EU-MDR
As of the 26th of May 2020, manufacturers must be able to present an EC certificate in accordance with the new MDR (Medical Device Regulation) when placing medical devices on the market for the first time.
If, for example, the manufacturer does not provide an EU Declaration of Conformity (EC certificate) within the specified period or if the technical documentation is incomplete, the authorities will not allow you to place your medical device on the market.