Why is a Clin­i­cal Eval­u­a­tion so Important?

Both, the Med­ical Devices Direc­tive 93/42/EEC (MDD) and Reg­u­la­tion (EU) 2017/745 on Med­ical Devices (MDR) require man­u­fac­tur­ers of med­ical devices to draw up a clin­i­cal eval­u­a­tion for their devices.

The over­all aim of a clin­i­cal eval­u­a­tion is to assess and ana­lyze clin­i­cal data regard­ing the med­ical device to pro­vide evi­dence for the product’s clin­i­cal safe­ty and performance.

Impor­tant inputs for the clin­i­cal eval­u­a­tion are pro­vid­ed by risk man­age­ment, design inputs, instruc­tions for use, clin­i­cal inves­ti­ga­tions, lit­er­a­ture reviews and PMS etc. 

Pre- and post-mar­ket clin­i­cal data that are rel­e­vant to the intend­ed use of a device con­sti­tute the basis of the eval­u­a­tion. Man­u­fac­tur­ers may include data spe­cif­ic to the device under eval­u­a­tion as well as data from equiv­a­lent devices (if equiv­a­lence may be claimed).

The out­put of the clin­i­cal eval­u­a­tion is the clin­i­cal eval­u­a­tion report. Clin­i­cal eval­u­a­tion is a con­tin­u­ous process that fol­lows the life-cycle of a device. With MEDDEV 2.7/1, rev. 4 and under the MDR, this process plays a cen­tral role in the CE Mark­ing of med­ical devices. It is close­ly aligned with oth­er impor­tant sec­tions, e.g. Post-Mar­ket Sur­veil­lance (PMS) and Risk Management.

Key Steps  

The over­all approach should com­prise sev­er­al key steps as out­lined below:

• Iden­ti­fi­ca­tion of reg­u­la­to­ry require­ments to be sup­port­ed by clin­i­cal data
• Iden­ti­fi­ca­tion of avail­able clin­i­cal data for the device under eval­u­a­tion and state of the art for the intend­ed use 
• Deter­mi­na­tion if there is suf­fi­cient clin­i­cal data for the safe­ty and per­for­mance of the device under evaluation
• If clin­i­cal data is not suf­fi­cient, gen­er­a­tion of addi­tion­al clin­i­cal data
• Deter­mi­na­tion of the device’s clin­i­cal safe­ty and per­for­mance and benefit/ risk ratio

Process

Impor­tant inputs for the clin­i­cal eval­u­a­tion are pro­vid­ed by risk man­age­ment, design inputs and prod­uct spec­i­fi­ca­tions, label­ing or instruc­tions for use respec­tive­ly, pre-clin­i­cal stud­ies, clin­i­cal inves­ti­ga­tions, lit­er­a­ture reviews and PMS. The out­puts of the clin­i­cal eval­u­a­tion, i.e. the clin­i­cal data on safe­ty and per­for­mance then feed back into the risk/ ben­e­fit analysis.

The guid­ance doc­u­ment MEDDEV 2.7/1, rev. 4 gives a schemat­ic overview of the dif­fer­ent stages of the clin­i­cal eval­u­a­tion process:

Source: MEDDEV 2.7/1, rev. 4

These have been large­ly adopt­ed by the MDR and may be used as a ref­er­ence until fur­ther guid­ance is available. 

Sources: MEDDEV 2.7/1, rev. 4, MDR

For more infor­ma­tion about clin­i­cal eval­u­a­tions please read our relat­ed top­ics as linked below

Check our down­load sec­tion of Guid­ance Doc­u­ments for the MDR.
Vis­it our Sup­port­ive Infor­ma­tion Sec­tion regard­ing MDR / IVDR.
Or get in con­tact with our team.