You may already have asked your­self how Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) affects the Tech­ni­cal Doc­u­men­ta­tion require­ments for your prod­ucts. This is a very com­plex ques­tion and can­not be eas­i­ly answered as it depends on many aspects.

Base case

To pro­vide a more prac­ti­cal approach, mdi Europa has set up a brief case study to make clear what addi­tion­al aspects should be addressed com­pared to what is already required under the Med­ical Devices Direc­tive 93/42/EEC (MDD) and Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD): Assume you are a med­ical device man­u­fac­tur­er of a class IIb ortho­pe­dic implant, which will be “up-clas­si­fied” to III under the MDR – what aspects would have to be regard­ed? Please find below some considerations.

Tech­ni­cal Doc­u­men­ta­tion and prod­uct description

Espe­cial­ly man­u­fac­tur­ers of high risk devices should be aware that the cor­re­spond­ing doc­u­men­ta­tion will be reviewed with much more atten­tion and scrutiny. 

The MDR defines var­i­ous doc­u­men­ta­tion require­ments, which will be new for all man­u­fac­tur­ers, not only for those who pro­duce class III devices. How­ev­er, espe­cial­ly man­u­fac­tur­ers of high risk devices should be aware that the cor­re­spond­ing doc­u­men­ta­tion will be reviewed with much more atten­tion and scruti­ny – com­pared to low-risk prod­ucts. For exam­ple, annex II of the MDR demands that man­u­fac­tur­ers include the prin­ci­ples of oper­a­tion or mode of action of a device. The read­er shall be able to under­stand how exact­ly a prod­uct works.  This refers to the claim of the Reg­u­la­tion to pro­vide a high­er lev­el of control.

Mov­ing on this point, a Tech­ni­cal File under the MDR must include a ratio­nale why a prod­uct is a med­ical device and also jus­ti­fy in detail which risk class is applic­a­ble. Fur­ther­more, a man­u­fac­tur­er has to give ref­er­ence to pre­vi­ous and sim­i­lar device gen­er­a­tions and pro­vide extend­ed design process details includ­ing infor­ma­tion about sup­pli­ers and sub­con­trac­tors. By includ­ing these require­ments, the mak­ers of the Reg­u­la­tion oblige man­u­fac­tur­ers not only to con­sid­er all risk class­es that may apply and present a well-found­ed decision. 

They also ensure that med­ical device pro­duc­ers define design pro­ce­dures and gath­er mar­ket details, which aim to sup­port or can be fed back for exam­ple into the Post-Mar­ket Sur­veil­lance (PMS) sys­tem.  Espe­cial­ly man­u­fac­tur­ers of high-risk devices should expect high­er scruti­ny against these points and amend their doc­u­men­ta­tion accordingly. 

Tech­ni­cal Doc­u­men­ta­tion and Gen­er­al Safe­ty and Per­for­mance Requirements

Anoth­er impor­tant change comes with the new Gen­er­al Safe­ty and Per­for­mance Require­ments (SPR). Although valid for all class­es of devices, this change may prove to be par­tic­u­lar­ly crit­i­cal for class III device pro­duc­ers. In this con­text, the MDR also pro­vides for Com­mon Spec­i­fi­ca­tions (CS). CS may apply for areas where no har­mo­nized stan­dards can be referred to, to demon­strate com­pli­ance with the SPR. New­ly defined CS may require addi­tion­al doc­u­men­ta­tion. Espe­cial­ly high-risk device man­u­fac­tur­ers should pre­pare for an enhanced lev­el of reg­u­la­tion in com­par­i­son to low­er device classes. 

Against this back­ground, you should also review your label­ing. Man­u­fac­tur­ers must include new ele­ments on their labels, e.g. the UDI and the med­ical device sym­bol. Also, depend­ing on the device his­to­ry, your Noti­fied Body (NB) might judge the cur­rent infor­ma­tion on resid­ual risk, unde­sir­able side effects, clin­i­cal ben­e­fits, etc. as insufficient. 

Clin­i­cal eval­u­a­tion under the MDR

Man­u­fac­tur­ers are gen­er­al­ly expect­ed to include more own clin­i­cal data to pro­vide suf­fi­cient clin­i­cal evidence. 

