Till date, nei­ther the Euro­pean Com­mis­sion nor a relat­ed orga­ni­za­tion has issued an offi­cial guid­ance doc­u­ment on the med­ical devices reg­u­la­tion (MDR) and in vit­ro diag­nos­tic med­ical devices reg­u­la­tion (IVDR) post-mar­ket sur­veil­lance (PMS) require­ments. ISO/ TR 20416:2020 pro­vides valu­able assis­tance in this context.

Although stan­dards like ISO 13485 and ISO 14971 include require­ments on PMS, they do not focus entire­ly on this process. The Inter­na­tion­al Orga­ni­za­tion for Stan­dard­iza­tion has issued ISO/ TR 20416:2020 to close this gap: “The intent of this doc­u­ment is to pro­vide guid­ance to man­u­fac­tur­ers who are plan­ning and exe­cut­ing their post-mar­ket sur­veil­lance activ­i­ties” and should be read in con­junc­tion with ISO 13485 and ISO 14971. (ISO/ TR 20416:2020) 

Fig­ure 2 schema­tizes the inter­play between these stan­dards and the tech­ni­cal report.

Fig­ure 2.  Inter­play between ISO 13485, ISO 14971 and ISO TR 20416 (ISO/ TR 20416:2020)

ISO/ TR 2016:2020 pro­vides insights how a man­u­fac­tur­er should build the scope and objec­tive of the PMS Plan. More specif­i­cal­ly, it should con­sid­er aspects like the applic­a­ble reg­u­la­to­ry require­ments, the clas­si­fi­ca­tion, intend­ed use and also what ques­tions should be asked to estab­lish the PMS Plan objec­tives. (Inter­na­tion­al Orga­ni­za­tion for Stan­dard­iza­tion, 2020) The doc­u­ment con­tains a col­lec­tion of poten­tial data sources that a med­ical device pro­duc­er may use for the PMS plan­ning, and it also helps to spec­i­fy the cor­re­spond­ing col­lec­tion methods. 

What seems par­tic­u­lar­ly rel­e­vant is the guid­ance on the analy­sis of data. ISO/ TR 20416:2020 sug­gests qual­i­ta­tive and/ or quan­ti­ta­tive meth­ods depend­ing on the data sources and PMS Plan objec­tives. The out­put of the pre­vi­ous steps will then be the PMS Report refer­ring to the items pre­vi­ous­ly defined in the PMS Plan. Last­ly, the tech­ni­cal report pro­vides prac­ti­cal guid­ance by giv­ing fur­ther exam­ples of data analy­sis meth­ods and also by mak­ing avail­able PMS Plan sam­ples in the cor­re­spond­ing annexes. 

To sum­ma­rize, ISO/ TR 20416:2020 rep­re­sents a valu­able tool to imple­ment some essen­tial aspects of the MDR and IVDR PMS requirements

To sum­ma­rize, ISO/ TR 20416:2020 rep­re­sents a valu­able tool to imple­ment some essen­tial aspects of the MDR and IVDR PMS require­ments. Yet, the doc­u­ment does not cov­er all applic­a­ble require­ments.  For exam­ple, there is no guid­ance how to con­nect PMS to relat­ed process­es like risk man­age­ment or clin­i­cal eval­u­a­tion or the QMS in gen­er­al. In addi­tion, the items below, which are required in an MDR and IVDR com­pli­ant PMS Plan, have been con­sid­ered only briefly or at all:

Source: ISO/ TR 20416:2020

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