Northern Ireland Medical devices: clinical investigations and performance studies in Northern Ireland Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval More information You may need to carry out a clinical investigation as part of the process to obtain a UKCA, CE or CE UKNI marking for your medical device. You must inform the MHRA if you are planning to do this at least 60 days before starting your investigation. Does my study require a clinical investigation application? For studies in Great Britain, please use this flow chart and accompanying guidance to determine if you need to submit an application to MHRA. In August 2025, MHRA published updated versions of these documents. Please review the latest available guidance and ensure you are aware of its contents with respect to clinical investigation applications from this date. For studies in Northern Ireland or Great Britain and Northern Ireland, use the flow chart and accompanying guidance in the Northern Ireland section. Note: a notification to the MHRA will not be required for medical devices that are UKCA, CE or CE UKNI marked for the purpose that is under investigation. Applications under Annex XVI of the Medical Device Regulation (EU) 2017/745 (MDR) for devices with no intended medical purpose cannot be accepted in GB. Special circumstances for healthcare establishments You do not need to notify us of a clinical investigation if: you have manufactured the medical device in-house for your own patients with no objective to place it on the market You may need to notify the MHRA of a clinical investigation if: you want to provide a medical device to another organisation, that up until now has been manufactured in-house for patients, for data to support safety and performance of a commercial product Read more about the Health Institution Exemption for general medical devices to find out whether an exemption applies to your study. Please refer to the flow chart and accompanying guidance to help determine if you need to submit an application to MHRA. Contact us Clinical investigation enquiries For specific enquires relating to applications for clinical investigations, contact info@mhra.gov.uk and ensure you add ‘clinical investigation enquiry’ in the subject line. Regulatory advice meetings The MHRA clinical investigations team can offer a comprehensive device regulatory advice meeting. We cannot review individual documents but we can provide guidance on navigating the regulatory landscape. See our information on fees regarding the charges for a regulatory advice meeting To request a regulatory advice meeting, contact the Head of Clinical Investigations mark.grumbridge@mhra.gov.uk. Fees See section 7 of our fees page. A fee under the Medical Devices Regulations 2002: (a) shall be payable when the notice to which it relates is given to the Secretary of State; and (b) shall accompany that notice when it is given. The fees detailed on our fees page also cover applications for device studies in Northern Ireland Payment for a clinical investigation How to make a payment to MHRA. We will create an invoice for the payment and to assist us with the invoice please ensure you provide us with a purchase order number as soon as possible and confirm who is responsible for the payment. Once you have received your invoice and made the payment, you should send evidence of payment by email to CI-applications@mhra.gov.uk and your assigned Regulatory Handler, quoting the MHRA reference (CI/XXXX/XXX). We will not provide a final regulatory decision (approval or objection letter) on the application until we have received payment. Payment easements for small, and medium enterprises Easements are available to SME for clinical investigations. At the point of submission of the application you must provide the MHRA SME approval letter for the easement to be considered. Upon receipt of a validation of an application MHRA will request 50% of the fee and the remaining 50% will be payable within six months after the first invoice has been issued. If the final 50% of the outstanding fee is not paid, then any approval letter for a clinical investigation provided by MHRA will be revoked resulting in the clinical investigation being stopped. In the case of an objection or a withdrawal of an application the remaining fee is due No easement is offered for device regulatory advice meetings For further information, see Payment easements and waivers for small and medium companies Medical device clinical investigation fee waiver programme for micro and small sized enterprises Fee waiver programme for micro and small sized enterprises intending to conduct clinical investigations with innovative medical devices The MHRA is extending its fee waiver programme into 2026-2027, beginning 20 April 2026. A total of ten clinical investigation application fee waivers will be available for eligible small and micro sized UK enterprises. The programme aims to support patient access to innovative devices by testing the impact of removing regulatory costs for smaller sized enterprises, where fees might act as a barrier to growth or innovation. Fee waiver programme details Duration: The programme will run from 20 April 2026 until 5 April 2027 or until such time as all fee waivers have been granted. Waivers available: A total of ten fee waivers will be available for Class I, IIa, IIb and, now also include Class III, but not active implantable devices. Effect: The usual clinical investigation application fee will be completely waived for successful applicants. Note: Only one waiver per applicant can be approved We will accept applications for studies where it involves a CTIMP however, the