mdi Europa expe­ri­ence on MDR tech­ni­cal doc­u­men­ta­tion reviews

Under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) and Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR), EU Autho­rized Rep­re­sen­ta­tives are – among oth­ers – in charge of the ver­i­fi­ca­tion of the manufacturer’s tech­ni­cal documentation.

mdi Europa has ana­lyzed the past sub­mis­sions and list­ed below major con­cerns that often lead to seri­ous delays in the MDR con­for­mi­ty assess­ment procedure:

1. DEVICE DESCRIPTION AND SPECIFICATION

• Prod­uct claims were not uni­form through­out label­ing, risk man­age­ment, clin­i­cal eval­u­a­tion, and oth­er key documents.
• The ratio­nale for the prod­uct qual­i­fy­ing as a med­ical device was not includ­ed or not suf­fi­cient­ly explained.
• Ref­er­ence to pre­vi­ous and sim­i­lar prod­uct gen­er­a­tions was not suf­fi­cient­ly spec­i­fied and explained.

2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER

• Labels and instruc­tions for use were fre­quent­ly not set up in accor­dance with annex I. In addi­tion, in most cas­es, the tech­ni­cal doc­u­men­ta­tion includ­ed only one lan­guage ver­sion where­as label­ing trans­la­tions for all applic­a­ble tar­get coun­tries should be included.

3. DESIGN AND MANUFACTURING

• Man­u­fac­tur­ers should include com­pre­hen­sive infor­ma­tion about the design and man­u­fac­tur­ing process. In many cas­es, this part was not suf­fi­cient­ly spec­i­fied. Fre­quent­ly, only sim­ple flow charts where pro­vid­ed instead of detailed process descrip­tions ref­er­enc­ing to val­i­da­tion and ver­i­fi­ca­tion documents.

4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

• As there are cur­rent­ly no MDR or IVDR har­mo­nized stan­dards, the gen­er­al rec­om­men­da­tion is to apply the most recent stan­dard revi­sion and thus adher­ing to the state of the art. This has often not been done consistently.
• The check­list on the gen­er­al safe­ty and per­for­mance require­ments fre­quent­ly includ­ed a brief/ gen­er­al­ized ref­er­ence to stan­dards. How­ev­er, meth­ods that have been used for com­ply­ing with the cor­re­spond­ing require­ment, have not been explained often enough.
• In addi­tion, the ref­er­ence where evi­dence on require­ment com­pli­ance could be found in the tech­ni­cal doc­u­men­ta­tion was impre­cise in many cases.

5. CLINICAL EVALUATION

• Clin­i­cal eval­u­a­tions so far often seemed to include sig­nif­i­cant for­mal non- con­for­mi­ties. For exam­ple, the require­ments on the clin­i­cal eval­u­a­tion plan or the state of the art includ­ing alter­na­tive treat­ment options were not appro­pri­ate­ly addressed. But also sig­nif­i­cant process non-con­for­mi­ties could often be found. For exam­ple, lit­er­a­ture was used from devices where equiv­a­lence has not been evi­denced. Again, these are just some promi­nent examples.

6. PMS

• Although we have fre­quent­ly received PMS plans that work through the require­ments list­ed in annex III of the MDR, many points tend to be rep­re­sent­ed in a gener­ic man­ner despite the fact that annex III for­mu­lates very spe­cif­ic require­ments, e.g. ref­er­ence pro­ce­dures, ref­er­ence pro­to­cols, thresh­old values. 

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing arti­cles and con­tent on our website

• Search our web­site for Tech­ni­cal Documentation
• Tech­ni­cal Doc­u­men­ta­tion for­mat under the MDR and IVDR
• Clin­i­cal eval­u­a­tion and equiv­a­lence – using lit­er­a­ture under the MDR
• Prac­ti­cal advice for set­ting up an MDR and IVDR com­pli­ant PMS Plan