A Tech­ni­cal File – often referred as Tech­ni­cal Doc­u­men­ta­tion – is required for all prod­ucts falling under the med­ical devices leg­is­la­tion, includ­ing low risk class I med­ical devices, low risk in vit­ro diag­nos­tic (IVD) med­ical devices and cus­tom made devices. 

mdi Europa will help you to com­ply with the nec­es­sary leg­is­la­tion and assist in ensur­ing that your Tech­ni­cal File is ready for review by a Noti­fied Body (as and when nec­es­sary) or the local com­pe­tent author­i­ties in Europe.

Med­ical Devices Reg­u­la­tion (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR) require­ments on Tech­ni­cal Files

Under the MDR (EU) 2017/745 and IVDR (EU) 2017/746, require­ments have been expand­ed and substantiated:

  1. Device descrip­tion and spec­i­fi­ca­tions includ­ing vari­ants and accessories
  2. Infor­ma­tion to be sup­plied by the manufacturer
  3. Design and man­u­fac­tur­ing information
  4. Gen­er­al Safe­ty and Per­for­mance Requirements
  5. Ben­e­fit-risk analy­sis and risk management
  6. Prod­uct ver­i­fi­ca­tion and validation

In addi­tion, a sep­a­rate annex III has been ded­i­cat­ed to Post-Mar­ket Sur­veil­lance (PMS) require­ments for the Tech­ni­cal Documentation.

mdi Europa set up sup­port­ive doc­u­ments to assist man­u­fac­tur­ers in the com­pi­la­tion of their Tech­ni­cal Files. You may find fur­ther relat­ed infor­ma­tion using the links below or get in touch with our team. You are also invit­ed to make use of our exten­sive expert net­work should you require in-depth support. 

Check­lists, tem­plates and use­ful links regard­ing Tech­ni­cal Files