In an effort to bring its guid­ance doc­u­ments on clin­i­cal eval­u­a­tion up to date, the Inter­na­tion­al Med­ical Device Reg­u­la­tors Forum (IMDRF) has asked for feed­back on pro­posed revi­sions to three doc­u­ments, includ­ing how to demon­strate equiv­a­lence to com­pa­ra­ble devices. 

The pro­posed revi­sions for pub­lic con­sul­ta­tion are indi­cat­ed in each of the rel­e­vant guid­ance doc­u­ments – the doc­u­ments are freely avail­able (please let us know, should you require a copy):

  1. Clin­i­cal Eval­u­a­tion (pre­vi­ous­ly GHTF/SG5/N2R8:2007)
  2. Clin­i­cal Evi­dence-key def­i­n­i­tions and con­cepts (pre­vi­ous­ly GHTF/SG5/N1R8:2007)
  3. Clin­i­cal inves­ti­ga­tions (pre­vi­ous­ly GHTF/SG5/N3:2010)

A cru­cial fac­tor when devel­op­ing a new med­ical device is whether a clin­i­cal tri­al is oblig­a­tory or if clin­i­cal evi­dence may be (par­tial­ly) based on data from equiv­a­lent devices. The forum explains that a set of glob­al­ly har­mo­nized stan­dards might cut out the neces­si­ty of hav­ing to car­ry out addi­tion­al region­al clin­i­cal tri­als and encour­age the intro­duc­tion of devices in mul­ti­ple jurisdictions.

The IMDRF believes that the exist­ing SG5/N2R8 guid­ance on clin­i­cal eval­u­a­tion is inad­e­quate in help­ing man­u­fac­tur­ers who are try­ing to demon­strate equiv­a­lence of their new device to a com­pa­ra­ble device. Addi­tion­al­ly, since this was issued in 2007, sev­er­al juris­dic­tions have updat­ed and put into effect their oblig­a­tions on equiv­a­lence demon­stra­tion, such as the accep­tance lev­el of dif­fer­ences etc.

Read­ers are gen­er­al­ly encour­aged to review the pro­posed doc­u­ments – they may give fur­ther clar­i­ty about expec­ta­tions under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) because they are enhance­ments of the for­mer GHTF doc­u­ments on which MEDDEV 2.7/1, rev. 4 was based.

Sources: Medtech Insight (an Infor­ma prod­uct), bsi

If you require fur­ther infor­ma­tion on Clin­i­cal Eval­u­a­tion and cor­re­spond­ing topics

Vis­it our Sup­port­ive Infor­ma­tion Sec­tion regard­ing MDR / IVDR.
Check our Com­plete Down­load Sec­tion.
Browse our Com­plete Link Section.