fee waiver is only for the device aspect of the application and the full fee is still payable for the CTIMP review Waiver eligibility conditions To be eligible, the following conditions must be met: The applicant can show the device meets the following criteria for an “innovative device”: the product is either new or a novel modification of existing technologies; there are no solutions that fulfil the same clinical need that have regulatory approval in the UK; and the device can be scaled with the end goal of benefiting the health and social care system, patients and/or care providers. The applicant can show they are based in the UK, and they have obtained micro or small enterprise status from the MHRA prior to submitting their waver application. See definitions for small and micro sized enterprises. Check whether you meet innovative device criteria This section covers how to complete step 2 of the waiver application process detailed below. To check whether you meet the innovative device criteria, please send a cover letter to CI-applications@mhra.gov.uk containing: a comprehensive description of the device, and how it meets the three innovative device criteria mentioned above, and a brief summary of the planned clinical investigation Alongside the cover letter, please provide the SME confirmation you have received from MHRA as part of step 1 of the waiver application process. The Clinical Investigations team will review the information provided within 5 working days of receipt and will confirm the following: whether the study meets innovative device criteria, and whether there are fee waivers available to be granted. Waiver Application process Applicants planning to submit a waiver application to MHRA should first obtain small or micro enterprise status from the MHRA by following the process here. Once small or micro status has been obtained, the application should check with MHRA whether their device meets the innovative device criteria for the programme. Guidance on how to do this is given in the section above. Once the MHRA have confirmed eligibility, the applicant should proceed to submit their application on IRAS. This should be done as soon as possible after contacting MHRA to ensure the ongoing availability of waivers. The MHRA will validate the application in the accordance with standard processes and, if valid, the applicant will be notified that a fee waiver has been granted. If the application is deemed invalid, the applicant will be notified of the reasons for this decision and have an opportunity to resubmit the application. When the applicant intends to resubmit the application for validation, they may re-confirm that waivers are available by contacting CI-applications@mhra.gov.uk. Further information For guidance on applying for SME status, see Payment easements and waivers for small and medium companies. Email CI-applications@mhra.gov.uk if you have further questions regarding the fee waiver pilot. For updates on an ongoing SME status application, please contact sales-invoices@mhra.gov.uk. Getting started on your application How to notify the MHRA of your clinical investigation Start your application via IRAS. Applications are submitted electronically using the Integrated Research Application System (IRAS). MHRA guidance Read the guidance on compiling a submission and guidance for manufacturers in Great Britain or guidance for manufacturers in Northern Ireland when preparing your notification application. Find out how the MHRA approves clinical investigations we are notified about. Read our information for clinical investigators to find out what is required by clinicians involved in the investigation. Check the electrical guidance for clinical investigations. Check our guidance on biological safety assessment of medical devices under clinical investigation. Check statistical considerations for clinical investigations for presenting statistical information for your clinical investigation. Read the guidance on applying human factors and usability engineering to medical devices including drug-device combination products. See the guidance on UKCA markings. Validation checklist When we receive your application for a clinical investigation of a medical device our regulatory handers will validate your application against the Clinical investigation application checklist. Use this checklist to help you submit a valid application. Assessment This section concerns clinical investigations being conducted in Great Britain only. See the separate section below for studies involving Northern Ireland. When we have received your documents and validated them, we will contact to you within 5 working days to confirm that the 60-day assessment period has started, or we will let you know if there are any issues. If we raise any issues, the 60-day assessment period will start when we receive a valid response. Day 1 of the 60 days is taken as being the first day that follows the date of acceptance of a valid application. For example, if an application is received on 24 August and the assessor validates the submission on 28 August, the clock starts on 29 August. During the assessment, experts will assess the safety and performance of your device as well as the design of the clinical investigation to be carried out. We will write to you if we require further information. It is essential that you contact us as soon as possible if you require clarification. If there are possible grounds for objection, where possible we will arrange a teleconference for a better understanding and to find a resolution within the 60-day assessment time. We will send you a letter by the 60th day with a decision (‘objection’ or ‘no objection’) whether or not you can carry out the proposed clinical investigation. Applications for an investigative medicinal product and medical device - Parallel Review This application pathway applies to clinical studies which are both a Clinical Trial of an Investigational Medicinal Product (CTIMP) and a Clinical Investigation (CI) of a medical device. Where this scenario arises, studies should be submitted to MHRA as a “Parallel Review” application (formerly known as a combined trial of an investigative medicinal product and an investigational medical device (IMP+Device)). Please see the Parallel review external guidance. The pathway is intended to bridge the gap between two separate sets of legislation, legislative timescales and system functionality. In the long term, MHRA Clinical Investigations and Trials Unit’s intention is to align regulations and processes as much as possible to create a streamlined submission experience for Parallel Review studies. Please also see the latest guidance on clinical trials: Medicines: clinical trials hub - GOV.UK Amendments This section concerns clinical investigations conducted in Great Britain only. See the separate section below for studies involving Northern Ireland. Once you’ve received a letter of no objection from us, you must notify us of all proposed amendments to the investigation. You must wait until we send you another letter of no objection before you make the changes. You must tell us about any changes made to: the device under investigation study documentation, including the clinical investigation plan investigators or investigating institutions changes requested by an ethics committee If you do not tell us about proposed amendments, you could be liable to prosecution. Begin your amendment submission on HRA IRAS. Refer to the IRAS user guide’s section on amendments. When you notify the MHRA of amendments, include the following: a covering letter with the MHRA reference number for the clinical investigation (for example, CI/2023/XXXX) a table with a summary of each proposed change with the justification for each change red-lined (showing changes being made) and clean copies of all amended study documentation a signed statement by, or on behalf of, the manufacturer that the proposed change(s) do not predictably increase the risk to the patient, user or third party If you do not follow the guidance above, the submission will be returned to you. Email the amendments to CI-amendments@mhra.gov.uk, unless the files are too big, in which case contact us at the same email address to request a link for uploading the documents. We will only process amendments submitted to this mailbox. Do not submit amendments to individuals or any other mailbox. Payment for an amendment Under the new fees implemented in July 2025 there is no fee payable for any amendment to a clinical investigation. Reporting requirements Serious adverse event (SAE) reporting This section concerns clinical investigations with sites in Great Britain, and clinical investigations with sites in both Great Britain and Northern Ireland. Please see the separate section below for studies with Northern Ireland sites only (no sites in Great Britain). In line with UK Regulations and MEDDEV 2.7/3, all reportable events must be fully recorded and notified to the MHRA. This includes all serious adverse events, irrespective of whether the device has been assessed as having a causal relationship, and reportable events (per MEDDEV 2.7/3) occurring in third countries in which a clinical investigation is performed under the same clinical investigation plan. These can be provided using either the MEDDEV 2.7/3 SAE reporting table, or the MDCG 2020-10/2 SAE reporting table, as long as the required information is included. Please submit an SAE reporting form in the new MORE portal with your completed table attached. See details on how to register for the MORE portal. MEDDEV 2.7/3 also contains further guidance on clinical investigation reporting in Great Britain. Quarterly summary reports (QSR) As a condition of MHRA approval for a clinical investigation, in addition reporting individual serious adverse events as detailed above, you must send us quarterly summary reports providing an update on the latest overall safety profile for the investigation. If the study is UK only, we expect the first QSR to be submitted one quarter after the first participant has been treated. For studies that also have EU and global sites please provide a QSR one quarter after MHRA approval of the UK study. The report should detail the overall safety profile for ALL study sites. To provide these summaries, use Quarterly Summary Reports – guidance and template for manufacturers / sponsors (PDF, 375 KB, 6 pages). This template is for devices only but you should also use it for device-related reporting on any combined studies. Do not include detail on any investigational medicinal product (IMP) under investigation. Submit your quarterly summary reports directly through the MORE portal Further guidance on submitting SAEs and QSRs on MORE can be found in the MORE Submissions - user reference guide. Study deviations Sponsors must notify the MHRA of all deviations (relating to UK study sites only) as soon as they are aware of them. Include details about the nature of the deviation, when it occurred, where it occurred, and any proposed corrective and preventative actions. Use the following MHRA protocol deviation tracker Excel template when reporting deviations and keep this as a ‘live’ document so that new deviations can be added. This enables both the sponsor
摘要 待译
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.