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一文读懂按照MDR办理医疗器械CE认证
发布日期:2021-08-24 18:41浏览次数:1127次
刚刚,在欧盟官网看到一篇有关制造商按照MDR办理医疗器械CE认证?的指引文件,写的非常简明。在此分享给大家。

刚刚,在欧盟官网看到一篇有关制造商按照MDR办理医疗器械CE认证的指引文件,写的非常简明。在此分享给大家。

医疗器械CE认证.jpg

Step by step guide to compliance for manufacturers

The manufacturer has the main role in complying with the EU MDR. Considering that both the device and the manufacturer must comply with the EU MDR, the manufacturer has by far the largest number of obligations to fulfil.

The linked pages describe a step by step approach to compliance which should be applicable to the majority of manufacturers and devices. There is no single formula however, and the  described approach will likely require adjusting to the specifics of the manufacturer and device concerned.

Step 1: Decide the intended use and classification

Step 2: Establish the necessary processes and resources

Step 3: Minimise the risks and fulfil the general requirements

Step 4: Complete the clinical evaluation

Step 5: Compile the technical documentation

Step 6: Make arrangements for distribution

Step 7: Register the device and the manufacturer

Step 8: Complete the conformity assessment

Step 9: Complete the final administrative procedures before launch

Step 10: Fulfil the obligations of the post market phase


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