我如何为我的医疗器械办理认证？
根据(EU) 2017/745 号法规第 52 条，医疗器械获得 CE 标志的程序可能因风险类别不同而有所差异。
对于除定制或研究用设备之外的 I 类医疗器械，制造商可以通过出具符合性声明（MDR 第 19 条）来声明其符合 MDR 要求，并自行办理 CE 标志。
对于 I 类无菌医疗器械（Is）或具有测量功能的医疗器械（Im）或可重复使用的手术器械（Ir），以及 IIa、IIb 和 III 类（包括定制植入式医疗器械），始终需要公告机构的介入。Kiwa 可以开展的符合性评估活动在 Kiwa 的特定规定中进行了定义和描述。
在将设备投放市场之前，制造商必须选择要遵循的符合性评估程序，并使用特定表格向 Kiwa 提交预申请。Kiwa 将评估请求的可行性，以便发出报价，一旦接受，该报价将代表正式的符合性评估申请。
How to get certified: Step by step
The process is usually composed of the following steps.
Pre-application activities and quotation
Kiwa examines manufacturer’s pre-application information in order to confirm the feasibility of the project and to issue the quotation.
Application review and contract
Once received the official application signed by the manufacturer (signed quotation), Kiwa makes the application review in order to accept or to refuse the project. The outcome of each review will be documented and sent to the manufacturer.
Only if Kiwa's outcome is positive, the conformity assessment activities can start.
Documental Analysis
Kiwa evaluates of the whole technical documentation, including pre-clinical and clinical data, as well as related QMS procedures of the medical device, according to both the MDR chapters II and III, and the relevant conformity assessment annex chosen.
Specific procedures
For certain types of medical devices, as reported in art. 52 and 54 of the MDR, Kiwa carries out specific procedures referred to relevant sections of conformity assessment annexes chosen.
On-site Audit for initial certification
Kiwa evaluates the application to product lifecycle of the quality management system assessed during the documental analysis to ensure that the devices covered conform to the relevant provisions of the MDR (concept, design, production, final control and post-market surveillance).
Final review, decision and certification
Kiwa issues the EU Certificate following the positive results obtained by the final review and the decision making of all the conformity assessment activities carried out.
On-site Audit for surveillance and post-certification monitoring
Annual assessment to guarantee continuous fulfillment of the requirements of the Medical Devices Regulation.
Unannounced Audits
Kiwa carries out on-site audits without prior notice, at least once every 5 years, in addition to the surveillance audits; those audits will be conducted at the manufacturer's premises and, where applicable, at critical suppliers ones to verify the day to day compliance with legal obligations.
During the audits also tests on the medical device are conducted.
Recertification
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