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一文讀懂按照MDR辦理醫療器械CE認證
發布日期:2021-08-24 18:41瀏覽次數:1363次
剛剛,在歐盟官網看到一篇有關制造商按照MDR辦理醫療器械CE認證?的指引文件,寫的非常簡明。在此分享給大家。

剛剛,在歐盟官網看到一篇有關制造商按照MDR辦理醫療器械CE認證的指引文件,寫的非常簡明。在此分享給大家。

醫療器械CE認證.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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