Next, the require­ments for clin­i­cal eval­u­a­tion have changed under the MDR. What was avail­able in the MEDDEV 2.7/1, rev. 4 guid­ance doc­u­ment under the MDD is now large­ly includ­ed in the MDR and thus becomes a legal oblig­a­tion. One impli­ca­tion is that it will become much more dif­fi­cult to base an eval­u­a­tion on equiv­a­lence. Man­u­fac­tur­ers are gen­er­al­ly expect­ed to include more own clin­i­cal data to pro­vide suf­fi­cient clin­i­cal evidence. 

Con­tin­u­ing the point above, the MDR makes clin­i­cal inves­ti­ga­tions manda­to­ry for implantable and class III devices unless for cer­tain excep­tions. NBs will care­ful­ly review if the con­di­tions for these excep­tions are ful­filled. In addi­tion, under the MDR, the NB of a class III device man­u­fac­tur­er, will send a clin­i­cal eval­u­a­tion assess­ment report to an expert pan­el for an addi­tion­al review. 

Sum­ma­ry of Safe­ty and Clin­i­cal Performance

A com­plete­ly new MDR require­ment is that man­u­fac­tur­ers of high-risk med­ical devices must pre­pare a Sum­ma­ry of Safe­ty and Clin­i­cal Per­for­mance (SSCP). The doc­u­ment is reviewed by the NB and shall be pub­licly avail­able. The SSCP is intend­ed as a tool for the pub­lic “to make informed deci­sions about the iden­ti­fied med­ical device” (Source: Euro­pean Patients Forum). 

Tech­ni­cal Doc­u­men­ta­tion and PMS

The MDR pro­vi­sions regard­ing PMS also require amend­ments to your Tech­ni­cal Doc­u­men­ta­tion. Med­ical device man­u­fac­tur­ers have to com­pile var­i­ous doc­u­ments, which have not been pro­vid­ed for under the MDD (e.g. PMS Plan). Simul­ta­ne­ous­ly, the MDR intro­duces the oblig­a­tion to com­pile Peri­od­ic Safe­ty Update Reports (PSUR). The PSUR is basi­cal­ly a sum­ma­ry of analy­sis results from PMS data. A PSUR is required for class IIa/b and class III devices. Man­u­fac­tur­ers of high-risk devices must set up the reports on an annu­al basis and the doc­u­ments are reviewed and eval­u­at­ed by the NB. 


Fur­ther above, we looked at the gen­er­a­tion of clin­i­cal data for an appro­pri­ate set-up of the clin­i­cal eval­u­a­tion under the MDR. Against this back­ground, the MDR also includes cer­tain require­ments on PMS and PMCF in annex­es III and XIV. These are now gen­er­al pro­vi­sions for all man­u­fac­tur­ers and not nec­es­sar­i­ly new. Annex II of the MDD already oblig­es man­u­fac­tur­ers to present a PMCF Plan and results of PMCF. Nonethe­less, the MDR is much more explic­it in this regard. If, in the present case, the man­u­fac­tur­er can­not rely on own clin­i­cal data and there is, for exam­ple, a crit­i­cal inci­dent his­to­ry, the NB might require to launch a PMCF study. This in turn must be includ­ed in the PMCF plan and PMCF eval­u­a­tion report, which are required com­po­nents of a Tech­ni­cal File.

The last amend­ment to be men­tioned here refers to a new require­ment for implants, the implant card. The implant card con­tains spe­cif­ic prod­uct details, which are intend­ed “for the pur­pose of mak­ing it avail­able to the par­tic­u­lar patient who has been implant­ed with the device, by any means that allow rapid access to that infor­ma­tion” (Source: MDR).


Look­ing at the dis­cus­sion above, it becomes evi­dent that the impli­ca­tions of the MDR on a manufacturer’s Tech­ni­cal Doc­u­men­ta­tion are com­plex – each case must be regard­ed indi­vid­u­al­ly and care­ful­ly. Eco­nom­ic oper­a­tors should also bear in mind that the MDR is not only about Tech­ni­cal Doc­u­men­ta­tion. There are many more aspects that have to be con­sid­ered to com­ply with the new Regulation.

Sources: MDR, Euro­pean Patients Forum

See links below for fur­ther infor­ma­tion on Tech­ni­cal Documentation

Vis­it our page “Tech­ni­cal File Com­pi­la­tion”.
Vis­it our Sup­port­ing Infor­ma­tion Sec­tion on MDR / IVDR.
Should you require assis­tance in com­ply­ing with the MDR require­ments or on spe­cif­ic ques­tions, please don’t hes­i­tate to get in touch.