Issue with self-certification process for class I product according to MDR
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After you registered your class I medical device at the local national authority, usually you will receive a solution by which a Class I product can be placed on the market. And that is it. You can sell your products on the EU market.
The question here is only are you certified according to the ISO 13485:2016. If you are, then at each periodic audit, the auditor will review the technical file of your class I medical device.
Thank you so much, so you don't need to register with each national authority where you are putting your device on the national Market
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Feb 23, 2022