PDF(Pubmed)
Abstract：
BACKGROUND: The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established process of Notified Body reviews. These experts provide a review and opinion that ultimately is taken into consideration alongside the information reviewed by the Notified Body during the review process. Four expert committees (General and Plastic Surgery and Dentistry; Orthopaedics, Traumatology, Rehabilitation, Rheumatology; Circulatory System; and Neurology) have published at least one Scientific Opinion (SO) under the Clinical Evaluation Consultation Procedure (CECP) in 2021-2022.
METHODS: The four expert committees with published CECP opinions were reviewed to assess the academic backgrounds and professional expertise of each member with respect to clinical, technical, and biological domains on a 0-2 scale for each domain. A content review was conducted on the 10 CECP opinions published by these committees to assess their consistency with the goals and outcome expectations set by the MDR. The extent of content related to each of the clinical, technical, and biological domains was also assessed on a 0-2 scale.
RESULTS: All committees were composed primarily by members with strong clinical expertise, but only a few had strong technical and biological expertise. Across committees, the average scores of members related to academic background and professional expertise both ranged from 1.64 to 2.00 in the clinical domain, but only 0-0.15 and 0.15-0.69, respectively, in the biological domain, and 0.12-0.55 and 0.23-0.73, respectively, in the technical domain. A content review for the 10 SOs showed that all opinions focused exclusively or primarily on the clinical evidence. Three contained a modest amount of additional text directed at technical/engineering issues and five at biological issues.
CONCLUSIONS: Expert committees are composed predominantly of expert clinical reviewers but have many fewer members with significant technical or biological expertise. This may limit the ability of the committees to evaluate the significant technical and biological risks that are often best understood by preclinical testing. Broadening the expertise across the committees may improve the depth of their benefit/risk critiques.
METHODS: The four expert committees with published CECP opinions were reviewed to assess the academic backgrounds and professional expertise of each member with respect to clinical, technical, and biological domains on a 0-2 scale for each domain. A content review was conducted on the 10 CECP opinions published by these committees to assess their consistency with the goals and outcome expectations set by the MDR. The extent of content related to each of the clinical, technical, and biological domains was also assessed on a 0-2 scale.
RESULTS: All committees were composed primarily by members with strong clinical expertise, but only a few had strong technical and biological expertise. Across committees, the average scores of members related to academic background and professional expertise both ranged from 1.64 to 2.00 in the clinical domain, but only 0-0.15 and 0.15-0.69, respectively, in the biological domain, and 0.12-0.55 and 0.23-0.73, respectively, in the technical domain. A content review for the 10 SOs showed that all opinions focused exclusively or primarily on the clinical evidence. Three contained a modest amount of additional text directed at technical/engineering issues and five at biological issues.
CONCLUSIONS: Expert committees are composed predominantly of expert clinical reviewers but have many fewer members with significant technical or biological expertise. This may limit the ability of the committees to evaluate the significant technical and biological risks that are often best understood by preclinical testing. Broadening the expertise across the committees may improve the depth of their benefit/risk critiques.
摘要：
背景：新的欧盟医疗器械法规（MDR）更加重视临床证据在建立安全性和性能方面的作用。MDR第54条要求专家委员会独立审查科学，技术,和临床证据支持某些新型设备的市场授权，独立于公告机构审查的既定流程。这些专家提供审查和意见，最终在审查过程中与公告机构审查的信息一起考虑。四个专家委员会(普通和整形外科和牙科；骨科，创伤学,康复,风湿病学；循环系统和神经病学）在2021-2022年的临床评估咨询程序（CECP）下发表了至少一项科学意见（SO）。
方法：对发表了CECP意见的四个专家委员会进行了审查，以评估每个成员在临床，技术,和每个域的0-2级生物域。对这些委员会发布的10项CECP意见进行了内容审查，以评估其与MDR设定的目标和结果预期的一致性。内容与每个临床相关的程度，技术,和生物学结构域也以0-2量表进行评估。
结果：所有委员会主要由具有强大临床专业知识的成员组成，但只有少数人拥有强大的技术和生物学专业知识。跨委员会，与学术背景和专业知识相关的成员在临床领域的平均得分都在1.64到2.00之间，但分别只有0-0.15和0.15-0.69，在生物领域，分别为0.12-0.55和0.23-0.73，在技术领域。对10个SO的内容审查表明，所有意见都专门或主要集中在临床证据上。三个包含少量针对技术/工程问题的补充文本，五个针对生物学问题。
结论：专家委员会主要由专家临床评审员组成，但具有重要技术或生物学专业知识的成员较少。这可能会限制委员会评估通常通过临床前测试最好理解的重大技术和生物风险的能力。扩大各委员会的专业知识可能会提高其利益/风险批评的深度。
方法：对发表了CECP意见的四个专家委员会进行了审查，以评估每个成员在临床，技术,和每个域的0-2级生物域。对这些委员会发布的10项CECP意见进行了内容审查，以评估其与MDR设定的目标和结果预期的一致性。内容与每个临床相关的程度，技术,和生物学结构域也以0-2量表进行评估。
结果：所有委员会主要由具有强大临床专业知识的成员组成，但只有少数人拥有强大的技术和生物学专业知识。跨委员会，与学术背景和专业知识相关的成员在临床领域的平均得分都在1.64到2.00之间，但分别只有0-0.15和0.15-0.69，在生物领域，分别为0.12-0.55和0.23-0.73，在技术领域。对10个SO的内容审查表明，所有意见都专门或主要集中在临床证据上。三个包含少量针对技术/工程问题的补充文本，五个针对生物学问题。
结论：专家委员会主要由专家临床评审员组成，但具有重要技术或生物学专业知识的成员较少。这可能会限制委员会评估通常通过临床前测试最好理解的重大技术和生物风险的能力。扩大各委员会的专业知识可能会提高其利益/风险批评的深度。
