The Euro­pean Com­mis­sion has issued new guid­ance doc­u­ments on the new nomen­cla­ture sys­tem EMDN that man­u­fac­tur­ers must use under the Med­ical Devices and IVD Med­ical Devices Reg­u­la­tion (EU) 2017/745 and 2017/746 (MDR and IVDR).

The EMDN sys­tem will base on the Ital­ian CND nomen­cla­ture sys­tem. The cor­re­spond­ing codes will be used – among oth­ers – for the reg­is­tra­tion process in EUDAMED. In this con­text, the Com­mis­sion has also issued an expla­na­tion and overview of the CND system.

Both doc­u­ments may pro­vide ini­tial details about the nomen­cla­ture sys­tem under the MDR and IVDR. 

In addi­tion, the Med­ical Device Coor­di­na­tion Group (MDCG) issued a guid­ance doc­u­ment on cyber­se­cu­ri­ty. The MDR and IVDR require man­u­fac­tur­ers to “devel­op and man­u­fac­ture their prod­ucts in accor­dance with the state of the art tak­ing into account the prin­ci­ples of risk man­age­ment, includ­ing infor­ma­tion secu­ri­ty, as well as to set out min­i­mum require­ments con­cern­ing IT secu­ri­ty mea­sures, includ­ing pro­tec­tion against unau­tho­rised access.”

A strong advice from us

The present guid­ance doc­u­ment is intend­ed to help man­u­fac­tur­ers to com­ply with the cor­re­spond­ing require­ments. It is strong­ly advised to review the document. 

Source: MDCG guid­ance documents

For more in depth infor­ma­tion on guid­ance doc­u­ments, we warm­ly rec­om­mend our fol­low­ing tags, arti­cles and pages