【奥译言】英国MHRA根据欧盟MDR对临床研究指南进行了修订

2019-08-05 15:54 阅读数：4186 标签：

英国药品和保健康产品管理局（MHRA）对2013版医疗器械临床研究指南进行了修订，以反映欧盟医疗器械法规（REGULATION(EU) 2017/745，简称“MDR”）的要求。

MHRA指南修订涉及具体的MDR法规，MDR于2017年生效，并将在2020年5月26日正式施行。MDR将正式取代欧盟医疗器械指令（MDD）（Directive93/42/EEC），紧接着，欧盟体外诊断医疗器械法规（REGULATION (EU) 2017/746，简称“IVDR”）也将于2022年5月26日正式施行，从而将正式取代欧盟体外诊断医疗器械指令（IVDD）（Directive98/79/EC）。

该指南指出，有关生物安全评价的立法规定的依据是MDR附录XV，而不是MDD附录VII。修订内容阐明了确保“临床试验受试者的预期收益大于可预见的风险”（MDR第62条）这一说法成立的必要性，并提交了足够的数据供审查，“以确保已充分考虑到了所有必要的毒理学风险。"

由于新修订指南不仅反映了MDR法规，还反映了关于医疗器械生物学评价的ISO 10993-1（2018版）的要求，因此有几项更新属于毒理学风险评估范围。该修订版指南的毒理学风险评估部分指出，“所需的物理表征范围具体取决于相关医疗器械，同时对于植入物和血液接触器械的评估尤为重要”。

而其他更新基于符合性评估要求，强调了需要从先前的基本要求过渡到MDR所规定的安全性和性能的一般要求。其中一项更新表明了MDR中的一项要求，即制造商必须证明含有少量致癌、致畸或生殖毒性物质（CMR），或含有可能对人类健康造成影响的内分泌干扰物质的合理性。另一项更新旨在最大程度降低纳米材料所带来的风险。

随着英国接近其新的"脱欧"最后期限（10月31日），英国对指南进行了修订。

上周，英国在议会上提出了药品和器械监管应急立法草案。一旦出现无协议脱欧的情况，MHRA计划采用与欧盟MDR和IVDR相同的过渡期。

业内人士称，英国脱欧是MDR过渡期间面临的诸多挑战之一。今年1月初，英国BSI成为欧盟新医疗器械法规MDR框架下正式指定的第一个公告机构。但总部位于伦敦的Lloyd'sRegister Quality Assurance公司于上个月表示，鉴于近期的市场发展情况，该公司将不会申请成为MDR和IVDR框架下的指定公告机构。英国UL本月早些时候向Focus表示，该公司“尚未申请MDR/IVDR下的指定”，并打算支持一家欧盟27国境内的公告机构，其理由是英国脱欧会对公告机构产生影响。SGS在2月份表示，该公司正在走MDR指定流程。距离MDR过渡期只剩下不到九个月时间，然而，到目前为止仅有两个公告机构被正式指定。

英文原文

MHRA Revises Clinical Investigation Guidance in Line With EU MDR

Posted 30 July 2019 | By Ana Mulero

The UK’s Medicines and Healthcare productsRegulatory Agency (MHRA) revised 2013 medical device clinical investigationguidance to reflect the EU’s medical device regulation (MDR).

Revisions to MHRA’s guidance considerspecific MDR changes, which were entered into force in 2017 and have a 26 May2020 date of application. MDR is set to repeal the EU’s medical devicedirective (MDD), followed by the in vitro diagnostic regulation’s (IVDR) 26 May2022 repeal of the IVD directive.

The guidance points to the legislativeprovisions relating to biological safety evaluation under Annex XV of MDR,rather than Annex VII of MDD. The first set of revisions introduces the needfor ensuring that the “anticipated benefits to the patients enrolled in theclinical trial justify the foreseeable risks,” in accordance with Article 62 ofMDR, and submitting sufficient data for review to “provide assurance that allnecessary toxicological risks have been appropriately considered.”

Several updates fall under toxicologicalrisk assessments as the guidance not only reflects MDR changes, but also the2018 version of the ISO 10993-1 standard on the biological and clinicalevaluation of medical devices. “The extent of physical characterizationrequired will be dependent on the medical device in question and isparticularly important in the assessment of implants and blood contactingdevices,” the revised toxicological risk assessment section says.

Other updates fall under conformityassessment requirements, underscoring the shift away from the previousessential requirements to MDR’s general safety and performance requirements.One update specifies a requirement in MDR that manufacturers must justify theinclusion of small amounts of substances classified as carcinogenic, mutagenicor toxic to reproduction, or substances whose endocrine disrupting propertiesprovides risk to human health. Another applies to minimizing the risks posed bynanomaterials.

Revisions come as the UK nears the new 31October Brexit deadline.

UK draft contingency legislation for drugand device regulation was laid in Parliament last week. MHRA intends to followthe same transitional periods as the EU for the application of MDR and IVDR inthe event of a no-deal scenario.

Industry has cited Brexit as one of the manychallenges to the MDR transition. BSI UK became the first notified body (NB) tobe designated against MDR in January. But London-based Lloyd's Register QualityAssurance said last month it will not apply to be designated against MDR norIVDR “following recent market developments.” UL UK told Focus earlier thismonth it “has not applied for designation under MDR/IVDR” and intends tosupport a EU27 NB, citing no-deal Brexit implications for NBs. SGS said inFebruary it is undergoing the process to become MDR-designated. With less thannine months left, only two NBs have been designated so far.

来源：RAPS

原文链接：

https://www.raps.org/news-and-articles/news-articles/2019/7/mhra-revises-clinical-investigation-guidance-in-li

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