Device Master Record (DMR)

Definition of the term („Was is a Device Master Record?“)

A De­vice Mas­ter Re­cord is a tech­ni­cal pro­duct file with com­pi­la­ti­on of re­cords which in­clu­des the pro­ces­ses and spe­ci­fi­ca­ti­ons for an end pro­duct (FDA 21 CFR 820). The term De­vice Mas­ter Re­cord was coi­ned by the US Food and Drug Ad­mi­nis­tra­ti­on (FDA) and is part of the Qua­li­ty Sys­tem Re­gu­la­ti­on (QSR).  

What is the connection to the FDA?

As the de­ve­lo­p­ments in the sec­tor of me­di­cal de­vices have si­gni­fi­cant­ly in­cre­a­sed in re­cent ye­ars, the re­gu­la­ting ap­pro­val aut­ho­ri­ties are also con­stant­ly fa­cing new chal­len­ges. This way, the FDA (Food and Drug Ad­mi­nis­tra­ti­on) with its re­lia­bi­li­ty and strict re­gu­la­ti­on ser­ves as an in­ter­na­tio­nal mo­del. With re­fe­rence to the FDA, the De­vice Mas­ter Re­cord is an aspect of the ex­ten­si­ve do­cu­men­ta­ti­on sys­tem ai­ming at re­gu­la­ting the qua­li­ty ma­nage­ment of me­di­cal de­vices. While the FDA fo­cu­ses on de­vices of the US Ame­ri­can mar­ket, the re­vi­si­on of ISO 13485(:2016) and the as­so­cia­ted Me­di­cal De­vice File now also makes do­cu­men­ta­ti­on for qua­li­ty as­suran­ce man­da­to­ry in Europe. 

What does a Device Master Record contain?

  • In­ten­ded purpose
  • In­for­ma­ti­on on the struc­tu­re of the de­vice (sket­ches, com­po­si­ti­ons, com­pon­ents, soft­ware used)
  • Pro­duc­tion in­for­ma­ti­on (tools, pro­ces­ses, me­thods, pro­duc­tion re­qui­re­ments and specifications)
  • Qua­li­ty as­suran­ce pro­ce­du­res (me­thods, tools, etc.)
  • La­bel­ling in­for­ma­ti­on (pa­ck­a­ging, de­vice in­for­ma­ti­on, etc.)
  • In­stal­la­ti­on, main­ten­an­ce, sto­rage and trans­port in­st­ruc­tions in­clu­ding me­thods and tools

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