S.L. 458.59 Art. 10Obligation of economic operators to transmit complaints to competent authority.

(1) Any economic operator that has received complaints or reports from healthcare professionals, patients or users about incidents related to a medical device which they have made available on the local market, shall immediately forward this information to the competent authority.

(2) Every economic operator shall keep a register containing details of complaints, of non-conforming medical devices and of recalls and withdrawals of medical devices, and shall keep the competent authority informed of such monitoring.

(3) The competent authority may request any other information from any person or entity as it may deem necessary for the carrying out of its functions pursuant to these regulations.