MDR不太清楚。
MDD可以不申请13485证书，仅申请CE认证，审核时体系还是按照13485来审核；基本上体系还是需要按照13485建立的，再补充MDD的特殊法规要求。
MDR中 QMS要求如下：
制造商应确保采取必要程序，以使批量生产符合本法规的要求。应及时充分考虑器械设计或特性的更改和协调标准或器械符合性所声明的CS的更改。器械（非研究用器械）制造商应以最有效的及根据风险等级和器械类别的方式确立、记录、实现、维护、不断更新和不断改善一个能确保器械符合本法规规定的质量管理体系。
Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
质量管理体系包括制造商组织的所有处理流程、程序和器械质量的组成部分。它管理着结构、职责、程序、流程和管理资源，以贯彻所需的原则和行动，以遵守本法规的规定。The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.
质量管理体系应至少解决以下方面的问题：
The quality management system shall address atleast the following aspects:
(a) 法规符合性战略，包括符合性评估流程的符合性和系统所涵盖的器械的变更管理程序；
astrategy for regulatory compliance, including compliance with conformityassessment procedures and procedures for management of modifications to thedevices covered by the system;
(b) 确定适用的通用安全与性能要求，寻找可选择的解决这些要求的方法；
identificationof applicable general safety and performance requirements and exploration ofoptions to address those requirements;
(c) 管理责任；responsibility of the management;
(d) 资源管理，包括选择和管理供应商和分包商；
resource management, includingselection and control of suppliers and sub-contractors;
(e) 附录I第3节中规定的风险管理；risk management as set out in Section 3 of Annex I;
(f) 临床评价，根据第61条和附录XIV的规定，包括PMCF；clinicalevaluation in accordance with Article 61 and Annex XIV, includingPMCF;
(g) 产品实现规划，包括规划、设计、研发、生产和服务提供；product realisation, including planning, design, development, productionand service provision;
(h) 根据第27（3）条规定验证所有相关器械的UDI分配，确保根据第29条提供的信息的一致性和有效性；verification of the UDI assignments made in accordance withArticle 27(3) to all relevant devices and ensuring consistency andvalidity of information provided in accordance with Article 29;
(j) 根据第83条的要求，建立、实施和维护上市后监管体系；setting-up, implementation and maintenance of a post-market surveillancesystem, in accordance with Article 83;
(j) 与主管机构、公告机构、其他经济运营商、客户和/或其他利益相关人沟通；handling communication with competent authorities, notified bodies,other economic operators, customers and/or other stakeholders;
(k) 警戒情况下的严重事件和现场安全纠正措施的报告流程；processes for reporting of serious incidents and field safety correctiveactions in the context of vigilance;
(l) 纠正措施和预防措施的管理及其有效性的验证；management of corrective and preventive actions and verification oftheir effectiveness;
(m) 产品的监督和测量流程，数据分析和产品改进。processes for monitoring and measurement of output, data analysis andproduct improvement.
13485的主要包括质量管理体系(一般要求与文件要求)、 管理职责、资源管理、产品实现、测量与改进。13485能覆盖MDR QMS的大部分要求，但还要补充一些具体的法规要求，如UDI、临床评价、上市后监督、警戒条件下的严重事件和现场纠正措施报告等。
| 
[复制链接]
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2020-9-9 11:24:52
置顶卡
变色卡
楼主