I have an issue with MDR certification for which I would like to get your advice. The issue is regarding to the self-certification process for a class I product according to MDR; the manufacturer being part of the EU.
Need for an UDI and basic-UDI, notification to the national authority where the manufacturer is established, declarationof conformity and then ?
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.