Dealing with certification gaps of medical devices (MDCG 2022-18)

13 gennaio 2023 – For medical devices in moderate and high-risk classes, the issuance of a conformity certificate by a designated body is mandatory under EU-law as well as Swiss law. A certification gap arises if a certificate issued under the old legislation (MDD or AIMDD) expires before a new certificate has been issued under the current regulation (MDR). In order to ensure the supply of medical devices in these cases, EU Position Paper MDCG 2022-18 provides for a solution for dealing with such certification gaps. In Switzerland, a solution equivalent to the EU approach is implemented.

For more information, see here.