ÚNMZ draws attention to the new MDCG document

The MDCG 2022-18 explains the conditions under which Article 97 of the MDR can be applied, allowing manufacturers to continue to supply products to the market that have expired certificates issued under the MDD or AIMDD and are not yet certified under the new legislation. In this context, the existing legislation will also be modified to reflect this de facto extension of the "legacy devices" regime. This is a transitional solution to facilitate the transition to MDRs and IVDRs for economic operators and to avoid a shortage of medical devices on the market, in line with the recommendations set out in MDCG 2022-14.